Clinical trial NCT03575832: Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners
Official title: Watchful Living: A Lifestyle Intervention for Black and Hispanic Prostate Cancer Patients and Their Partners
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-07-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Self-identify as black or African American or Hispanic (patient)
* Be greater than 18 years of age (patient and spouse or intimate partner)
* 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)

Primary outcomes:
measure: Recruitment and retention
timeFrame: Up to 8 months
measure: Intervention adherence
timeFrame: Up to 8 months
Secondary outcomes:
measure: Surveillance lifestyle
timeFrame: Up to 8 months
measure: Elements of the intervention that were successful and/or need improvements
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Harris Health System (LBJ)
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill
role: PRINCIPAL_INVESTIGATOR
References: