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

NCT03575832 | Active Not Recruiting

• 2 other identifiers: 2017-0556NCI-2018-01406
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Recruitment and retention

  Rates of study eligibility, recruitment, and retention will be assessed. Will maintain detailed information during the recruitment process regarding numbers of patients and their partners interested, eligible, ineligible (and reasons for ineligibility), and enrolled (and reasons for choosing not to enroll if deemed eligible). Will calculate rates of study eligibility, recruitment, and retention, along with 90% confidence intervals (CIs). Participant feedback will be summarized using means and standard deviations (SDs), along with graphical display (e.g., box plots). Will also assess reasons for withdrawal from study among those that chose to withdraw. Will examine the differences between dropout and non-dropout group at each time point by demographic factors such as age, gender, marital status, education, and income.

  Up to 8 months

• Intervention adherence

  The intervention adherence rate for each dyad is defined as the proportion of intervention sessions completed by both the patient and partner. Will also look at percentage of both patient and partner completing a minimum of 7 out of 10 coaching calls and both nutrition counseling sessions.

  Up to 8 months

Secondary Outcomes (2)

• Surveillance lifestyle

  Up to 8 months

• Elements of the intervention that were successful and/or need improvements

  Up to 8 months

Study Arms (1)

Supportive care (exercise, nutrition counseling)

EXPERIMENTAL

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.

Other: Counseling; Other: Informational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

Interventions

Counseling OTHER

Complete nutrition counseling sessions

Also known as: Counseling Intervention

Supportive care (exercise, nutrition counseling)

Informational Intervention OTHER

Receive an exercise plan and printed materials

Supportive care (exercise, nutrition counseling)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (exercise, nutrition counseling)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (exercise, nutrition counseling)

Telephone-Based Intervention BEHAVIORAL

Receive telephone coaching calls

Supportive care (exercise, nutrition counseling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (2)

Harris Health System (LBJ)

Houston, Texas, 77026, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Counseling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lorna McNeill

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 3, 2018
• Study Start: January 25, 2018
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 19, 2026

Record last verified: 2025-08

Locations

US (2)