Clinical trial NCT04215029: Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans
Official title: Reducing Prostate Cancer Disparities Among African Americans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Survivor
Partner
Spouse
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: Brander Beacons Cancer Research
name: National Cancer Institute (NCI)
First posted: 2020-01-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial studies how well a lifestyle intervention works in reducing prostate cancer disparities among African American prostate cancer patients and their spouses or romantic partners. A lifestyle intervention may help researchers learn if social support can help African American prostate cancer patients and their partners improve their quality of life, support from their partner, physical activity, diet, and inflammation.

Detailed description: PRIMARY OBJECTIVE:

I. To expand an existing couple-based behavioral intervention developed for African American (AA) or Hispanic men on active surveillance (Watchful Living; protocol #: 2017-0556) to AA prostate cancer (PCa) survivors who underwent active treatments to examine its feasibility of recruiting AA PCa survivor-partner dyads (N = 40 dyads) and implementing a lifestyle intervention.

SECONDARY OBJECTIVES:

I. Evaluate a preliminary efficacy of the intervention in improving quality of life, physical activity, nutrient intake, and inflammation.

II. Explore psychosocial mediators and moderators of the intervention. III. Conduct a process evaluation. IV. Assess healthcare-provider level factors (with N=15 providers) that influence both survivors' and partners' healthy lifestyle behaviors.

OUTLINE: Patients and their partners are randomized to 1 of 2 groups.

GROUP I: Patients and their partners receive an exercise plan and printed materials that includes instructions for walking or other moderate-intensity activities. Patients and their partners also receive coaching calls discussing physical activity and diet related questions, each lasting 45-60 minutes and occurring every 2 weeks for 6 months. In addition, patients and their partners complete 2 nutrition counseling sessions over 1 hour each at baseline and before month 3 with an MD Anderson registered dietitian.

GROUP II: Patients and their partners receive information/materials regarding physical activity and healthy eating.

PROVIDER INTERVIEWS: Healthcare providers participate in an interview regarding their opinions on family-focused care and its ability to improve health behaviors.

Eligibility criteria: Inclusion Criteria:

* To be eligible, prostate cancer survivors must self-identify as black or African American
* Prostate cancer survivors must have 0-III stage prostate cancer
* Prostate cancer survivors must have completed therapy (e.g., surgery, chemotherapy \[chemo\] and/or radiation)
* Prostate cancer survivors must enroll with a spouse or a romantic partner
* Prostate cancer survivors must not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week)
* Prostate cancer survivors must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
* Prostate cancer survivors must not participate in another physical activity, diet, or lifestyle program
* Prostate cancer survivors must have a valid home address and telephone number
* Prostate cancer survivors must be able to access internet over a smartphone or a computer at home or other location (e.g., work, church, library, community center, etc.)
* To be eligible, spouses or romantic partners must be \>=18 years of age
* Spouses or romantic partners must enroll with a spouse or a romantic partner with prostate cancer
* Spouses or romantic partners must live together with the survivors
* Spouses or romantic partners must not have major health problems (e.g., cancer, dementia, stroke, and heart and lung diseases)
* Spouses or romantic partners must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
* To be eligible, healthcare providers must be currently providing care with individuals diagnosed with prostate cancer
* Any professionals such as surgical and medical oncologists, fellows, nurse practitioners, physical assistants, and primary care physicians will be eligible

Exclusion Criteria:

* Prostate cancer survivors will be excluded if they are not married or partnered
* Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site
* Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
* Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period
* Prostate cancer survivors will be excluded if they are on active surveillance
* Prostate cancer survivors will be excluded if they enrolled in a protocol #: 2017-0556
* Prostate cancer survivors will be excluded if they are not able to understand and speak English
* Spouses or romantic partners who are not able to understand and speak English will be excluded
* Also, spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded
* There are no exclusion criteria for healthcare providers

Primary outcomes:
measure: Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Dalnim Cho
role: PRINCIPAL_INVESTIGATOR
References: