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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. Identifier: NCT03575832
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : July 3, 2018
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Prostate Cancer Patients + Partners Behavioral: Questionnaires

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.

Primary Outcome Measures :
  1. 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.

  2. 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%).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Self-identify as black or African American (patient)
  2. Be greater than 18 years of age (patient and spouse or intimate partner)
  3. Have clinically localized prostate cancer diagnosed within 6 to 24 months prior to study enrollment (patient)
  4. Be eligible to undergo active surveillance or be undergoing active surveillance (patient)
  5. Enroll with a spouse or intimate partner (patient)
  6. Be overweight or obese based on body mass index greater than or equal to 25 (patient)
  7. Be ready and able to be physically active, as determined by a physician (letter from a physician or nurse practitioner) (patient)
  8. Not participate in another physical activity, diet, or lifestyle program (patient)
  9. Have a valid home address and telephone number (patient)
  10. Enroll with a spouse or intimate partner with prostate cancer on active surveillance (spouse or intimate partner)

Exclusion Criteria:

  1. Have an active noncutaneous malignancy at any site (patient)
  2. Had prior radiation therapy for treatment of the primary tumor (patient)
  3. Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period (patient)
  4. Are enrolled in another active surveillance protocol (patient)
  5. Participated in formative focus groups for this study (patient and spouse or intimate partner)

Information from the National Library of Medicine

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 identifier (NCT number): NCT03575832

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Contact: Lorna H. McNeill, PHD, MPH 713-563-1103

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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
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Principal Investigator: Lorna H. McNeill, PHD, MPH M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT03575832     History of Changes
Other Study ID Numbers: 2017-0556
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Diseases of male genital organs
Prostate Cancer
Physical Fitness Test
Blinded Accelerometer
Home-Based Physical Activity Program
Telephone Coaching Calls
Nutrition Counseling
Focus Group

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases