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Completed

NCT Number: NCT05324098

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STAND-T platform

Other

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

Other names: STAND-T

Survey Administration

Other

Satisfaction and follow-up surveys will be administered to participants

Text messages

Other

Participants will receive periodic text messages

Other names: Short Message Service (SMS) Text

Primary outcomes

  1. Completion rate

    Time frame: Up to 3 months

    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 outcomes

  1. Participants reported satisfaction level

    Time frame: Up to 3 months

    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.

  2. Change in the proportion of men who were Extremely Satisfied/Satisfied

    Time frame: Up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Myovant Sciences GmbH

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2022
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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