Trial Information

Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer

OBJECTIVES:

- Characterize 3 separate types of patient-reported outcomes (quality of life [e.g.,
generic and disease-specific], functional outcomes [e.g., bowel and sexual function and
activities of daily living], and clinical symptoms [e.g., pain, fatigue]) in long-term
(5+ years) survivors of colon and rectal cancers in a large national sample recruited
from five National Surgical Adjuvant Breast and Bowel Project (NSABP) treatment trials.

- Explore the degree to which patient-reported outcomes are impacted by individual
characteristics (e.g., specific predisposing factors, enabling resources, and need), by
health behaviors (e.g., use of services for cancer-related and non-cancer-related
issues), and, when appropriate, by the specific treatments that were received.

- Examine patient-reported outcomes prior to randomization and treatment, 1 year after
treatment, and in long-term follow up > 5 years after diagnosis in patients with colon
cancer treated with adjuvant chemotherapy on protocols NSABP C-06 or NSABP C-07.

OUTLINE: This is a cohort, single-group, multicenter study.

Patients complete a one-time, computer-assisted telephone interview assessing their overall
quality of life (QOL), disease-specific QOL, function and symptoms (including pain and
fatigue), use of healthcare services, prevalence and severity of comorbidity, and
demographics.

PROJECTED ACCRUAL: A total of 1,167 patients will be accrued for this study.