For Researchers - Recruitment and Enrollment
Eligibility
In order to be eligible to participate in the HR/CSC, a person must fulfill all the following requirements:
- Have an appointment at UNC Health Care in an oncology clinic
- Be 18 years of age or older
- Have a North Carolina mailing address
- Speak English or Spanish
Patients are not eligible for inclusion in the cohort if they have any concurrent medical condition or personal situation that would render the patient unable to provide informed consent or participate in the HR/CSC.Recruitment Process
At the time of patient appointment scheduling, initial physician referral and demographic information is collected and entered into the North Carolina Cancer Hospital (NCCH) electronic scheduling system. These data are made available to the HR/CSC for determination of eligibility. Eligible patients are approached for enrollment during his or her visit to the NCCH.
[ A detailed HR/CSC Recruitment and Enrollment Protocol is available upon request by contacting HR/CSC cscresearchers@med.unc.edu. ].
Informed Consent Process
All participants provide informed consent in either English or Spanish prior to participation. Eligible patients typically watch a video unchealthregistry.org/informed-consent that describes participation in the HR/CSC and informed consent and HIPAA documents. Research Assistants (RAs) discuss the consent video with patients and answer questions.
Patients that would like to participate in the UNC Health Registry/Cancer Survivorship Cohort (HR/CSC) sign Informed Consent and HIPAA Documents electronically.
To view the UNC HR/CSC Consent and HIPAA documents, click here.
The signed forms are stored securely in HR/CSC records and paper copies of the informed consent and HIPAA documents are given to the participants. In some clinic situations, using the video consent is not always feasible and in these situations the informed consent process is done by the Research Assistants by reviewing the paper consent documents with patients.
Enrolled participants agree to the following (click to view subject-specific pages):
- Interview questionnaires - Interviews are conducted of all HR/CSC participants within a couple of weeks after enrollment. The Baseline Interview includes a general questionnaire that is asked across all cancer types and a cancer-specific questionnaire.
- Medical records – Medical records data for HR/CSC participant includes clinical information abstracted by the UNC Tumor Registry and supplemental data abstracted by HR/CSC staff.
- Blood collection and banking - HR/CSC participants have blood samples drawn and the sample is processed by the Biospecimen Processing Facility (BS) to serum, plasma and DNA. The serum, plasma and DNA are banked for future research.
- Tissue procurement and banking - Leftover tumor tissue samples taken at the time of surgery are snap frozen, paraffin embedded and banked for future research by the Tissue Procurement Facility (TPF).
- Other clinical biospecimens - Any biospecimen collected as part of routine health care for a HR/CSC participant may be banked and used for future research.
- Annual follow-up - HR/CSC participants agree to annual follow-up contact for interviews and medical records abstraction.
- Recontact - HR/CSC participants agree to allow HR/CSC staff to contact them about participation in future studies.
Enrollment Graph
To view the participant enrollment graph, click here.
Cumulative number of HR/CSC participants enrolled by month since HR/CSC enrollment began in 2010.
Demographics
Summary demographics include race and age for enrolled participants. To view the demographics of enrolled participants, click here.
