Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00303875
First received: March 15, 2006
Last updated: April 9, 2013
Last verified: February 2013
  Purpose

RATIONALE: Exercise and dietary counseling may improve physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.

PURPOSE: This randomized clinical trial is studying two different schedules of exercise and dietary counseling to compare how well they work in improving physical activity, nutrition, and quality of life in older long-term cancer survivors who are overweight.


Condition Intervention Phase
Breast Cancer
Colorectal Cancer
Prostate Cancer
Behavioral: behavioral dietary and exercise intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: RENEW: Reach Out to Enhance Wellness in Older Survivors

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.


Secondary Outcome Measures:
  • Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

  • Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

  • Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

  • Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

  • Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

  • Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

  • Stage of readiness for exercise and dietary change as assessed by the stage of change algorithms at baseline and years 1 and 2 following study completion [ Time Frame: one year ] [ Designated as safety issue: No ]
    one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.


Enrollment: 641
Study Start Date: December 2003
Study Completion Date: May 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait-list control
Wait-list control received diet & exercise counseling during year 2 as a courtesy
Experimental: Lifestyle counseling
subjects randomized to receive diet & exercise counseling for one year
Behavioral: behavioral dietary and exercise intervention

Detailed Description:

OBJECTIVES:

Primary

  • Compare the physical function over 1 year of overweight older long-term cancer survivors assigned to immediate vs delayed exercise and dietary counseling.

Secondary

  • Compare physical activity, saturated fat and vegetable and fruit intake, body mass index, depression, and general health and well being of experimental arm patients vs control arm patients.
  • Evaluate self-efficacy, social support, comorbidity, cancer-type, and gender as factors associated with program efficacy.
  • Determine the functional decline over a 2-year period in patients who undergo immediate vs delayed intervention.
  • Characterize the mathematical form, over a 2-year period, of physical functioning trajectories among older cancer survivors, including determining if the intervention effects are durable in those who receive the intervention initially and whether "catch-up" is possible in the delayed intervention arm.

OUTLINE: This is a randomized study. Patients are stratified according to cancer type (colorectal vs breast or prostate), sex, age (65-74 years vs 75 years and over), and race (white vs non-white). Patients are randomized to 1 of 2 intervention arms.

  • Arm I (immediate intervention): Patients receive a personalized notebook of diet and exercise information, exercise equipment, and logbooks to record food intake and exercise behaviors. Patients undergo 20-minute telephone discussions with a health counselor once weekly for 3 weeks, every 2 weeks for 2 months, and then monthly for up to 1 year for a total of 15 sessions. Patients also undergo a 5-minute telephone survey to assess health every 3 months.
  • Arm II (delayed intervention): Patients undergo intervention as in arm I after a 1-year waiting period.

After completion of study intervention, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 640 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosed colorectal, prostate, or female breast cancer

    • At least 5 years beyond date of diagnosis with no clinical evidence of progressive disease or second primaries
  • Body mass index ≥ 25 kg/m^2 and < 40 kg/m^2
  • Currently exercising < 150 minutes/week
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • No serious intercurrent medical condition or disability that could preclude study treatment, including any of the following:

    • Severe orthopedic condition or scheduled hip or knee replacement within the next 6 months
    • Paralysis
    • End-stage renal disease
    • Dementia
    • Unstable angina
    • Heart attack, congestive heart failure, or pulmonary condition that required oxygen or hospitalization within the past 6 months
  • Ability to read, write, and speak English

PRIOR CONCURRENT THERAPY:

  • No concurrent warfarin
  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: NCT00303875

Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Veterans Affairs Medical Center - Durham
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
Study Chair: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
  More Information

Additional Information:
Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00303875     History of Changes
Other Study ID Numbers: Pro00012963, DUMC-5477-03-12R0ER, DUMC-5477-04-12R1ER, CDR0000460231
Study First Received: March 15, 2006
Last Updated: April 9, 2013
Health Authority: United States: Federal Government

Keywords provided by Duke University:
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent colon cancer
stage I colon cancer
stage II colon cancer
stage III colon cancer
stage IV colon cancer
recurrent rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Colorectal Neoplasms
Breast Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014