Houston, Texas 77030


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Self-identify as black or African American or Hispanic (patient) - Have 0-III stage prostate cancer (patient) - If treated, have completed therapy (e.g., surgery, chemo and/or radiation) (patient) - Enroll with a spouse or intimate partner (patient) - Do not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week) (patient and spouse or intimate partner) - Be ready and able to be physically active, as determined by a physician (letter from a physician or nurse practitioner) (patient and spouse or intimate partner) - Not participate in another physical activity, diet, or lifestyle program (patient) - Have a valid home address and telephone number (patient) - Internet access at home or other location (e.g., work, church, library, community center, etc.) (spouse or intimate partner) - Patients on active surveillance will be included Exclusion Criteria: - They have an active noncutaneous malignancy at any site (patient) - Had prior radiation therapy for treatment of the primary tumor (patient) - Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period (patient) - Are enrolled in another active surveillance protocol (patient) - Participated in formative focus groups for this study (patient and spouse or intimate partner)


NCT ID:

NCT03575832


Primary Contact:

Principal Investigator
Lorna McNeill
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Lorna McNeill
Phone: 713-563-1103

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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