Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037024
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2002-05-13
Brief Title:
Study of Health Promotion in Patients With Early-Stage Breast or Prostate Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Project LEAD Promoting Health Among Populations With Early Stage Cancers
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 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
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
Detailed 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 eg 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
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 eg 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
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 |
|---|---|---|---|
| CDR0000069355 | None | None | None |
| DUMC-1547-02-8R4ER | None | None | None |
| DUMC-1547-00-8R2ER | None | None | None |
| NCI-H02-0088 | None | None | None |