Published Manuscripts

Abstract

Background: Vigorous physical activity has been associated with lower risk of fatal prostate cancer. However, mechanisms contributing to this relationship are not understood.

Methods: We studied 117 men with prostate cancer in the University of North Carolina Cancer Survivorship Cohort (UNC CSC) who underwent radical prostatectomy and 101 radiation-treated patients with prostate cancer in FASTMAN. Structured questionnaires administered in UNC CSC assessed physical activity. In both studies, digital image analysis of hematoxylin and eosin-stained tissues was applied to quantify tumor-infiltrating lymphocytes in segmented regions. NanoString gene expression profiling in UNC CSC and microarray in FASTMAN were performed on tumor tissue, and a 50-gene signature utilized to predict immune cell types.

Results: Vigorous recreational activity, reported by 34 (29.1%) UNC CSC men, was inversely associated with tumor-infiltrating lymphocyte abundance. Tumors of men reporting any vigorous activity versus none showed lower gene expression-predicted abundance of Th, exhausted CD4 T cells, and macrophages. T-cell subsets, including regulatory T cells, Th, Tfh, exhausted CD4 T cells, and macrophages, were associated with an increased risk of biochemical recurrence, only among men with ERG-positive tumors.

Conclusions: Vigorous activity was associated with lower prostate tumor inflammation and immune microenvironment differences. Macrophages and T-cell subsets, including those with immunosuppressive roles and those with lower abundance in men reporting vigorous exercise, were associated with worse outcomes in ERG-positive prostate cancer.

Impact: Our novel findings contribute to our understanding of the role of the tumor immune microenvironment in prostate cancer progression and may provide insights into how vigorous exercise could affect prostate tumor biology.

Abstract

Background: Rapid growth in the number of U.S. cancer survivors drives the need for ongoing research efforts to improve outcomes and experiences after cancer. Here we describe the University of North Carolina (UNC) Cancer Survivorship Cohort, a medical center-based cohort of adults with cancer that integrates medical record-abstracted cancer information, patient-reported outcomes, and biologic specimens.

Methods: Participants ages 18+ were recruited from UNC oncology clinics between April 2010 and August 2016. After enrollment, participants completed questionnaires on a range of topics including demographics, health history, health care access and utilization, quality of life, and symptoms. Blood samples and tumor tissue specimens were collected and processed by study staff, and cancer characteristics and other clinical data were abstracted from electronic medical records. Participants consented to recontact for future studies and linkage of their data with other data resources.

Results: In total, 3,999 participants with a cancer diagnosis were enrolled in the cohort. The most common cancer types among those enrolled included breast (N=866), uterine (N=458), colorectal (N=300), prostate (N=296), and head and neck (N=248). Blood specimens were collected for 3,027 (76%). Additional participants without cancer (N=1,299) were also enrolled, and the majority (62%) provided biospecimen samples.

Conclusions: We encourage wide collaboration with investigators across institutions seeking to advance research in cancer survivorship. Procedures are in place to support proposals for use of existing or linked data and for proposals that require participant recontact or analysis of biospecimens.

Impact: The UNC Cancer Survivorship Cohort is a unique resource for cancer survivorship research.

Abstract

Purpose: Adolescents and young adult (AYA) cancer survivors (15-39 years at diagnosis) are at risk for treatment-related late effects but face barriers in accessing survivorship care. We examined the prevalence of five health care access (HCA) barriers: affordability, accessibility, availability, accommodation, and acceptability.

Methods: We identified AYA survivors from the University of North Carolina (UNC) Cancer Survivorship Cohort who completed a baseline questionnaire in 2010-2016. Participants had a history of cancer, were ≥18 years of age, and receiving care at a UNC oncology clinic. The sample was restricted to AYA survivors who were interviewed ≥1 year postdiagnosis. We used modified Poisson regression to estimate prevalence ratios (PRs) for the association between HCA barriers and self-reported fair or poor health, adjusted for sociodemographic and cancer characteristics.

Results: The sample included 146 AYA survivors who were a median age of 39 at the time of the survey. The majority (71%)-and 92% of non-Hispanic Black survivors-reported at least one HCA barrier, including acceptability (40%), accommodation (38%), or affordability (31%). More than one-quarter of survivors (28%) reported fair or poor health. Affordability barriers (PR: 1.89, 95% confidence interval [CI]: 1.13-3.18) and acceptability barriers (PR: 1.60, 95% CI: 0.96-2.66) were associated with a higher prevalence of fair/poor health, as were the cumulative effects of multiple HCA dimensions reported as barriers.

Conclusions: Barriers across multiple HCA dimensions were prevalent and associated with worse health in AYA survivors. Findings highlight the need to better understand and target specific barriers to care for diverse AYA survivors to improve their long-term health.

Keywords: adolescents and young adults; barriers to care; cancer; health care access; survivorship.

Abstract

Objectives: Patients with advanced cancer and minor children experience high rates of depression and anxiety. However, associations between parental status and other aspects of the patient experience are not well understood. This study compared patient-reported outcomes of patients with and without minor children.

Sample & setting: This was a retrospective analysis of 448 adults with stage III or IV solid tumors from a public research registry.

Methods & variables: Multiple linear regression models or modified Poisson regression models were fitted to evaluate differences in health-related quality of life, global health, and patient satisfaction scores between patients living with and without minors.

Results: One in five patients lived with minor children. They reported significantly worse health-related quality of life, global physical health, and global mental health. They also expressed lower satisfaction with time spent with their provider, communication, and financial aspects.

Implications for nursing: Patients with minor children may benefit from earlier identification and support for their psychosocial needs and concerns.

Keywords: Advanced Cancer; Health-Related Quality of Life; Minor Children; Patient Satisfaction.

Abstract

Purpose: To assess the prevalence and predictors of mental health disorders (MDHs) among head and neck squamous cell carcinoma (HNSCC) survivors, and the association with health-related quality of life (HRQOL), pain, and survival outcomes.

Materials and methods: This was a retrospective, cross-sectional study of HNSCC survivors surveyed at an outpatient oncology clinic from May 2012 through July 2016.

Results: Among 198 HNSCC survivors, 21% reported a MHD. Female sex (OR 6.60, 95% CI 2.08 to 20.98; p = 0.001) and Medicare insurance status (OR 4.95, 95% CI 1.52 to 16.11; p = 0.008) were significant predictors of reporting a MHD in the fully adjusted model. Patients reporting a MHD reported significantly worse pain (p < 0001) and worse HRQOL on the PROMIS Physical (p < 0.001), PROMIS Mental (p < 0.001), and FACT-GP (p < 0.026) questionnaires. Diagnosis of a MHD was not correlated with 5-year OS (74% vs. 84%; p = 0.087).

Conclusion: Initiatives for early identification and intervention of MHDs as part of survivorship initiatives may engender clinically meaningful outcomes in head and neck cancer.

Keywords: Anxiety; Depression; Head and neck neoplasms; Mental disorders; Quality of life; Survival.

Abstract

Background: There is a paucity of data on financial toxicity among patients with head and neck squamous cell carcinoma (HNSCC).

Materials: This was a retrospective, cross-sectional study of patients with HNSCC surveyed at an outpatient oncology clinic.

Results: The sample included 202 patients with HNSCC with a mean age of 59.6 years (SD 10.0). There were 53 patients (26%) with self-reported financial
burden. Education of high school or less was a significant predictor of self reported financial burden (OR 2.52, 95% CI 1.03–6.14, p = 0.042). Patients
reporting financial burden had significantly worse physical (p = 0.003), mental(p = 0.003), and functional (p = 0.036) health-related quality of life (HRQOL).
Patients reporting financial burden appeared to have lower 5-year overall survival(74.3% vs. 83.9%, p = 0.165), but this association did not reach statistical significance.

Conclusion: Financial burden or toxicity may affect approximately a quarter of patients with HNSCC and appears to be associated with worse HRQOL outcomes.

KEYWORDS: cancer survivors, cost of illness, head and neck neoplasms, health expenditures, patient reported outcomes, quality of life

Abstract

Objective: To examine the prevalence and predictors of patient-reported barriers to care among survivors of head and neck squamous cell carcinoma and the association with health-related quality of life (HRQOL) outcomes.

Study design: Retrospective cohort study.

Setting: Outpatient oncology clinic at an academic tertiary care center.

Methods: Data were obtained from the UNC Health Registry/Cancer Survivorship Cohort. Barriers to care included self-reported delays in care and inability to obtain needed care due to cost. HRQOL was measured with validated questionnaires: general (PROMIS) and cancer specific (FACT-GP).

Results: The sample included 202 patients with head and neck squamous cell carcinoma with a mean age of 59.6 years (SD, 10.0). Eighty-two percent were male and 87% were White. Sixty-two patients (31%) reported at least 1 barrier to care. Significant predictors of a barrier to care in unadjusted analysis included age ≤60 years (P = .007), female sex (P = .020), being unmarried (P = .016), being uninsured (P = .047), and Medicaid insurance (P = .022). Patients reporting barriers to care had significantly worse physical and mental HRQOL on the PROMIS questionnaires (P < .001 and P = .002, respectively) and lower cancer-specific HRQOL on the FACT-GP questionnaire (P < .001), which persisted across physical, social, emotional, and functional domains. There was no difference in 5-year OS (75.3% vs 84.1%, P = .177) or 5-year CSS (81.6% vs 85.4%, P = .542) in patients with and without barriers to care.

Conclusion: Delay- and affordability-related barriers are common among survivors of head and neck cancer and appear to be associated with significantly worse HRQOL outcomes. Certain sociodemographic groups appear to be more at risk of patient-reported barriers to care.

Keywords: barriers; head and neck neoplasms; health services accessibility; patient-reported outcome measures; survivorship.

Abstract

PURPOSE: Obesity may alter mononuclear phagocyte system (MPS) function and the pharmacology and efficacy of nanoparticles therapies, such as PEGylated liposomal doxorubicin (PLD). We aimed to evaluate the relationships between hormone and chemokine mediators of MPS function and the pharmacokinetic (PK) exposure of PLD in obese and normal weight patients with ovarian and endometrial cancer.

METHODS: Hormone and chemokine mediators in obese and normal weight ovarian and endometrial cancer patients were measured. A separate pharmacology study was performed that evaluated the relationship between serum hormone concentrations, MPS function, and PK disposition of PLD in refractory ovarian cancer patients.

RESULTS: Univariate analysis revealed a significant relationship between serum estradiol and body mass index (OR 8.64, 95% CI 2.67-28.0, p < 0.001). Estrone and testosterone concentrations were positively correlated with MPS function (ρ = 0.57 and 0.53, p = 0.14 and 0.18, respectively) and inversely correlated with PLD PK exposure (ρ = - 0.75 and - 0.76, respectively, p = 0.02 for both).

CONCLUSIONS: Higher MPS function resulting in reduced PLD exposure is a potential mechanism for reduced efficacy of PLD and other nanoparticles observed in obese patients with cancer. PK simulations suggest higher doses of PLD are required in obese patients to achieve similar exposures as standard dosing in normal weight patients.

KEYWORDS: Endometrial cancer; Estradiol; Nanoparticle; Obesity; Ovarian cancer; Pharmacology

Abstract

PURPOSE: In older women, breast cancer and its treatment can have profound impact on their physical, mental, and social health, especially in frail patients. This study evaluated the association between frailty and long-term health-related quality of life (HRQOL) in older women undergoing breast cancer treatment.

METHODS: Using the Carolina Senior Registry (CSR), participants with breast cancer were contacted to complete a follow-up HRQOL questionnaire (median 4 years). Baseline Geriatric Assessment (GA) variables were used to calculate the Carolina Frailty Index (CFI) and categorize participants as robust, pre-frail, or frail. Outcomes included HRQOL domains of physical function, social roles, fatigue, depression, anxiety, pain, and sleep disturbance assessed using PROMIS® instruments. Regression modeling compared outcomes between frailty groups using adjusted mean differences (AMD).

RESULTS: Of 190 eligible patients, 63 completed follow-up HRQOL survey. Mean age was 70 years (range 65-86) and 91% were white. Based on the CFI, 49 (78%) patients were robust, 11 (18%) pre-frail, and 3 (5%) frail. After controlling for age and cancer stage, patients identified as pre-frail/frail reported worse physical function (AMD - 9.2, p < 0.001) and social roles (AMD - 7.2, p = 0.002) and more fatigue (AMD 7.6, p = 0.008), depression (AMD 5.6, p = 0.004), and sleep disturbance (AMD 6.9, p = 0.008) compared to robust patients at follow-up.

CONCLUSIONS: Frailty in older women with breast cancer was associated with worse long-term HRQOL outcomes. Further research is needed to develop interventions for frail patients at-risk for reduced HRQOL.

KEYWORDS: Breast cancer; Frailty; Geriatric assessment; Geriatric oncology; Health-related quality of life

Abstract

PURPOSE: Because of the escalating cost of cancer care coupled with high insurance deductibles, premiums, and uninsured populations, patients with cancer are affected by treatment-related financial harm, known as financial toxicity. The purpose of this study was to describe individuals reporting financial toxicity and to identify rates of and reasons for affordability-related treatment noncompliance.

METHODS: From May 2010 to November 2015, adult patients (age ≥ 18 years) with cancer were identified from a Health Registry/Cancer Survivorship Cohort. Financial toxicity was defined as agreement with the phrase "You have to pay for more medical care than you can afford" from the Patient Satisfaction Questionnaire-18. Logistic regression and Fisher exact tests were used to compare groups.

RESULTS: Of 1,988 participants, 524 (26%) reported financial toxicity. Patients reporting financial toxicity were more likely age 65 years or younger, female, nonwhite, non-English speaking, not married, less educated, and to have received a diagnosis more recently (all P < .001). Participants with financial toxicity were more likely to report noncompliance with medication, owing to inability to afford prescription drugs (relative risk [RR], 3.55; 95% CI, 2.53 to 4.98), and reported forgoing mental health care (RR, 3.89; 95% CI, 2.04 to 7.45), doctor's visits (RR, 2.98; 95% CI, 1.97 to 4.51), and medical tests (RR, 2.54; 95% CI, 1.49 to 4.34). The most endorsed reasons for delayed care were not having insurance coverage and being unable to afford household expenses.

CONCLUSION: More than 25% of adults with cancer reported financial toxicity that was associated with an increased risk for medical noncompliance. Financial toxicity remains a major issue in cancer care, and efforts are needed to ensure patients experiencing high levels of financial toxicity are able to access recommended care.

Abstract

PURPOSE: Costly surveillance and treatment of bladder cancer can lead to financial toxicity, a treatment related financial burden. Our objective was to define the prevalence of financial toxicity among patients with bladder cancer and identify delays in care and its effect on health related quality of life.

MATERIALS AND METHODS: We identified patients with bladder cancer in the University of North Carolina Health Registry/Cancer Survivorship Cohort. Financial toxicity was defined as agreement with having "to pay more for medical care than you can afford." Health related quality of life was measured using general and cancer specific validated questionnaires. Statistical analyses were performed using the Fisher exact test and the Student t-test.

RESULTS: A total of 138 patients with bladder cancer were evaluated. Median age was 66.9 years, 75% of the patients were male and 89% were white. Of the participants 33 (24%) endorsed financial toxicity. Participants who were younger (p = 0.02), black (p = 0.01), reported less than a college degree (p = 0.01) and had noninvasive disease (p = 0.04) were more likely to report financial toxicity. On multivariable analysis only age was a significant predictor of financial toxicity. Patients who endorsed financial toxicity were more likely to report delaying care (39% vs 23%, p = 0.07) due to the inability to take time off work or afford general expenses. On general health related quality of life questionnaires patients with financial toxicity reported worse physical and mental health (p = 0.03 and <0.01, respectively), and lower cancer specific health related quality of life (p = 0.01), physical well-being (p = 0.01) and functional well-being (p = 0.05).

CONCLUSIONS: Financial toxicity is a major concern among patients with bladder cancer. Younger patients were more likely to experience financial toxicity. Those who endorsed financial toxicity experienced delays in care and poorer health related quality of life, suggesting that treatment costs should have an important role in medical decision making.

Abstract

Background: Social stressors, such as social relationship deficits, have been increasingly linked to chronic disease outcomes, including cancer. However, critical gaps exist in our understanding of the nature and strength of such links, as well as the underlying biological mechanisms relating social relationships to cancer progression and survival.

Methods: Utilizing novel questionnaire and biomarker data from the UNC Health Registry/Cancer Survivorship Cohort, this study examines the associations between diverse measures of social support and mortality risk among individuals with cancer (N = 1,004). We further assess the role of multiple serum markers of inflammation, including high-sensitivity C-reactive protein (CRP), IL6, TNFα, and VEGF, as potential mediators in the social relationship-cancer link.

Results: The findings revealed that one's appraisal of their social support was associated with cancer mortality, such that individuals reporting higher levels of social support satisfaction had lower mortality risk than individuals reporting lower levels of satisfaction. The amount of support received, on the other hand, was not predictive of cancer survival. We further found evidence that inflammatory processes may undergird the link between social support satisfaction and mortality among individuals with cancer, with individuals reporting higher levels of social support satisfaction having lower levels of CRP, IL6, and TNFα.

Conclusions: These results provide new knowledge of the biosocial processes producing population disparities in cancer outcomes.

Impact: Our study offers new insights for intervention efforts aimed at promoting social connectedness as a means for improving cancer survival.

Abstract

PURPOSE: Cancer survivors are at increased risk for the early development of age-related chronic medical conditions compared with peers without a history of cancer; however, little is known regarding the burden of these conditions among survivors of adolescent and young adult (AYA) cancers. In response, we sought to determine the prevalence of specific comorbidities and frailty among AYAs (15-39 years old at diagnosis) enrolled in a cancer survivorship cohort.

METHODS: Using a cross-sectional survey of a tertiary medical center-based cancer survivorship cohort, we determined the prevalence of specific comorbidities and frailty using the survey-based FRAIL assessment. In separate models adjusting for age, we estimated prevalence ratios (PRs) for the associations between patient characteristics and (1) any comorbidity and (2) frailty or prefrailty using log-binomial models.

RESULTS: We identified 271 AYA cancer survivors, most of whom were 30-39 years old at survey (57%). A majority of survivors (n = 163, 60%) reported having at least one comorbidity with the most common being depression (28%), anxiety (27%), asthma (17%), high cholesterol (15%), and hypertension (15%). Of the 184 AYA survivors at least 1 year from cancer diagnosis, 19 (10%) were classified as frail and 39 (21%) as prefrail. Survivors who were smokers (PR 2.0, 95% confidence interval [CI]: 1.16-3.56); obese (PR 1.7, 95% CI: 1.10-2.55); uninsured (PR 2.7, 95% CI: 1.63-4.59); or who reported comorbid depression or anxiety (PR 2.4, 95% CI: 1.51-3.67) were more likely to be frail or prefrail.

CONCLUSIONS: The prevalence of frailty and comorbidities is high among AYA cancer survivors suggestive of accelerated aging.

KEYWORDS: comorbidities; frailty; survivorship

Abstract

OBJECTIVES:

Sexual health in survivors of gynecologic cancer has been studied; however, sexual health in these women before treatment has not been thoroughly evaluated. The objective of our study was to describe the pretreatment characteristics of sexual health of women with suspected gynecologic cancer before cancer treatment.

MATERIALS AND METHODS:

We performed a cross-sectional analysis of women with a suspected gynecologic cancer, who were prospectively enrolled in a hospital-based cancer survivorship cohort from August 2012 to June 2013. Subjects completed the validated Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction Questionnaire. Pretreatment sexual health was assessed in terms of sexual interest, desire, lubrication, discomfort, orgasm, enjoyment, and satisfaction.

RESULTS:

Of 186 eligible women with suspected gynecologic cancer, 154 (82%) completed the questionnaire pretreatment. Mean age was 58.1 ± 13.3 years. Sexual health was poor: 68.3% reported no sexual activity, and 54.7% had no interest in sexual activity. When comparing our study population to the general U.S. population, the mean pretreatment scores for the subdomains of lubrication and vaginal discomfort were similar, while sexual interest was significantly lower and global satisfaction was higher. In a linear regression model, controlling for cancer site, age remained significantly associated with sexual function while cancer site did not.

CONCLUSIONS:

Problems with sexual health are prevalent in women with suspected gynecologic malignancies before cancer treatment. Increasing awareness of the importance of sexual health in this population will improve quality of life for these women.

KEYWORDS:

gynecologic cancer; quality of life; sexual health

Abstract

OBJECTIVES:

For women with gynecologic cancer, the impact of surgery on sexual interest and desire in the immediate and later postoperative period is not well characterized. The objective of this study was to report the perioperative trends of changing sexual interest and desire in a cohort of women undergoing surgery for suspected gynecologic malignancies.

