NCT00037024

Brief Summary

RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

1 active site

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

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

February 23, 2017

Status Verified

November 1, 2012

Enrollment Period

1.8 years

First QC Date

May 13, 2002

Last Update Submit

February 21, 2017

Conditions

Breast CancerDepressionFatigueMalnutritionProstate CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

stage I breast cancerstage II breast cancerstage I prostate cancerstage II B prostate cancerstage II A prostate cancermale breast cancerfatiguemalnutritionpsychosocial effects of cancer and its treatmentdepression

Interventions

fatigue assessment and managementPROCEDURE
nutritional supportPROCEDURE
physical therapyPROCEDURE
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age65 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of early-stage breast or prostate cancer within the past 18 months * Dietary and physical activity habits and baseline functional status that places patient at risk * Potentially able to increase physical activity and to follow a low-fat, plant-based diet * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 65 and over Sex: * Male or female Menopausal status: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Able to speak and write English * No other malignancy within the past 5 years except nonmelanoma skin cancer * No other illness or condition that would preclude adherence to a plant-based diet or exercise PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Publications (8)

  • Demark-Wahnefried W, Morey MC, Clipp EC, Pieper CF, Snyder DC, Sloane R, Cohen HJ. Leading the Way in Exercise and Diet (Project LEAD): intervening to improve function among older breast and prostate cancer survivors. Control Clin Trials. 2003 Apr;24(2):206-23. doi: 10.1016/s0197-2456(02)00266-0.

    PMID: 12689742RESULT

  • Demark-Wahnefried W, Clipp EC, Morey MC, Pieper CF, Sloane R, Snyder DC, Cohen HJ. Physical function and associations with diet and exercise: Results of a cross-sectional survey among elders with breast or prostate cancer. Int J Behav Nutr Phys Act. 2004 Oct 29;1(1):16. doi: 10.1186/1479-5868-1-16.

    PMID: 15516261RESULT

  • Demark-Wahnefried W, Clipp EC, Morey MC, Pieper CF, Sloane R, Snyder DC, Cohen HJ. Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD. J Clin Oncol. 2006 Jul 20;24(21):3465-73. doi: 10.1200/JCO.2006.05.7224.

    PMID: 16849763RESULT

  • Stull VB, Snyder DC, Demark-Wahnefried W. Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. J Nutr. 2007 Jan;137(1 Suppl):243S-248S. doi: 10.1093/jn/137.1.243S.

    PMID: 17182834RESULT

  • Clutter Snyder D, Sloane R, Haines PS, Miller P, Clipp EC, Morey MC, Pieper C, Cohen H, Demark-Wahnefried W. The Diet Quality Index-Revised: a tool to promote and evaluate dietary change among older cancer survivors enrolled in a home-based intervention trial. J Am Diet Assoc. 2007 Sep;107(9):1519-29. doi: 10.1016/j.jada.2007.06.014.

    PMID: 17761229RESULT

  • Morey MC, Sloane R, Pieper CF, Peterson MJ, Pearson MP, Ekelund CC, Crowley GM, Demark-Wahnefried W, Snyder DC, Clipp EC, Cohen HJ. Effect of physical activity guidelines on physical function in older adults. J Am Geriatr Soc. 2008 Oct;56(10):1873-8. doi: 10.1111/j.1532-5415.2008.01937.x. Epub 2008 Sep 17.

    PMID: 18800990RESULT

  • 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

  • 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

MeSH Terms

Conditions

Breast NeoplasmsDepressionFatigueMalnutritionProstatic NeoplasmsBreast Neoplasms, Male

Interventions

TherapeuticsNutritional SupportPhysical Therapy ModalitiesPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition TherapyRehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Wendy Demark-Wahnefried, PhD

    Duke Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Primary Completion

February 1, 2004

Study Completion

October 1, 2004

Last Updated

February 23, 2017

Record last verified: 2012-11

Locations

US(1)