NCT05324098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2022

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

June 10, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

April 4, 2022

Last Update Submit

June 6, 2024

Conditions

Prostate Cancer

Keywords

Health Technologies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Participants reported satisfaction level

    Up to 3 months

  • Change in the proportion of men who were Extremely Satisfied/Satisfied

    Up to 3 months

Study Arms (1)

Health services research (STAND-T, text messages)

EXPERIMENTAL

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

Other: STAND-T platformOther: Survey AdministrationOther: Text Messages

Interventions

STAND-T platformOTHER

Internet-based intervention comprised of evidence-based, patient materials and resources

Also known as: STAND-T
Health services research (STAND-T, text messages)
Survey AdministrationOTHER

Satisfaction and follow-up surveys will be administered to participants

Health services research (STAND-T, text messages)
Text MessagesOTHER

Participants will receive periodic text messages

Also known as: Short Message Service (SMS) Text
Health services research (STAND-T, text messages)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

University of California, San Francisco

San Francisco, California, 94142, United States

Location

Related Publications (1)

  • 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.

    PMID: 37261885DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Alkyl and Aryl TransferasesTransferasesEnzymesEnzymes and Coenzymes

Study Officials

  • Stacey Kenfield, DSc

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

March 8, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

June 10, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)