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Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans

Primary Purpose

Cancer Survivor, Partner, Spouse

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Intervention

Informational Intervention

Interview

Nutritional Assessment

Questionnaire Administration

Telephone-Based Intervention

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Group I (exercise plan, coaching calls, nutrition counseling)

Group II (physical activity/healthy eating information)

Provider Interviews (interviews)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men

We will calculate rates of recruitment and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs)

Secondary Outcome Measures

Full Information

NCT ID

NCT04215029

First Posted

November 26, 2019

Last Updated

August 28, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

Brander Beacons Cancer Research, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04215029

Brief Title

Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans

Official Title

Reducing Prostate Cancer Disparities Among African Americans

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 27, 2019 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Brander Beacons Cancer Research, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group I (exercise plan, coaching calls, nutrition counseling)

Arm Type

Experimental

Arm Description

Arm Title

Group II (physical activity/healthy eating information)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Provider Interviews (interviews)

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention

Intervention Description

Receive exercise plan

Intervention Type

Other

Intervention Name(s)

Informational Intervention

Intervention Description

Receive printed exercise materials

Intervention Type

Other

Intervention Name(s)

Informational Intervention

Intervention Description

Receive physical activity and healthy eating information/materials

Intervention Type

Other

Intervention Name(s)

Interview

Intervention Description

Participate in interview

Intervention Type

Other

Intervention Name(s)

Nutritional Assessment

Other Intervention Name(s)

Dietary Assessment, dietary counseling, nutritional counseling

Intervention Description

Complete nutrition counseling sessions

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Behavioral

Intervention Name(s)

Telephone-Based Intervention

Intervention Description

Receive coaching calls

Primary Outcome Measure Information:

Title

Implementing a lifestyle intervention and active surveillance on couple-based behavioral intervention developed for African American (AA) or Hispanic men

Description

We will calculate rates of recruitment and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs)

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dalnim Cho

Phone

713-745-8476

dcho1@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dalnim Cho

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dalnim Cho

Phone

713-745-8476

First Name & Middle Initial & Last Name & Degree

Dalnim Cho

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

MD Anderson Cancer Center Website

Learn more about this trial

Lifestyle Intervention for the Reduction of Prostate Cancer Disparities Among African Americans

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