Watchful Living: A Lifestyle Intervention for Black Prostate Cancer Patients on Active Surveillance and Their Partners
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03575832|
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : July 3, 2018
The goal of this study is to learn if a social support lifestyle intervention (called Watchful Living) can help African American prostate cancer patients and their partners improve their quality of life, physical activity, diet, and inflammation.
This is an investigational study.
Up to 80 participants (40 patients and their partners) will be enrolled in this part of the study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Diseases of Male Genital Organs Prostate Cancer||Behavioral: Questionnaires Behavioral: Physical Fitness Test Device: Blinded Accelerometer Behavioral: Home-Based Physical Activity Program Behavioral: Telephone Coaching Calls Behavioral: Nutrition Counseling Behavioral: Focus Group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Watchful Living: A Lifestyle Intervention for Black Prostate Cancer Patients on Active Surveillance and Their Partners|
|Actual Study Start Date :||January 25, 2018|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
|Experimental: Prostate Cancer Patients + Partners||
Computer-based questionnaire completed at baseline, 3 months, and at 6 months.
The questionnaire should take 45 minutes to complete.
Other Name: Surveys
Behavioral: Physical Fitness Test
Physical fitness test completed at baseline. and at month 6.
Device: Blinded Accelerometer
Participants given a blinded accelerometer at baseline 3 months, and 6 months that is worn for 7 days.
Behavioral: Home-Based Physical Activity Program
During baseline study visit, participants receive an exercise plan and printed materials, which includes instructions for walking (or other moderate-intensity activities if walking is difficult). These are activities that can be done at home.
Behavioral: Telephone Coaching Calls
After baseline visit, participants receive 10 telephone coaching calls lasting about 45-60 minutes each. Coaching calls occur every week during Month 1, every 2 weeks during Month 2, and every month during Months 3-6.
Behavioral: Nutrition Counseling
Participants complete 2 nutrition counseling sessions with a registered dietitian. First session occurs in-person at baseline visit. Second session occurs before Month 3 over the phone.
Behavioral: Focus Group
Participants take part in a focus group about two months after the Month 6 visit. This focus group may last up to 2 hours.
- Feasibility of Recruiting and Implementing a Lifestyle Intervention During Active Surveillance for Prostate Cancer Patients and Their Partners [ Time Frame: 6 months ]Feasibility achieved if 1) >/=80% of eligible participants enroll in the study and >/=80% participants complete follow-up assessments at months 3 and 6.
- Average Intervention Adherence Rate of a Lifestyle Intervention During Active Surveillance for Prostate Cancer Patients and Their Partners [ Time Frame: 6 months ]Average intervention adherence rate >/= 0.7 (average proportion of intervention sessions (e.g. coaching calls and nutrition sessions) completed by both the patient and partner >/= 70%).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575832
|Contact: Lorna H. McNeill, PHD, MPH||713-563-1103||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Principal Investigator:||Lorna H. McNeill, PHD, MPH||M.D. Anderson Cancer Center|