NCT00303875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
641

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Dec 2003

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2013

Enrollment Period

4.5 years

First QC Date

March 15, 2006

Last Update Submit

February 21, 2017

Conditions

Breast CancerColorectal CancerProstate Cancer

Keywords

recurrent prostate cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent colon cancerstage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerrecurrent rectal cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Quality of life as assessed by SF-36 at baseline and years 1 and 2 following study completion

    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

    one year

  • Dietary intake as assessed by 2-day dietary recalls at baseline and years 1 and 2 following study completion

    one year

  • Body weight status as assessed by body mass index at baseline and years 1 and 2 following study completion

    one year

  • Depression and/or anxiety as assessed by Hospital Anxiety Depression Scale at baseline and years 1 and 2 following study completion

    one year

  • +2 more secondary outcomes

Study Arms (2)

Wait-list control

NO INTERVENTION

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

Lifestyle counseling

EXPERIMENTAL

subjects randomized to receive diet \& exercise counseling for one year

Behavioral: behavioral dietary and exercise intervention

Interventions

behavioral dietary and exercise interventionBEHAVIORAL
Lifestyle counseling

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Veterans Affairs Medical Center - Durham

Durham, North Carolina, 27705, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Publications (10)

  • 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.

    PMID: 22614994RESULT

  • 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.

    PMID: 22709810RESULT

  • 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.

    PMID: 19637244RESULT

  • 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.

    PMID: 19436015RESULT

  • 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.

    PMID: 19117329RESULT

  • 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.

    PMID: 26512712RESULT

  • 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.

    PMID: 24648018RESULT

  • 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.

    PMID: 24389524RESULT

  • 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.

    PMID: 20122025RESULT

  • 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.

    PMID: 18792788RESULT

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsProstatic NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Wendy Demark-Wahnefried, PhD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2006

First Posted

March 17, 2006

Study Start

December 1, 2003

Primary Completion

June 1, 2008

Study Completion

May 1, 2009

Last Updated

February 23, 2017

Record last verified: 2013-02

Locations

US(2)