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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Fatigue Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Long-term Effects Secondary to Cancer Therapy in Adults Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Psychosocial Effects of Cancer and Its Treatment Rectal Diseases Rectal Neoplasms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Aurora Presbyterian Hospital, Aurora, Colorado, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telephone interview

Other

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)

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

NSABP Foundation Inc

Network

Collaborators

National Cancer Institute (NCI)
University of California, Los Angeles

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Dec 13, 2006
Registry last updated: Dec 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed