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Fresh Start: Promoting Health in Prostate Cancer Survivors


N/A
18 Years
N/A
Not Enrolling
Male
Malnutrition, Prostate Cancer

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Trial Information

Fresh Start: Promoting Health in Prostate Cancer Survivors


OBJECTIVES:

- Compare the effectiveness of a computer-tailored, correspondence course vs standardized
materials in promoting changes in diet and physical activity (PA) behaviors in patients
with early stage prostate or breast (closed to accrual as of 8/1/03) cancer who
currently do not practice goal behavior in at least 2 of the following 3 areas:
performance of moderate PA for at least 150 minutes per week; consumption of at least 5
servings of vegetables or fruit daily; or consumption of a diet with less than 30% fat
(with less than 10% of kilocalories from either saturates or polyunsaturates).

- Compare the health and quality of life of patients treated with these interventions.

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

- Arm I: Patients participate in a computer-tailored, correspondence course comprising
personalized diet and exercise intervention and other health information over a
10-month period.

- Arm II: Patients receive usual care comprising standardized print materials related to
diet, exercise, cancer, and other pertinent health issues over a 10-month period.

In both arms, diet and exercise behavior, quality of life, co-morbidity status, depression,
social support, worry, self efficacy, and coping style are assessed during phone interviews
conducted at baseline, after completion of 10 months of study intervention, and then at 1
year. Intervention usefulness is assessed after completion of 10 months of study
intervention.

Patients in both arms who live within a 1-hour drive from Duke University Medical Center may
undergo blood draw to test for substances related to fruit and vegetable intake and
measurement of height and weight. Patients may also be asked to wear a pedometer for a
1-week period.

PROJECTED ACCRUAL: A total of 530 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosed with early stage prostate or breast (closed to accrual as of 8/1/03) cancer
within the past 9 months

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Breast cancer (closed to accrual as of 8/1/03) patients must be female

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Other

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- Able to speak and write in English

- Performs insufficient exercise

- Maintains a high-fat, low-vegetable, low-fruit diet

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized

Principal Investigator

Wendy Demark-Wahnefried, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

Pro00008521 CDR0000069500

NCT ID:

NCT00044980

Start Date:

July 2002

Completion Date:

December 2006

Related Keywords:

  • Malnutrition
  • Prostate Cancer
  • malnutrition
  • stage I prostate cancer
  • stage II B prostate cancer
  • stage II A prostate cancer
  • Prostatic Neoplasms
  • Malnutrition

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710