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

March 15, 2006
April 9, 2013
December 2003
June 2008   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00303875 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
RENEW: Reach Out to Enhance Wellness in Older Survivors

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer
Behavioral: behavioral dietary and exercise intervention
  • 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
    Intervention: Behavioral: behavioral dietary and exercise intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
641
May 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00303875
Pro00012963, DUMC-5477-03-12R0ER, DUMC-5477-04-12R1ER, CDR0000460231
Yes
Duke University
Duke University
National Cancer Institute (NCI)
Study Chair: Wendy Demark-Wahnefried, PhD Duke Cancer Institute
Duke University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP