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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

Primary Purpose

Breast Cancer, Colorectal Cancer, Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
behavioral dietary and exercise intervention
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring 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

Eligibility Criteria

65 Years - 120 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans Affairs Medical Center - Durham
  • Duke Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Wait-list control

Lifestyle counseling

Arm Description

Wait-list control received diet & exercise counseling during year 2 as a courtesy

subjects randomized to receive diet & exercise counseling for one year

Outcomes

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
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
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
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
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
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
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
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
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.

Full Information

First Posted
March 15, 2006
Last Updated
February 21, 2017
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00303875
Brief Title
Exercise and Dietary Counseling in Improving Physical Activity, Nutrition, and Quality of Life in Older Long-Term Cancer Survivors Who Are Overweight
Official Title
RENEW: Reach Out to Enhance Wellness in Older Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Prostate Cancer
Keywords
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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
641 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Wait-list control received diet & exercise counseling during year 2 as a courtesy
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
subjects randomized to receive diet & exercise counseling for one year
Intervention Type
Behavioral
Intervention Name(s)
behavioral dietary and exercise intervention
Primary Outcome Measure Information:
Title
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
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year
Title
Physical activity as assessed by Community Healthy Activities Model Program for Seniors (CHAMPS) at baseline and years 1 and 2 following study completion
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year
Title
Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year
Title
Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year
Title
Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year
Title
Self-efficacy for exercise and dietary change assessed by self-efficacy algorithms at baseline and years 1 and 2 following study completion
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year
Title
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
Description
one year for intervention subjects - in year two, wait listed controls received intervention and the intervention subjects were followed.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Demark-Wahnefried, PhD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Veterans Affairs Medical Center - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22614994
Citation
Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Miller PE, Hartman TJ, Cohen HJ. Reach out to enhance wellness home-based diet-exercise intervention promotes reproducible and sustainable long-term improvements in health behaviors, body weight, and physical functioning in older, overweight/obese cancer survivors. J Clin Oncol. 2012 Jul 1;30(19):2354-61. doi: 10.1200/JCO.2011.40.0895. Epub 2012 May 21.
Results Reference
result
PubMed Identifier
22709810
Citation
Miller PE, Morey MC, Hartman TJ, Snyder DC, Sloane R, Cohen HJ, Demark-Wahnefried W. Dietary patterns differ between urban and rural older, long-term survivors of breast, prostate, and colorectal cancer and are associated with body mass index. J Acad Nutr Diet. 2012 Jun;112(6):824-31, 831.e1. doi: 10.1016/j.jand.2012.02.021.
Results Reference
result
PubMed Identifier
19637244
Citation
Mosher CE, Sloane R, Morey MC, Snyder DC, Cohen HJ, Miller PE, Demark-Wahnefried W. Associations between lifestyle factors and quality of life among older long-term breast, prostate, and colorectal cancer survivors. Cancer. 2009 Sep 1;115(17):4001-9. doi: 10.1002/cncr.24436.
Results Reference
result
PubMed Identifier
19436015
Citation
Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.
Results Reference
result
PubMed Identifier
19117329
Citation
Snyder DC, Morey MC, Sloane R, Stull V, Cohen HJ, Peterson B, Pieper C, Hartman TJ, Miller PE, Mitchell DC, Demark-Wahnefried W. Reach out to ENhancE Wellness in Older Cancer Survivors (RENEW): design, methods and recruitment challenges of a home-based exercise and diet intervention to improve physical function among long-term survivors of breast, prostate, and colorectal cancer. Psychooncology. 2009 Apr;18(4):429-39. doi: 10.1002/pon.1491.
Results Reference
result
PubMed Identifier
26512712
Citation
Morey MC, Blair CK, Sloane R, Cohen HJ, Snyder DC, Demark-Wahnefried W. Group trajectory analysis helps to identify older cancer survivors who benefit from distance-based lifestyle interventions. Cancer. 2015 Dec 15;121(24):4433-40. doi: 10.1002/cncr.29684. Epub 2015 Oct 29.
Results Reference
result
PubMed Identifier
24648018
Citation
Winger JG, Mosher CE, Rand KL, Morey MC, Snyder DC, Demark-Wahnefried W. Diet and exercise intervention adherence and health-related outcomes among older long-term breast, prostate, and colorectal cancer survivors. Ann Behav Med. 2014 Oct;48(2):235-45. doi: 10.1007/s12160-014-9598-7.
Results Reference
result
PubMed Identifier
24389524
Citation
Blair CK, Morey MC, Desmond RA, Cohen HJ, Sloane R, Snyder DC, Demark-Wahnefried W. Light-intensity activity attenuates functional decline in older cancer survivors. Med Sci Sports Exerc. 2014 Jul;46(7):1375-83. doi: 10.1249/MSS.0000000000000241.
Results Reference
result
PubMed Identifier
20122025
Citation
Demark-Wahnefried W, Morey MC, Sloane R, Snyder DC, Cohen HJ. Promoting healthy lifestyles in older cancer survivors to improve health and preserve function. J Am Geriatr Soc. 2009 Nov;57 Suppl 2(Suppl 2):S262-4. doi: 10.1111/j.1532-5415.2009.02507.x.
Results Reference
result
PubMed Identifier
18792788
Citation
Miller P, Demark-Wahnefried W, Snyder DC, Sloane R, Morey MC, Cohen H, Kranz S, Mitchell DC, Hartman TJ. Dietary supplement use among elderly, long-term cancer survivors. J Cancer Surviv. 2008 Sep;2(3):138-48. doi: 10.1007/s11764-008-0060-3. Epub 2008 Jul 11.
Results Reference
result

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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

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