Clinical trial · Interventional

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

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

NCT03575832CI-TRIAL-00121498active not recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (9)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Stage IIA Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER	0.78
Stage IIB Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER	0.78
Stage IIC Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER	0.78
Stage IIIA Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER	0.78
Stage IIIB Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER	0.78
Stage IIIC Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER	0.78
Stage III Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER	0.78
Stage II Prostate Cancer AJCC v8	Malignant Prostate Neoplasm	CURATED_BROADER

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Counseling	Other	—	UNRESOLVED
Informational Intervention	Other	—	UNRESOLVED
Quality-of-Life Assessment	Other	—	UNRESOLVED
Questionnaire Administration	Other	—	UNRESOLVED
Telephone-Based Intervention	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Supportive care (exercise, nutrition counseling)
description
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.
interventionNames
1. Other: Counseling
2. Other: Informational Intervention
3. Other: Quality-of-Life Assessment
4. Other: Questionnaire Administration
5. Behavioral: Telephone-Based Intervention

Primary outcomes (2)

measure
Recruitment and retention
timeFrame
Up to 8 months
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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)

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jan 25, 2018
Primary completion: Dec 31, 2028
Completion: Dec 31, 2028
First posted: Jul 3, 2018
Last update posted: Aug 11, 2026
Enrollment: 64 (actual)
Lead sponsor: M.D. Anderson Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)

Data updated 22 days agoSource updated Aug 11, 2026source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United States	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.