Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners

NCT ID: NCT03575832

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-25
• Study Completion Date: 2025-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Supportive care (exercise, nutrition counseling)

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.

Group Type: EXPERIMENTAL

Counseling

Intervention Type: OTHER

Complete nutrition counseling sessions

Informational Intervention

Intervention Type: OTHER

Receive an exercise plan and printed materials

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type: BEHAVIORAL

Receive telephone coaching calls

Interventions

Counseling

Complete nutrition counseling sessions

Intervention Type: OTHER

Informational Intervention

Receive an exercise plan and printed materials

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Telephone-Based Intervention

Receive telephone coaching calls

Intervention Type: BEHAVIORAL

Other Intervention Names

Counseling Intervention; Quality of Life Assessment

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorna McNeill

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Harris Health System (LBJ)

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2018-01406

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0556

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0556

Identifier Type: -

Identifier Source: org_study_id