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

Leveraging Technology (STAND-T) to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: STAND-T platform; Other: Survey Administration; Other: Text Messages

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Wang; Phone Number: 877-827-3222; Email: Christine.Wang@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • Recruiting
      • Zuckerberg San Francisco General Hospital
      • Contact: Phone Number: 877-827-3222; Email: cancertrials@ucsf.edu
    • San Francisco, California, United States, 94142
      • Recruiting
      • University of California, San Francisco
      • Contact: Christine Wang; Phone Number: 877-827-3222
      • Principal Investigator: Hala Borno, MD
      • Sub-Investigator: Stacey Kenfield, ScD
      • Contact: Email: cancertrials@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Health services research (STAND-T, text messages); Patients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months.	Other: STAND-T platform; Internet-based intervention comprised of evidence-based, patient materials and resources; Other Names: STAND-T; Other: Survey Administration; Satisfaction and follow-up surveys will be administered to participants; Other: Text Messages; Participants will receive periodic text messages; Other Names: Short Message Service (SMS) Text

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate	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.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants reported satisfaction level	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.	Up to 3 months
Change in the proportion of men who were Extremely Satisfied/Satisfied	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.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Myovant Sciences GmbH
• Investigators: Principal Investigator: Hala Borno, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Health Technologies
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 215514; NCI-2022-02225 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No