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NCT00410579 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2010-12-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
sampling Method
NON_PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
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
Treatment arms and interventions
arm Groups
  1. description
    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 Names
    1. Other: Telephone interview
    label
    Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07
interventions
  1. arm Group Labels
    1. Patients treated in NSABP R-02, R-03, C-05, C-06 or C-07
    description
    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)
    name
    Telephone interview
    type
    OTHER
Study design
observational Model
COHORT
Enrollment
count
744
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Survey battery for quality of life, functional outcomes, and clinical symptoms from patients from all 5 trails
    measure
    Types of patient-reported outcomes
    time Frame
    After all telephone interviews are completed
  2. description
    Long Term Mental and Physical Component Scales, EORTC-CR 38, Individual Characteristics and Health Behaviors, treatment information
    measure
    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
  3. description
    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
    measure
    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
Full study description
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.
Source references
references
  1. citation
    Kunitake H, Zheng P, Yothers G, Land SR, Fehrenbacher L, Giguere JK, Wickerham DL, Ganz PA, Ko CY. Routine preventive care and cancer surveillance in long-term survivors of colorectal cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol LTS-01. J Clin Oncol. 2010 Dec 20;28(36):5274-9. doi: 10.1200/JCO.2010.30.1903. Epub 2010 Nov 15.
    pmid
    21079140
    type
    RESULT
  2. citation
    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.
    type
    RESULT
  3. citation
    Kunitake H, Russell MM, Zheng P, Yothers G, Land SR, Petersen L, Fehrenbacher L, Giguere JK, Wickerham DL, Ko CY, Ganz PA. Quality of life and symptoms in long-term survivors of colorectal cancer: results from NSABP protocol LTS-01. J Cancer Surviv. 2017 Feb;11(1):111-118. doi: 10.1007/s11764-016-0567-y. Epub 2016 Aug 25.
    pmid
    27562475
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        Cancer Study Group trial.[<a href="#cit/section_4.17">17</a>]</li><li>National Surgical Adjuvant Breast and Bowel Project R-03 trial <a href="/clinicaltrials/NCT00410579">NSABP R-03</a> (NCT00410579).[<a href="#cit/section_4.18">18</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810017&amp;version=HealthProfessional&amp;lang
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        href="#cit/section_4.17">17</a>]</li><li>National Surgical Adjuvant Breast and Bowel Project R-03 trial <a href="/clinicaltrials/NCT00410579">NSABP R-03</a> (NCT00410579).[<a href="#cit/section_4.18">18</a>][<a href="/Common/PopUps/popDefinition.aspx?id=810017&amp;version=HealthProfessional&amp;language=English" onclick="javasc
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        mpared surgery alone with surgery followed by chemotherapy or radiation therapy.[<a href="#cit/section_4.33">33</a>] Subsequently, the <a href="/clinicaltrials/NCT00410579">NSABP-R-02</a> study (NCT00410579), addressed whether adding postoperative radiation therapy to chemotherapy would enhance the survival advantage reported in
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        ollowed by chemotherapy or radiation therapy.[<a href="#cit/section_4.33">33</a>] Subsequently, the <a href="/clinicaltrials/NCT00410579">NSABP-R-02</a> study (NCT00410579), addressed whether adding postoperative radiation therapy to chemotherapy would enhance the survival advantage reported in R-01.[<a href="#cit/section_4.34">
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        r N1 disease. A similar number of patients were possibly overtreated in the preoperative treatment group.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00410579">NSABP R-03</a> trial (NCT00410579) similarly compared preoperative versus postoperative chemoradiation therapy for patients with clinically staged T3 or T4 or
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      6. context exact
        patients were possibly overtreated in the preoperative treatment group.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00410579">NSABP R-03</a> trial (NCT00410579) similarly compared preoperative versus postoperative chemoradiation therapy for patients with clinically staged T3 or T4 or lymph node-positive rectal cancer.
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      source title
      Rectal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Independent clinical review pending · Not medical advice