METHODS:

This is an ancillary analysis of a cohort study analyzing health-related outcomes in women who underwent primary surgical management of a suspected gynecologic malignancy between 10/2013 and 10/2014. Subjects completed the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction Questionnaire (PROMIS-SFQ) preoperatively and questions on sexual interest and desire at one, three, and six months postoperatively. Bivariate tests and multiple linear regression were used to analyze data.

RESULTS:

Of 231 women who completed a baseline PROMIS-SFQ, 187 (81%) completed one-month, 170 (74%) three-month, and 174 (75%) six-month follow-up interviews. Following surgery, 71% of enrolled subjects were diagnosed with a malignancy. Women age <55 had a greater decrease in sexual interest from baseline to one month than women age >55 (-5.5±1.0 vs -2.3±0.9, p=0.02). In a multivariable analysis, age <55 remained associated with a larger decrease in sexual interest at one month postoperatively (-4.6, 95% CI: -1.8, -7.4), as did having cancer vs benign disease for women of all ages (-5.6, 95% CI: -9.6, -1.5).

CONCLUSIONS:

This study provides new data regarding the timing and magnitude of changes in sexual interest following gynecologic oncology procedures.

Abstract

Purpose: This study aims to (1) describe the activities, function, and health-related quality of life (HRQOL) of a large sample of older adults (age > 65) with cancer, (2) identify the associations with demographics, cancer type, comorbid conditions, and ability to participate in activities and functional status.

Methods: The Health Registry/Cancer Survivorship Cohort is an institutional database designed to aid cancer survivorship research. The registry includes three measures of patient-reported HRQOL: FACT-G and PROMIS® Global measures for physical and mental health. Other measures included in the registry are cancer type, number of comorbid conditions and specific conditions and their limitations in daily activity, and self-reported daily activity/function.

Results: Our sample consists of 768 older adults with cancer, mean age 72 years, 60% female, and 90% White. Mean scores for HRQOL: FACT-G (85, range: 25-108), PROMIS-physical (48, range: 16-67) and, PROMIS-mental (51, range: 21-67). In multivariable models, Black race, one or more comorbid conditions, and Gastrointestinal cancer (p < .05), and patient- reported decreased levels of activities/function were all independently associated with poor HRQOL (p < .0001).

Conclusions: Older Black adults with cancer, those that have high comorbidity burden, with gastrointestinal cancers and those that report decreased ability to participate in daily activities/ function reported poorer HRQOL. As geriatric oncology moves towards trying to identify who may need supportive services, this study demonstrated that a one question patient-reported level of activities and functional ability were independently associated with physical, mental, and cancer-specific HRQOL.

Keywords: Health-related quality of life, functional status, older adults, supportive services, neoplasm, activities

Abstract

Purpose
This study evaluated the feasibility and preliminary efficacy of two 6-month, self-regulation interventions that focused on daily self-weighing (DSW) and used objective monitoring and tailored feedback about weight (±activity), to prevent weight gain among African American breast cancer survivors.

Methods
Participants (n = 35) were randomized to an intervention + activity monitoring (INT+), intervention (INT), or control (CON) group. Interventions included a wireless scale (±activity tracker) that transmitted objective data to a mobile app/website, emailed lessons, and tailored feedback based on objective weight (±activity data). Participants completed inperson and online assessments at baseline, 3 months, and 6 months.

Results
Ninety-four percent of participants completed assessments at 3 months, and 97 % at 6 months. Median (IQR) weight change after 6 months was −0.9 % (−4.4–0.1) in the INT+ (p = 0.075; p = 0.067 vs. CON) and −0.2 % (−4.2–1.3) in the INT groups (p = 0.463; p = 0.357 vs. CON), versus a 0.2 % (−0.7–1.7) gain in the CON group. The proportion of INT+, INT, and CON participants that were at or below baseline weight was 72.7, 53.8, and 45.5 %, respectively (effectsizes d = 0.64, d = 0.18).Most INT+ participants weighed and wore trackers ≥5 days/week (INT+, 81.9 % vs. INT, 38.5% vs. CON, 0 %; p < 0.0005; INT+, 72.7 %). Both intervention groups perceived DSWas positive, and 100 % would recommend the program to other breast cancer survivors.

Conclusion
An intervention focused on DSW as a selfmonitoring strategy shows promise for preventing weight gain in breast cancer survivors.

Implications for cancer survivors Daily self-monitoring of weight and activity may be a feasible and accessible approach to promote weight gain prevention in breast cancer survivors. Clinical trial registration ClinicalTrials.gov, NCT02030353

Keywords
Breast cancer survivors . African American . Randomized trial .Weight gain prevention . Intervention . Technology

Abstract

PURPOSE:

Endocrine therapy for breast cancer can exacerbate menopausal symptoms. The association between endocrine therapy and common pelvic floor disorders including urinary incontinence has rarely been evaluated. We examined urogenital and sexual side effects among women with a breast cancer diagnosis, comparing endocrine therapy users to nonusers.

