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

June 6, 2024 updated by: University of California, San Francisco

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

Completed

Conditions

Intervention / Treatment

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 (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General Hospital
      • San Francisco, California, United States, 94142
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
Up to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Myovant Sciences GmbH

Investigators

  • Principal Investigator: Stacey Kenfield, DSc, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

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 (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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