Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT03575832
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2018-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Watchful Living: A Lifestyle Intervention for Black and Hispanic Prostate Cancer Patients and Their Partners
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-08
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:
This pilot trial studies how well Watchful Living works in improving quality of life in participants with prostate cancer that has not spread to other parts of the body who are on active surveillance and their partners. A social support lifestyle intervention (called Watchful Living) may help African American prostate cancer participants and their partners improve their quality of life, physical activity, diet, and inflammation.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the feasibility of recruiting and implementing a lifestyle intervention for prostate cancer patients and their partners.
SECONDARY OBJECTIVES:
I. To evaluate the preliminary efficacy of a lifestyle intervention in improving diet, physical activity, physical fitness, partner's support, quality of life, and inflammation at the end of the study (month 6).
II. To conduct a process evaluation of the lifestyle intervention. III. Explore participants' satisfaction, likes/dislikes, strengths, weaknesses, and areas of improvement regarding the program.
OUTLINE:
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
I. To determine the feasibility of recruiting and implementing a lifestyle intervention for prostate cancer patients and their partners.
SECONDARY OBJECTIVES:
I. To evaluate the preliminary efficacy of a lifestyle intervention in improving diet, physical activity, physical fitness, partner's support, quality of life, and inflammation at the end of the study (month 6).
II. To conduct a process evaluation of the lifestyle intervention. III. Explore participants' satisfaction, likes/dislikes, strengths, weaknesses, and areas of improvement regarding the program.
OUTLINE:
Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.
Study Oversight
Has Oversight DMC:
False
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?: