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

Completed

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

• Registration Number: NCT00410579
• Lead Sponsor: NSABP Foundation Inc

Brief 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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-11
• Study First Submitted QC: 2006-12-11
• Study First Posted: 2006-12-13
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-15
• Last Update Posted: 2010-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 744

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Types of patient-reported outcomes	After all telephone interviews are completed	Survey battery for quality of life, functional outcomes, and clinical symptoms from patients from all 5 trails
Degree to which patient-reported outcomes are impacted by individual characteristics, health behaviors, and when appropriate specific treatments that were received	After all telephone interviews are completed	Long Term Mental and Physical Component Scales, EORTC-CR 38, Individual Characteristics and Health Behaviors, treatment information
Comparison of patient-reported outcomes prior to randomization, 1 year after completion of study treatment, and in long-term follow up > 5 years after diagnosis in patients treated in NSABP C-06 or NSABP C-07 trials	After all telephone interviews are completed	Four generic subscales of FACT-C and the colorectal cancer subscale, total score of symptoms distress scale, SF-12 Vitality subscale and health rating scale; NTX-R

Trial Locations

Locations (199)

Aurora Presbyterian Hospital; 🇺🇸 Aurora, Colorado, United States

Boulder Community Hospital; 🇺🇸 Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

St. Anthony Central Hospital; 🇺🇸 Denver, Colorado, United States

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States

St. Joseph Hospital; 🇺🇸 Denver, Colorado, United States

Rose Medical Center; 🇺🇸 Denver, Colorado, United States

CCOP - Colorado Cancer Research Program; 🇺🇸 Denver, Colorado, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

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