Clinical trial NCT05324098: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Health Technologies
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Myovant Sciences GmbH
First posted: 2022-04-12
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Completion rate
timeFrame: Up to 3 months
Secondary outcomes:
measure: Participants reported satisfaction level
timeFrame: Up to 3 months
measure: Change in the proportion of men who were Extremely Satisfied/Satisfied
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Zuckerberg San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stacey Kenfield, DSc
role: PRINCIPAL_INVESTIGATOR
References: