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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STAND-T platform
Survey Administration
Text Messages
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring Health Technologies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zuckerberg San Francisco General HospitalRecruiting
  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health services research (STAND-T, text messages)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 4, 2022
Last Updated
October 26, 2022
Sponsor
University of California, San Francisco
Collaborators
Myovant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05324098
Brief Title
Leveraging Technology to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy
Official Title
Leveraging Technology (STAND-T) to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Myovant Sciences GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Health Technologies

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health services research (STAND-T, text messages)
Arm Type
Experimental
Arm Description
Patients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months.
Intervention Type
Other
Intervention Name(s)
STAND-T platform
Other Intervention Name(s)
STAND-T
Intervention Description
Internet-based intervention comprised of evidence-based, patient materials and resources
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Satisfaction and follow-up surveys will be administered to participants
Intervention Type
Other
Intervention Name(s)
Text Messages
Other Intervention Name(s)
Short Message Service (SMS) Text
Intervention Description
Participants will receive periodic text messages
Primary Outcome Measure Information:
Title
Completion rate
Description
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.
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Participants reported satisfaction level
Description
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.
Time Frame
Up to 3 months
Title
Change in the proportion of men who were Extremely Satisfied/Satisfied
Description
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.
Time Frame
Up to 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Wang
Phone
877-827-3222
Email
Christine.Wang@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Borno, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zuckerberg San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
877-827-3222
Email
cancertrials@ucsf.edu
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94142
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Wang
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Hala Borno, MD
First Name & Middle Initial & Last Name & Degree
Stacey Kenfield, ScD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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