Prostate CancerNCT05324098
Leveraging Technology to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy
A study testing STAND-T platform, Survey Administration and Text Messages in people with Prostate Cancer, run by University of California, San Francisco at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- STAND-T platform, Survey Administration and Text Messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2022to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
University of California, San Francisco
San Francisco, California, 94142
About this study
Official title: Leveraging Technology (STAND-T) 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- To measure preliminary estimates of acceptability and usage of a digital platform, STAND-T.
EXPLORATORY OBJECTIVE:
- 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
- Prostate Cancer
- Being tested
- STAND-T platform, Survey Administration, Text Messages
- Keywords
- Health Technologies
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAND-T platformOther
Also called STAND-T
Internet-based intervention comprised of evidence-based, patient materials and resources
Survey AdministrationOther
Satisfaction and follow-up surveys will be administered to participants
Text MessagesOther
Also called Short Message Service (SMS) Text
Participants will receive periodic text messages
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: STAND-T platform; Other: Survey Administration; Other: Text Messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Secondary outcomes (2)
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.
Measured: Up to 3 months
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start8 Mar 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Myovant Sciences GmbH
- Responsible party
- Sponsor
- Investigators
- Stacey Kenfield, DSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324098
- Sponsor's protocol ID
- 215514
- Other IDs
- NCI-2022-02225
- Status last verified
- Mar 2024
- First submitted
- 4 Apr 2022
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37261885
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Technology (STAND-T) to Achieve Equity for Men With Prostate Cancer on Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT05324098
- Acronym / sponsor ID
- 215514
- Conditions
- Prostate Cancer
- Keywords
- Health Technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Myovant Sciences GmbH
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- To measure preliminary estimates of acceptability and usage of a digital platform, STAND-T.
EXPLORATORY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (STAND-T, text messages) | Experimental | Other: STAND-T platform, Other: Survey Administration, Other: Text MessagesPatients review educational material and resources via online STAND-T platform. Patients also receive interactive text messages for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAND-T platformAlso: STAND-TInternet-based intervention comprised of evidence-based, patient materials and resources | Other | Health services research (STAND-T, text messages) |
| Survey AdministrationSatisfaction and follow-up surveys will be administered to participants | Other | Health services research (STAND-T, text messages) |
| Text MessagesAlso: Short Message Service (SMS) TextParticipants will receive periodic text messages | Other | Health services research (STAND-T, text messages) |
Primary outcome
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.
2 secondary outcomes
Participants reported satisfaction level
Time frame: Up to 3 months
Change in the proportion of men who were Extremely Satisfied/Satisfied
Time frame: Up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Derived from this study: PubMed 37261885Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey Kenfield, DSc principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAND-T platform, Survey Administration and Text Messages in people with Prostate Cancer, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rate (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.