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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05324098
Recruitment Status : Recruiting
First Posted : April 12, 2022
Last Update Posted : April 12, 2022
Sponsor:
Collaborator:
Myovant Sciences GmbH
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: STAND-T platform Other: Survey Administration Other: Text Messages Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 8, 2022
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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 Name: Short Message Service (SMS) Text




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05324098


Contacts
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Contact: Christine Wang 877-827-3222 Christine.Wang@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact    877-827-3222    cancertrials@ucsf.edu   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94142
Contact: Christine Wang    877-827-3222      
Contact       cancertrials@ucsf.edu   
Principal Investigator: Hala Borno, MD         
Sub-Investigator: Stacey Kenfield, ScD         
Sponsors and Collaborators
University of California, San Francisco
Myovant Sciences GmbH
Investigators
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Principal Investigator: Hala Borno, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05324098    
Other Study ID Numbers: 215514
NCI-2022-02225 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: April 12, 2022    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases