Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers
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|ClinicalTrials.gov Identifier: NCT00410579|
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : December 17, 2010
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.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Fatigue Long-term Effects Secondary to Cancer Therapy in Adults Pain Psychosocial Effects of Cancer and Its Treatment||Other: Telephone interview|
- 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 Type :||Observational|
|Actual Enrollment :||744 participants|
|Official Title:||Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07
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
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)
- Types of patient-reported outcomes [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410579
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|Study Chair:||Norman Wolmark, MD||NSABP Foundation Inc|