NCT00410579

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 744 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Telephone interview	Telephone interview to assess generic health status, quality of life, comorbidity, impact of cancer, use of medical services, health rating, pain, fatigue, activities of daily living, demographics, functional well-being(C-06 only), and neurotoxicity (C-07 only)

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2006-12-13
• Last updated: 2010-12-17

Locations

200 sites across 1 country: United States