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

Stage III Prostate Cancer AJCC v8 Clinical Trial

Official title:

Watchful Living: A Lifestyle Intervention for Black and Hispanic Prostate Cancer Patients and Their Partners

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03575832
• Other study ID #: 2017-0556
• Secondary ID: NCI-2018-0140620
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostatic Neoplasms
• 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

Intervention

Other:
• Counseling
Complete nutrition counseling sessions
• Informational Intervention
Receive an exercise plan and printed materials
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive telephone coaching calls

Locations

Country	Name	City	State
United States	Harris Health System (LBJ)	Houston	Texas
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Surveillance lifestyle	Will report means, standard deviations, and distributions of survey measures (including pre-post changes of these measures, as appropriate) for ceiling/floor effects and restrictions in range. Outcome measures will be treated as continuous variables. Linear mixed models will be used when combined data from both patients and partners are analyzed due to their correlation within couples. Two-sided statistical tests will be performed, and the significance level for each test will be set at 0.05 without adjustment for multiple testing. All results from the statistical tests will be interpreted as hypothesis generating rather than conclusive findings. Will also perform paired t-tests to compare efficacy outcomes of interest between baseline and post intervention separately for patients and partners.	Up to 8 months
Secondary	Elements of the intervention that were successful and/or need improvements	Will conduct focus groups with a subsample of patient-partner dyads. Questions will address participants' experiences; thoughts about strengths, weaknesses, and needed improvements; perceptions about outcomes and impact; and overall reactions to and satisfaction with the intervention.	Up to 8 months

External Links

•   MD Anderson Cancer Center Website