Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer

Breast Cancer Clinical Trial

Official title:

Project LEAD: Promoting Health Among Populations With Early Stage Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037024
• Other study ID #: Pro00009493
• Secondary ID: DUMC-1547-02-8R4
• Status: Completed
• Phase: N/A
• First received: May 13, 2002
• Last updated: February 21, 2017
• Start date: April 2002
• Est. completion date: October 2004

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• Compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer.

• Compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients.

• Compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.

• Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a personal trainer.

• Arm II: Patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention).

In both arms, counseling continues every 2 weeks for 6 months.

Patients are followed at 6 months.

PROJECTED ACCRUAL: A total of 420 patients (210 per arm) will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Depression
• Fatigue
• Malnutrition
• Prostate Cancer
• Prostatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Procedure:
• fatigue assessment and management

• nutritional support

• physical therapy

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (8)

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 t — View Citation

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. — View Citation

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 — View Citation

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):2 — 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

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, 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: — View Citation

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. Review. — View Citation