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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00410579
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : December 17, 2010
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, Los Angeles
Information provided by:
NSABP Foundation Inc

Tracking Information
First Submitted Date December 11, 2006
First Posted Date December 13, 2006
Last Update Posted Date December 17, 2010
Study Start Date November 2006
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2010)
  • 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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers
Official Title Patient Reported Outcomes in Long Term Survivors With Colon and Rectal Cancer
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 Type Observational
Study Design Observational Model: Cohort
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Colorectal Cancer
  • Fatigue
  • Long-term Effects Secondary to Cancer Therapy in Adults
  • Pain
  • Psychosocial Effects of Cancer and Its Treatment
Intervention 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)
Study Groups/Cohorts 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
Intervention: Other: Telephone interview
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2010)
744
Original Enrollment
 (submitted: December 11, 2006)
1167
Actual Study Completion Date February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00410579
Other Study ID Numbers NSABP LTS-01
CDR0000494640 ( Other Identifier: NCI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Norman Wolmark, MD, NSABP Foundation, Inc.
Study Sponsor NSABP Foundation Inc
Collaborators
  • National Cancer Institute (NCI)
  • University of California, Los Angeles
Investigators
Study Chair: Norman Wolmark, MD NSABP Foundation Inc
PRS Account NSABP Foundation Inc
Verification Date December 2010