Published Manuscripts

Clarity and appeal of a multimedia informed consent tool for biobanking.
Author(s):
McGraw SA, Wood-Nutter CA, Solomon MZ, Maschke KJ, Bensen JT, Irwin DE.
Source:
IRB: Ethics & Human Research,
Published:
2012
Pages:
9-19

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.
Show More

Preoperative quality of life and surgical outcomes in gynecologic oncology patients: A new predictor of operative risk?
Author(s):
Doll, KM, Snavely, AC, Klinowski A, Irwin DE, Bensen JT, Bae-Jump V, Soper JT, Brewster WR, Gehrig PA.
Source:
Gynecologic Oncology,
Published:
June 2014
Pages:
546-51

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
Show More

Obesity is associated with worse quality of life in women with gynecologic malignancies: An opportunity to improve patient-centered outcomes.
Author(s):
Doll KM, Kalinowski AK, Snavely AC, Irwin DE, Bensen JT, Bae-Jump VL, Kim KH, Van Le L, Clarke-Pearson DL, Gehrig PA.
Source:
Cancer,
Published:
February 1, 2015
Pages:
395-402

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
Show More

Healthcare satisfaction in older and younger patients with cancer.
Author(s):
Mariano C, Hanson LC, Deal AM, Yang H, Bensen J, Hendrix L, Muss HB.
Source:
Journal of Geriatric Oncology,
Published:
January 7, 2016
Pages:
32-8

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
Show More

Prevalence of pelvic floor disorders in women with suspected gynecological malignancy: a survey-based study.
Author(s):
Bretschneider EC, Doll KM, Bensen JT, Gehrig PA, Wu JM, Geller EJ
Source:
International Urogynecology Journal,
Published:
Feb 12 2016
Pages:
1409-14

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.
Show More

The Impact of Surgical Complications on Health-Related Quality of Life in Women Undergoing Gynecologic Oncology Procedures: A Prospective Longitudinal Cohort Study.
Author(s):
Doll KM, Barber EL, Bensen JT, Revilla MC, Snavely AC, Bennett AV, Reeve BB, Gehrig PA.
Source:
American Journal of Obstetrics and Gynecology,
Published:
April 27, 2016

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
Show More

The health-related quality of life journey of gynecologic oncology surgical patients: Implications for the incorporation of patient-reported outcomes into surgical quality metrics.
Author(s):
Doll KM, Barber EL, Bensen JT, Snavely AC, Gehrig PA.
Source:
Gynecologic Oncology,
Published:
May 2016
Pages:
329-35

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.
Show More

Who presents satisfied? Non-modifiable factors associated with patient satisfaction among gynecologic oncology clinic patients.
Author(s):
Barber EL, Bensen JT, Snavely AC, Gehrig PA, Doll KM.
Source:
Gynecologic Oncology,
Published:
August 2016
Pages:
299-303

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.
Show More

Endocrine therapy and urogenital outcomes among women with a breast cancer diagnosis.
Author(s):
Landi SN, Doll KM, Bensen JT, Hendrix L, Anders CK, Wu JM, Nichols HB.
Source:
Cancer Causes and Control,
Published:
Nov 27 2016
Pages:
1325-1332

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
Show More

Activities, Function, and Health-Related Quality of Life (HRQOL) of Older Adults with Cancer.
Author(s):
Pergolotti M, Deal AM, Williams GR, Bryant AL, Bensen JT, Muss HB, Reeve BB.
Source:
Journal of Geriatric Oncology,
Published:
Mar 2017

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
Show More

Preventing weight gain in African American breast cancer survivors using smart scales and activity trackers: a randomized controlled pilot study
Author(s):
Valle CG, Deal AM, Tate DF.
Source:
Journal of Cancer Survivorship,
Published:
February 2017
Pages:
133-148

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
Show More