Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT07164456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical functioning, QoL, and family health climate, compared to survivor-only and control groups.
Detailed Description:
Primary Objectives
• Determine the extent to which MVPA and overall diet quality have improved in Black PCa survivors and their caregivers in the family-centered intervention group, compared to those in the survivor-only and control groups at post-intervention.
Secondary Objectives
* Determine the extent to which, compared to those in the survivor-only and control groups, both survivors and caregivers in the family-centered group maintain the MVPA and high diet quality at the 6-month follow-up, and experience improved 6MWT, QoL, and family health climate at both post-intervention and 6-month follow-up.
* Identify mediators and moderators of the family-centered intervention.
• Determine the extent to which MVPA and overall diet quality have improved in Black PCa survivors and their caregivers in the family-centered intervention group, compared to those in the survivor-only and control groups at post-intervention.
Secondary Objectives
* Determine the extent to which, compared to those in the survivor-only and control groups, both survivors and caregivers in the family-centered group maintain the MVPA and high diet quality at the 6-month follow-up, and experience improved 6MWT, QoL, and family health climate at both post-intervention and 6-month follow-up.
* Identify mediators and moderators of the family-centered intervention.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-06570 | OTHER | NCI-CTRP Clinical Registry | View |