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Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
This study is ongoing, but not recruiting participants.
First Received: March 15, 2006   Last Updated: May 19, 2009   History of Changes
Sponsors and Collaborators: Duke University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303875
  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 intervention
Behavioral: exercise intervention
Other: preventative dietary intervention
Phase II

Study Type: Interventional
Study Design: Randomized
Official Title: RENEW: Reach Out to Enhance Wellness in Older Survivors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion [ Designated as safety issue: No ]
  • Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion [ Designated as safety issue: No ]
  • Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion [ Designated as safety issue: No ]
  • Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion [ Designated as safety issue: No ]
  • Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion [ Designated as safety issue: No ]
  • Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 640
Study Start Date: December 2003
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
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 University
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000460231, DUMC-5477-03-12R0ER, DUMC-5477-04-12R1ER
Study First Received: March 15, 2006
Last Updated: May 19, 2009
ClinicalTrials.gov Identifier: NCT00303875     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage I prostate cancer
stage II 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

Study placed in the following topic categories:
Digestive System Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Skin Diseases
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Quality of Life
Breast Neoplasms
Urogenital Neoplasms
Overweight
Genital Diseases, Male
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Breast Diseases

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

ClinicalTrials.gov processed this record on September 02, 2009