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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of California, Los Angeles
Information provided by:
NSABP Foundation Inc

Study Description
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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.


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

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 Design
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Study Type : Observational
Actual Enrollment : 744 participants
Observational Model: Cohort
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
Groups and Cohorts
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Group/Cohort Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
NSABP Foundation Inc
National Cancer Institute (NCI)
University of California, Los Angeles
Investigators
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Study Chair: Norman Wolmark, MD NSABP Foundation Inc
More Information
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Publications of Results:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Norman Wolmark, MD, NSABP Foundation, Inc.
ClinicalTrials.gov Identifier: NCT00410579    
Other Study ID Numbers: NSABP LTS-01
CDR0000494640 ( Other Identifier: NCI )
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: December 2010
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:
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Rectal Neoplasms
Fatigue
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases