Leveraging Technology to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Other: STAND-T platform; Other: Survey Administration; Other: Text Messages

• Registration Number: NCT05324098
• Lead Sponsor: University of California, San Francisco

Brief Summary

This clinical trial studies a digital platform, the supportive therapy in androgen deprivation (STAND-T), in achieving equity for men undergoing treatment with androgen deprivation therapy for prostate cancer. STAND-T is a digital platform that provides prostate health information, evidence-based materials and resources. STAND-T may help improve health, address symptoms, and promote equity in men with prostate cancer.

Detailed Description

PRIMARY OBJECTIVE:

I. To assess study feasibility of the STAND-T program at the Helen Diller Family Comprehensive Cancer Center (HDFCCC) and Zuckerberg San Francisco General Hospital and Trauma Center (ZSFG) genitourinary (GU) medical, surgical, and radiation oncology practices.

SECONDARY OBJECTIVE:

I. To measure preliminary estimates of acceptability and usage of a digital platform, STAND-T.

EXPLORATORY OBJECTIVE:

I. To describe diet (e.g., fruit and vegetable intake), lifestyle (e.g., moderate to vigorous exercise, smoking status), clinical (symptoms e.g., fatigue), and health related quality of life (QoL) outcomes (e.g., sleep disturbance), physiologic measures (body mass index, BMI) at baseline and change in these metrics from baseline to 3 months post-intervention.

OUTLINE:

Patients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months.

After completion of study, patients are followed up at 3 months.

Study Timeline

• Study Start: 2022-03-08
• Study First Submitted: 2022-04-04
• Study First Submitted QC: 2022-04-04
• Study First Posted: 2022-04-12
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 47

Inclusion Criteria

• Age >18 years
• Ability to understand study procedures and to comply with them for the entire length of the study
• Ability of individual or legal guardian/representative to understand an informed consent document and the willingness to sign it
• Adenocarcinoma of the prostate
• Current or planned anti-androgen therapy (ADT) (oral or injection) with gonadotropin-releasing hormone (GnRH) antagonist or luteinizing hormone releasing hormone (LHRH) agonist
• Life expectancy duration of 6 months or longer from date of study consent
• Prior and concurrent radiation is allowed
• Treatment with concurrent androgen signaling inhibitors is allowed
• < 75 minutes/week of vigorous aerobic exercise based on Godin survey or < 2 days per week of vigorous activity

Exclusion Criteria

• Contraindication to any study-related procedure or assessment
• Planned surgery/chemotherapy/immunotherapy/parp inhibitor treatment during the study period
• Prior and concurrent investigational therapies
• Unable to read/speak English
• Unable to access the Internet
• Has seen an exercise counselor in the past 6 months for prostate or cardiovascular health
• Has seen a dietary counselor in the past 6 months for prostate or cardiovascular health

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Health services research (STAND-T, text messages)	STAND-T platform	Patients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months.
Health services research (STAND-T, text messages)	Text Messages	Patients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months.
Health services research (STAND-T, text messages)	Survey Administration	Patients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months.

Primary Outcome Measures

Name	Time	Method
Completion rate	Up to 3 months	The point estimation and 95% confidence interval (CI) of the percentage of participants who complete the 3-month study will be obtained overall and by race/ethnicity and geography.

Secondary Outcome Measures

Name	Time	Method
Participants reported satisfaction level	Up to 3 months	Satisfaction will be measured on a likert scale: Extremely Unsatisfied, Dissatisfied, Neither Satisfied or Dissatisfied, Satisfied, Extremely Satisfied. The point estimation and 95% CI of the percentage (95% CI) of participants who are satisfied or extremely satisfied with the program at 3 months will be obtained.
Change in the proportion of men who were Extremely Satisfied/Satisfied	Up to 3 months	Satisfaction will be measured on a likert scale: Extremely Unsatisfied, Dissatisfied, Neither Satisfied or Dissatisfied, Satisfied, Extremely Satisfied. Change in the percentage (proportion) of men who were Extremely Satisfied/Satisfied from 7 days to 3 months will be reported.

Trial Locations

Locations (2)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States