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

February 21, 2017 updated by: Duke University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

641

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Veterans Affairs Medical Center - Durham
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 120 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
Time Frame: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
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
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion
Time Frame: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion
Time Frame: one year
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
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
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
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
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year
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
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Wendy Demark-Wahnefried, PhD, Duke Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 15, 2006

First Submitted That Met QC Criteria

March 15, 2006

First Posted (Estimate)

March 17, 2006

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00012963
  • DUMC-5477-03-12R0ER
  • DUMC-5477-04-12R1ER
  • CDR0000460231 (Other Identifier: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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