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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Starting the Conversation (STC); Behavioral: Time and Attention

Detailed Description

The investigators will conduct a pilot RCT of STC adapted for PCa with 100 patients randomly assigned to the intervention or control arm in a 1:1 ratio. Primary feasibility outcomes are clinical trial metrics and feasibility, acceptability, and appropriateness of STC. Primary efficacy outcomes are self-efficacy for sexual health communication with providers and rates of sexual health communication with providers. Secondary efficacy outcomes are sexual health outcomes (use of therapies for sexual dysfunction, sexual activity, and sexual satisfaction). Measures of efficacy will be compared between the intervention and control groups.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natasha Gupta, MD; Phone Number: 646-501-2599; Email: Natasha.gupta@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Individual with impaired decision-making capacity.
• Participation in another part of this study (prior aim)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exposure to STC Intervention; Participants 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.	Behavioral: Starting the Conversation (STC); 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.
Active Comparator: Control Arm; The 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.	Behavioral: Time and Attention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)	Questions from the domains of 1) engagement in sexual activity and 2) use of therapeutic aids for sexual activity will be converted into dichotomous variables; proportions will be evaluated at each time point as well as over time using a Z-test for differences in proportions between groups; higher scores indicate greater sexual function and satisfaction. The domain of global satisfaction with sex life will be assessed as the change over time and compared between groups using two-sample t-tests.	Baseline, Post-Appointment (Day 1), Month 2 Follow-Up

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Natasha Gupta, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Prostate Cancer; Health Communication; Sexual Health
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physical Phenomena; Time
• Other Study ID Numbers: 26-00587; K08CA293275 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: Datasets that can be shared will be deposited in open ICPSR.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No