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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: Telephone interview


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Prior diagnosis of colon or rectal cancer At least 5 years since participated in 1 of the following clinical trials: NSABP-R-02 NSABP-R-03 NSABP-C-05 NSABP-C-06 NSABP-C-07 PATIENT CHARACTERISTICS: Able to speak English PRIOR CONCURRENT THERAPY: As per participation requirements of previous NSABP treatment trials
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07<br>Study population to be interviewed comprises patients who were treated at least 5 years ago for colon or rectal cancer in NSABP trials R-02, R-03, C-05, C-06 or C-07 | Other: Telephone interview<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Types of patient-reported outcomes | Survey battery for quality of life, functional outcomes, and clinical symptoms from patients from all 5 trails | After all telephone interviews are completed | 
| Degree to which patient-reported outcomes are impacted by individual characteristics, health behaviors, and when appropriate specific treatments that were received | Long Term Mental and Physical Component Scales, EORTC-CR 38, Individual Characteristics and Health Behaviors, treatment information | After all telephone interviews are completed | 
| 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 | 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 | After all telephone interviews are completed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, fatigue, long-term effects secondary to cancer therapy in adults, psychosocial effects of cancer and its treatment, stage II rectal cancer, stage III rectal cancer, stage II colon cancer, stage III colon cancer, adenocarcinoma of the colon