Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers

Pain Clinical Trial

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

Status Completed

Clinical Trial Summary

RATIONALE: Learning about quality of life, symptoms, and health behaviors in colorectal cancer survivors may help to determine the long-term effects of colon and rectal cancer treatments and may help to improve the quality of life for future cancer survivors.

PURPOSE: This clinical trial is looking at patient-reported outcomes in long-term survivors of colon and rectal cancers.

Clinical Trial Description

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. ;

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Colorectal Cancer
• Fatigue
• Long-term Effects Secondary to Cancer Therapy in Adults
• Pain
• Psychosocial Effects of Cancer and Its Treatment

• NCT number: NCT00410579
• Study type: Observational
• Source: NSABP Foundation Inc
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Completion date: February 2009