Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
2 other identifiers
interventional
100
1 country
1
Brief Summary
This is a pilot randomized controlled trial of a sexual health communication skills training multimedia intervention (Starting the Conversation \[STC\] adapted for patients with prostate cancer \[PCa\]) to improve patients' ability to communicate with providers about their sexual health concerns during PCa care compared to a time and attention control arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Aug 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2026
CompletedFirst Posted
Study publicly available on registry
June 18, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2028
July 1, 2026
June 1, 2026
2.3 years
June 11, 2026
June 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Eligibility rate
Proportion of screened individuals who are eligible
Baseline
Enrollment rate
Proportion of eligible individuals who enroll
Baseline
Retention rate
Proportion of enrolled participants who are not lost to follow-up
Up to Month 2 Follow-Up
Assessment process
Proportion of participants who completed intervention and assessments
Up to Month 2 Follow-Up
Feasibility of Intervention Measure (FIM)
FIM is a validated 4-item scale designed to evaluate whether a specific intervention or practice can be successfully implemented and carried out within a given setting. Each item is rated on a scale from 1-5; the total score is the average of the responses and ranges from 1-5; higher scores indicate greater feasibility.
Post-Appointment (Day 1)
Acceptability of Intervention Measure (AIM)
AIM is a validated 4-item scale used in implementation research to assess stakeholders' perception that a new program, treatment, or practice is agreeable and satisfactory. Each item is rated on a scale from 1-5; the total score is the average of the responses and ranges from 1-5; a higher overall average indicates a greater level of acceptability for the intervention.
Post-Appointment (Day 1)
Intervention Appropriateness Measure (IAM)
The Intervention Appropriateness Measure (IAM) is a validated, 4-item tool used in implementation science to assess the perceived fit, relevance, and suitability of an intervention. Each item is rated on scale from 1-5; the total score is the average of responses and ranges from 1-5; higher scores indicate greater appropriateness.
Post-Appointment (Day 1)
Number of patients who raised a sexual health topic during clinic visit
Post-Appointment (Day 1)
Number of patients who discussed sexual health concerns during clinic visit
Post-Appointment (Day 1)
Number of patients who asked a sexual health question during clinic visit
Post-Appointment (Day 1)
Self Efficacy - Talking about Sexual Health
Self-efficacy for talking about sexual health with a healthcare provider, scored from 0-10. Higher scores indicate greater self-efficacy.
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
Self Efficacy - Asking about Sexual Health
Self-efficacy for asking a healthcare provider about sexual health, scored from 0-10. Higher scores indicate greater self-efficacy.
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
Secondary Outcomes (1)
PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
Study Arms (2)
Exposure to STC Intervention
EXPERIMENTALParticipants will receive a multimedia intervention focused on teaching communication skills to help patients with prostate cancer discuss their sexual health concerns with their healthcare providers.
Control Arm
ACTIVE COMPARATORThe control arm will be exposed to a 2-page supportive care resource guide, as well as a video slideshow and pamphlet on diet, sleep, and exercise for patients with prostate cancer.
Interventions
20-minute slideshow, 5-page workbook, 2-page supportive care resource guide focused on sexual health and teaching communication skills to help patients with prostate cancer discuss their sexual health concerns with their healthcare providers.
2-page supportive care resource guide, as well as a 20-minute video slideshow and 5-page pamphlet on diet, sleep, and exercise for patients with prostate cancer.
Eligibility Criteria
You may qualify if:
- Adult male with PCa at least 18 years of age
- Speak English
- Reside in the U.S.
- Have internet/web access, and
- Report current bother due to sexual dysfunction
- Capacity and willingness to provide consent
- Have an appointment with a PCa provider at NYU Langone Health during the study accrual period
You may not qualify if:
- Individual with impaired decision-making capacity.
- Participation in another part of this study (prior aim)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natasha Gupta, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2026
First Posted
June 18, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
October 31, 2028
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- Datasets that can be shared will be deposited in open ICPSR.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. Datasets that can be shared will be deposited in open ICPSR. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.