METHODS:

Urogenital and sexual symptoms were self-reported during the enrollment interview within the University of North Carolina Cancer Survivorship Cohort. Tumor characteristics and endocrine therapy use were collected from medical and prescription records. We calculated multivariable prevalence ratios (PR) and 95 % confidence intervals (CI) for the association of endocrine therapy (versus no endocrine therapy) and urinary incontinence, overall and by therapy type (tamoxifen or aromatase inhibitors). PROMIS Sexual Function and Satisfaction domain scores were compared across endocrine therapy groups.

RESULTS:

Among the 548 women with a breast cancer diagnosis, 49 % received endocrine therapy. Overall, 18 % of women reported urinary incontinence symptoms. We observed no association between urinary incontinence and endocrine therapy use overall (PR = 0.97; 95 % CI 0.67, 1.43), tamoxifen (PR = 1.20; 95 % CI 0.74, 1.96), or aromatase inhibitors (PR = 0.89; 95 % CI 0.55, 1.42), compared to no use. Approximately 55 % of women were sexually active. Sexual function scores did not vary according to endocrine therapy use, although urinary incontinence was associated with lower satisfaction scores (p = 0.05).

CONCLUSIONS:

Our findings demonstrate a high prevalence of urinary incontinence after breast cancer diagnosis similar to the overall prevalence in older U.S. women, and this did not vary strongly according to use of endocrine therapy.

KEYWORDS:

Cancer survivors; Endocrine therapy; Patient-reported outcomes; Sexual function; Urinary incontinence

Abstract

BACKGROUND: There are currently no assessments of the impact of surgical complications on health-related quality of life in gynecology and gynecologic oncology. This is despite complications being a central focus of surgical outcome measurement, and an increasing awareness of the need for patient-reported data when measuring surgical quality.

OBJECTIVE: We sought to measure the impact of surgical complications on health-related quality of life at 1 month postoperatively, in women undergoing gynecologic and gynecologic oncology procedures.

STUDY DESIGN: This is a prospective cohort study of women undergoing surgery by gynecologic oncologists at a tertiary care academic center from October 2013 through October 2014. Patients were enrolled preoperatively and interviewed at baseline and 1, 3, and 6 months postoperatively. Health-related quality of life measures included validated general and disease-specific instruments, measuring multiple aspects of health-related quality of life, including anxiety and depression. The medical record was abstracted for clinical data and surgical complications were graded using validated Clavien-Dindo criteria, and women grouped into those with and without postoperative complications. Bivariate statistics, analysis of covariance, responder analysis, and multivariate modeling was used to analyze the relationship of postoperative complications to change health-related quality of life from baseline to 1 month. Plots of mean scores and change over time were constructed.

RESULTS: Of 281 women enrolled, response rates were 80% (n = 231/281) at baseline, and from that cohort, 81% (n = 187/231), 74% (n = 170/231), and 75% (n = 174/231) at 1, 3, and 6 months, respectively. The primary analytic cohort comprised 185 women with completed baseline and 1-month interviews, and abstracted clinical data. Uterine (n = 84, 45%), ovarian (n = 23, 12%), cervical (n = 17, 9%), vulvar (n = 3, 2%), and other (n = 4, 2%) cancers were represented, along with 53 (30%) cases of benign disease. There were 42 (24%) racial/ethnic minority women. Minimally invasive (n = 115, 63%) and laparotomy (n = 60, 32%) procedures were performed. Postoperative complications occurred in 47 (26%) of patients who experienced grade 1 (n = 12), grade 2 (n = 29), and grade 3 (n = 6) complications. At 1 month, physical (20.6 vs 22.5, P = .04) and functional (15.4 vs 18.3, P = .02) well-being, global physical health (43.1 vs 46.3, P = .02), and work ability (3 vs 7.2, P = .001) were lower in postoperative complication vs non-postoperative complication women. Relative change, however, in most health-related quality of life domains from baseline to 1 month did not differ between postoperative complication and nonpostoperative complication groups. Postoperative complication patients did have increased odds of sustained or worsened anxiety at 1 month vs baseline (odds ratio, 2.5; 95% confidence interval, 1.2-5.0) compared to nonpostoperative complication patients.

CONCLUSION: Collectively, women who experienced postoperative complications after gynecologic and gynecologic oncology procedures did not appear to have differences in most health-related quality of life trends over time compared to those who did not. An exception was anxiety, where postoperative complications were associated with sustained or worsened levels of high anxiety after surgery.

KEYWORDS: gynecologic oncology; postoperative complications; quality of life; surgery

Abstract

OBJECTIVE: To examine associations between non-modifiable patient factors and patient satisfaction (PS) among women presenting to a gynecologic oncology clinic.

METHODS: This is a cross sectional analysis of patients presenting for surgical management by a gynecologic oncologist at a tertiary care academic medical center. The Patient Satisfaction Questionnaire (PSQ-18) that measures PS in seven domains of health care was administered. Scores were converted to "satisfied" versus "unsatisfied/equivocal". Demographic and medical factors were obtained from the medical record. Chi-square, t-tests, and multivariable logistic regression were used.

RESULTS: 208 patients completed the baseline patient satisfaction questionnaire and the median PSQ-18 score was 70.5 (range: 42-90). Median age was 58years (range: 22-93). Several non-modifiable factors were associated with PS. White patients had higher interpersonal PS than minorities (86% v 65%, p=0.002). The uninsured had lower interpersonal (60% v 86%, p=0.003) and accessibility PS (33% v 67%, p=0.03). Increasing education and less time travelled to care were both associated with higher interpersonal (p=0.03, p=0.05) and accessibility PS (p=0.01, p=0.01). There was no association between clinical factors (BMI, comorbidities, cancer) and PS. In multivariable analysis, the strongest predictor of interpersonal PS was white race while the strongest predictors of accessibility PS were time travelled to care and insurance status.

