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

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05324098
Collaborator
Myovant Sciences GmbH (Industry)
50
Enrollment
2
Locations
1
Arm
9.8
Anticipated Duration (Months)
25
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: STAND-T platform
  • Other: Survey Administration
  • Other: Text Messages
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. To measure preliminary estimates of acceptability and usage of a digital platform, STAND-T.
EXPLORATORY OBJECTIVE:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Leveraging Technology (STAND-T) to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy
Actual Study Start Date :
Mar 8, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • Received or planning to receive antiandrogen therapy (ADT) (oral or injection) with gonadotropin-releasing hormone (GnRH) antagonist or luteinizing hormone releasing hormone (LHRH) agonist with first dose no more than 6 months prior to study consent

    • 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

    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

    • = 150 minutes of moderate to vigorous aerobic exercise based on Godin survey

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zuckerberg San Francisco General Hospital San Francisco California United States 94110
    2 University of California, San Francisco San Francisco California United States 94142

    Sponsors and Collaborators

    • University of California, San Francisco
    • Myovant Sciences GmbH

    Investigators

    • Principal Investigator: Hala Borno, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05324098
    Other Study ID Numbers:
    • 215514
    • NCI-2022-02225
    First Posted:
    Apr 12, 2022
    Last Update Posted:
    Apr 12, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of California, San Francisco
    Health Technologies
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Apr 12, 2022