Leveraging Technology to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy
NCT ID: NCT05324098
Last Updated: 2024-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
47 participants
INTERVENTIONAL
2022-03-08
2023-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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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
* 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
* 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
18 Years
MALE
No
Sponsors
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Myovant Sciences GmbH
INDUSTRY
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Stacey Kenfield, DSc
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Zuckerberg San Francisco General Hospital
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Countries
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References
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Wang EY, Borno HT, Washington Iii SL, Friedlander T, Zhang S, Trejo E, Van Blarigan EL, Chan JM, Shariff-Marco S, Beatty AL, Kenfield SA. Engaging Men of Diverse Racial and Ethnic Groups With Advanced Prostate Cancer in the Design of an mHealth Diet and Exercise Intervention: Focus Group Study. JMIR Cancer. 2023 Jun 1;9:e45432. doi: 10.2196/45432.
Other Identifiers
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NCI-2022-02225
Identifier Type: REGISTRY
Identifier Source: secondary_id
215514
Identifier Type: -
Identifier Source: org_study_id
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