CONCLUSIONS: Patient satisfaction scores among patients presenting to a gynecologic oncology clinic are associated with non-modifiable demographic, financial and geographic factors. Pay for performance measures that use summed patient satisfaction scores may penalize hospitals for patient-mix driven differences.

Abstract

OBJECTIVE: To report the changes in patient-reported quality of life for women undergoing gynecologic oncology surgeries.

METHODS: In a prospective cohort study from 10/2013-10/2014, women were enrolled pre-operatively and completed comprehensive interviews at baseline, 1, 3, and 6months post-operatively. Measures included the disease-specific Functional Assessment of Cancer Therapy-General (FACT-GP), general Patient Reported Outcome Measure Information System (PROMIS) global health and validated measures of anxiety and depression. Bivariate statistics were used to analyze demographic groups and changes in mean scores over time.

RESULTS: Of 231 patients completing baseline interviews, 185 (80%) completed 1-month, 170 (74%) 3-month, and 174 (75%) 6-month interviews. Minimally invasive (n=115, 63%) and laparotomy (n=60, 32%) procedures were performed. Functional wellbeing (20 → 17.6, p<0.0001) decreased at 1-month, and recovered by 3 and 6months. Emotional wellbeing increased (16.3 → 20.1, p<0.0001) and anxiety decreased (54.2 → 49.0, p<0.0001) at 1-month, and were stable at 3 and 6months. Physical wellbeing scales were not sensitive to surgery. These patterns were consistent across procedure type, cancer diagnosis, and adjuvant therapy administration. In an exploratory analysis of the interaction of QOL and quality, patients with increased postoperative healthcare resource use were noted to have higher baseline levels of anxiety.

CONCLUSIONS: For women undergoing gynecologic oncology procedures, temporary declines in functional wellbeing are balanced by improvements in emotional wellbeing and decreased anxiety symptoms after surgery. Not all commonly used QOL surveys are sensitive to changes during the perioperative period and may not be suitable for use in surgical quality metrics.

Abstract

INTRODUCTION AND HYPOTHESIS: Understanding of pelvic floor disorders among women with gynecological cancer is limited. The objective of this study was to describe the prevalence of pelvic floor disorders in women with suspected gynecological malignancy before surgery.

METHODS: A cross-sectional study was performed of women aged ≥18 with a suspected gynecological malignancy who enrolled in the University of North Carolina Health Registry/Cancer Survivorship Cohort (HR/CSC) from August 2012 to June 2013. Demographics were obtained from the HR/CSC self-reported data; clinical data were abstracted from the electronic medical record. Subjects completed validated questionnaires (Rotterdam Symptom Checklist and the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptoms) to assess bladder and bowel function.

RESULTS: Among 186 women scheduled for surgery for gynecological malignancy, 152 (82 %) completed baseline assessments before surgery. Mean age was 58.1 ± 13.3 years, and mean BMI was 33.6 ± 8.8 kg/m(2). The majority of subjects had uterine cancer (61.8 %), followed by ovarian (17.1 %) and cervical (11.1 %). At baseline, the rate of urinary incontinence (UI) was 40.9 %. A third of subjects reported stress UI, and one quarter reported urge UI. The overall rate of fecal incontinence was 3.9 %, abdominal pain was 47.4 %, constipation was 37.7 %, and diarrhea was 20.1 %. When comparing cancer types, there were no differences in pelvic floor symptoms.

CONCLUSION: Pelvic floor disorders are common in women with suspected gynecological malignancy at baseline before surgery. Recognizing pelvic floor disorders in the preoperative setting will allow for more individualized, comprehensive care for these women.

Abstract

OBJECTIVE: Although older patients represent the most rapidly growing segment of the oncology population, clinical care is guided by very little data on patient-reported outcomes, particularly satisfaction with healthcare. Using a large cancer center registry, we sought to describe factors associated with satisfaction with care for older and younger oncology patients.

METHODS: Data were collected through the University of North Carolina Health Registry Cancer Survivorship Cohort. Satisfaction was measured with the Patient Satisfaction Questionnaire Short Form. Quality of life (QOL) measures included were the Promis Global short form and the Functional Assessment of Cancer Therapy General (FACT-G).

RESULTS: A total of 2385 patients were included. 460 (20%) were aged 70 and above (older group). Older patients reported significantly higher levels of satisfaction in domains of time spent with doctor (scores 3.84 versus 3.73 p=0.03) and financial aspects (scores 4.03 versus 3.44 p<0.001) compared to younger patients. In multivariable analysis, higher QOL scores and higher self-reported ECOG performance status were associated with higher satisfaction scores. African American race was associated with lower satisfaction scores in all age groups. QOL was more closely correlated with satisfaction in older patients compared to younger patients.

CONCLUSIONS: Older patients with cancer report higher levels of satisfaction with care, in part due to lesser financial burden of care. Better QOL is associated with satisfaction with care in older patients. Use of patient-reported outcomes such as patient satisfaction may help improve patient-centered geriatric oncology care.

KEYWORDS: Geriatric oncology; Patient satisfaction; Quality of life

Abstract

BACKGROUND: The objective of the current study was to evaluate the effect of obesity on pretreatment quality of life (QoL) in gynecologic oncology patients.

METHODS: The authors analyzed collected data from an institution-wide cohort study of women with gynecologic cancers enrolled from August 2012 to June 2013. The Functional Assessment of Cancer Therapy-General, site-specific symptom scales, and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) global mental and physical health tools were administered. Survey results were linked to clinical data abstracted from medical records (demographics and comorbid conditions). Bivariate tests and multivariate linear regression models were used to evaluate factors associated with QoL scores.

RESULTS: A total of 182 women with ovarian, uterine, cervical, and vulvar/vaginal cancers were identified; of these, 152 (84%) were assessed before surgery. Mean body mass index was 33.5 kg/m(2) and race included white (120 patients [79%]), black (22 patients [15%]), and other (10 patients [6.5%]). A total of 98 patients (64.5%) were obese (body mass index ≥30). On multivariate analysis, subscales for functional (17 vs 19; P = .04), emotional (16 vs 19; P = .008), and social (22 vs 24; P = .02) well-being as well as overall Functional Assessment of Cancer Therapy-General scores (77 vs 86; P = .002) and Patient-Reported Outcomes Measurement Information System global physical health scores (45 vs 49; P = .003) were found to be significantly lower in obese versus nonobese patients.

CONCLUSIONS: Before cancer treatment, obese patients with gynecologic malignancies appear to have worse baseline QoL than their normal-weight counterparts. Emerging models of QoL-based cancer outcome measures may disproportionately affect populations with a high obesity burden. The potential disparate impact of cancer therapy on longitudinal QoL in the obese versus nonobese patients needs to be evaluated.

KEYWORDS: female genital neoplasms; obesity; patient-centered outcomes research; preoperative period; quality of life

Abstract

OBJECTIVE: Quality of life (QoL) for women with gynecologic malignancies is predictive of chemotherapy related toxicity and overall survival but has not been studied in relation to surgical outcomes and hospital readmissions. Our goal was to evaluate the association between baseline, pre-operative QoL measures and 30-day post-operative morbidity and health resource utilization by gynecologic oncology patients.

METHODS: We analyzed prospectively collected survey data from an institution-wide cohort study. Patients were enrolled from 8/2012 to 6/2013 and medical record data was abstracted (demographics, comorbid conditions, and operative outcomes). Responses from several validated health-related QoL instruments were collected. Bivariate tests and multivariable linear and logistic regression models were used to evaluate factors associated with QoL scores.

RESULTS: Of 182 women with suspected gynecologic malignancies, 152 (84%) were surveyed pre-operatively and 148 (81%) underwent surgery. Uterine (94; 63.5%), ovarian (26; 17.5%), cervical (15; 10%), vulvar/vaginal (8; 5.4%), and other (5; 3.4%) cancers were represented. There were 37 (25%) cases of postoperative morbidity (PM), 18 (12%) unplanned ER visits, 9(6%) unplanned clinic visits, and 17 (11.5%) hospital readmissions (HR) within 30days of surgery. On adjusted analysis, lower functional well-being scores resulted in increased odds of PM (OR 1.07, 95%CI 1.01-.1.21) and HR (OR 1.11, 95%CI 1.03-1.19). A subjective global assessment score was also strongly associated with HR (OR 1.89, 95%CI 1.14, 3.16).

CONCLUSION: Lower pre-operative QoL scores are significantly associated with post-operative morbidity and hospital readmission in gynecologic cancer patients. This relationship may be a novel indicator of operative risk.

KEYWORDS: Postoperative recovery; Quality of life; Surgical complications

Abstract

Biobanks are a promising means for advancing biomedical knowledge in the twenty-first century. Also known as biorepositories, biobanks collect and store a range of biospecimens that are then available for later analysis in numerous types of studies. Although there are many kinds of biobanks, each with different purposes, those with the most powerful ramifications for human subjects protection share two common features: 1) they are repositories of human biospecimens (e.g., blood, urine, buccal cells, or leftover
tissue from biopsies or surgeries) that lend themselves to a wide range of molecular analysis, including genomic and proteomic analysis; and 2) they can include clinical, behavioral, and lifestyle information about the contributors gathered through medical record review and/or surveys.

Biobank research is fundamentally different from clinical trials and other research studies, thus presenting its own unique set of challenges for human subjects protection. Biobanks are a research resource, which means that participants’ biospecimens—as well as their medical records, information, and genetic research results—will be shared with many researchers, some of whom may not be affiliated with the biobank’s institution.

Although little is known about how individuals understand consent information for participation in biobank research, the handful of studies that have been conducted suggest that individuals recruited to participate may not understand the information conveyed to them in the way researchers intend. Thus, their consent may not be truly informed. Given the unique challenges associated with biobank research, it is important to explore strategies for conveying information in the consent process. An alternative to the traditional approach of a written consent document is to use multimedia tools—for example, video presentation of the consent information that can be paired with written consent documents and/or staff member support to answer questions. Such tools offer a strategy to convey consent information to prospective research participants in a manner that may enhance participants’ ability to pay attention to critical information and understand the information conveyed.