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

Breast Cancer Clinical Trial

Official title:

RENEW: Reach Out to Enhance Wellness in Older Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303875
• Other study ID #: Pro00012963
• Secondary ID: DUMC-5477-03-12R
• Status: Completed
• Phase: Phase 2
• First received: March 15, 2006
• Last updated: February 21, 2017
• Start date: December 2003
• Est. completion date: May 2009

Study information

• Verified date: February 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: May 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• behavioral dietary and exercise intervention

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Veterans Affairs Medical Center - Durham	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View 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:S262-4. doi: 10.1111/j.1532-5415.2009.02507.x. Review. — View 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 phy — View 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. — View 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 — View 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.2968 — View 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 — View 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: — View 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 ex — View 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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year
Secondary	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.	one year
Secondary	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.	one year
Secondary	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.	one year
Secondary	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.	one year
Secondary	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.	one year
Secondary	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.	one year
Secondary	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.	one year