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

M.D. Anderson Cancer Center

Status

Active, not recruiting

Conditions

Stage IIIC Prostate Cancer AJCC v8

Stage I Prostate Cancer AJCC v8

Stage IIA Prostate Cancer AJCC v8

Stage IIC Prostate Cancer AJCC v8

Stage IIIB Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage IIIA Prostate Cancer AJCC v8

Stage IIB Prostate Cancer AJCC v8

Treatments

Other: Informational Intervention

Other: Counseling

Behavioral: Telephone-Based Intervention

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03575832

2017-0556 (Other Identifier)

NCI-2018-01406 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)