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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05324098
• Other study ID #: 215514
• Secondary ID: NCI-2022-02225
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• STAND-T platform
Internet-based intervention comprised of evidence-based, patient materials and resources
• Survey Administration
Satisfaction and follow-up surveys will be administered to participants
• Text Messages
Participants will receive periodic text messages

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Myovant Sciences GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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