Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044980
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2002-09-06
Brief Title:
Diet and Exercise-Based Counseling Program Compared With a Standard Counseling Program in Patients With Early-Stage Prostate Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Fresh Start Promoting Health in Prostate Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE An individualized computer-designed health program may promote changes in diet and physical activity and may improve quality of life in patients who have early-stage prostate cancer
PURPOSE Randomized clinical trial to compare the effectiveness of an individualized computer-designed diet and exercise-based counseling program with that of a standard counseling program in promoting health in patients who have early-stage prostate cancer
PURPOSE Randomized clinical trial to compare the effectiveness of an individualized computer-designed diet and exercise-based counseling program with that of a standard counseling program in promoting health in patients who have early-stage prostate cancer
Detailed Description:
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 8103 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
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 8103 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000069500 | None | None | None |
| DUMC-1306-04-7R3ER | None | None | None |
| DUMC-1306-01-7R2ER | None | None | None |
| NCI-H02-0090 | None | None | None |