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

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Information provided by:
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT00410579
First received: December 11, 2006
Last updated: December 15, 2010
Last verified: December 2010
  Purpose

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 Intervention
Colorectal Cancer
Fatigue
Long-term Effects Secondary to Cancer Therapy in Adults
Pain
Psychosocial Effects of Cancer and Its Treatment
Other: Telephone interview

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer

Resource links provided by NLM:


Further study details as provided by NSABP Foundation Inc:

Primary Outcome Measures:
  • Types of patient-reported outcomes [ Time Frame: After all telephone interviews are completed ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 744
Study Start Date: November 2006
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410579

  Show 200 Study Locations
Sponsors and Collaborators
NSABP Foundation Inc
University of California, Los Angeles
Investigators
Study Chair: Norman Wolmark, MD NSABP Foundation Inc
  More Information

Additional Information:
Publications:
Kunitake H, Zheng P, Yothers G, et al.: Routine preventive care and cancer surveillance in long-term survivors (LTS) of colorectal cancer: results from NSABP Protocol LTS-01. [Abstract] J Clin Oncol 27 (Suppl 15): A-6500, 2009.
Yothers G, Land SR, Ganz PA, et al.: Neurotoxicity (NT) in colon cancer (CC) survivors from NSABP Protocol C-07 comparing 5-FU + leucovorin (FULV) with the same regimen + oxaliplatin (FLOX): preliminary results from NSABP protocol LTS-01. [Abstract] J Clin Oncol 26 (Suppl 15): A-9575, 2008.

Responsible Party: Norman Wolmark, MD, NSABP Foundation, Inc.
ClinicalTrials.gov Identifier: NCT00410579     History of Changes
Other Study ID Numbers: NSABP LTS-01, CDR0000494640
Study First Received: December 11, 2006
Last Updated: December 15, 2010
Health Authority: United States: Federal Government
United States: Instutional Review Board

Keywords provided by NSABP Foundation Inc:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Fatigue
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014