Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07655557

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

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

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Starting the Conversation (STC)

Behavioral

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.

Time and Attention

Behavioral

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.

Primary outcomes

  1. Eligibility rate

    Time frame: Baseline

    Proportion of screened individuals who are eligible

  2. Enrollment rate

    Time frame: Baseline

    Proportion of eligible individuals who enroll

  3. Retention rate

    Time frame: Up to Month 2 Follow-Up

    Proportion of enrolled participants who are not lost to follow-up

  4. Assessment process

    Time frame: Up to Month 2 Follow-Up

    Proportion of participants who completed intervention and assessments

  5. Feasibility of Intervention Measure (FIM)

    Time frame: Post-Appointment (Day 1)

    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.

  6. Acceptability of Intervention Measure (AIM)

    Time frame: Post-Appointment (Day 1)

    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.

  7. Intervention Appropriateness Measure (IAM)

    Time frame: Post-Appointment (Day 1)

    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.

  8. Number of patients who raised a sexual health topic during clinic visit

    Time frame: Post-Appointment (Day 1)

  9. Number of patients who discussed sexual health concerns during clinic visit

    Time frame: Post-Appointment (Day 1)

  10. Number of patients who asked a sexual health question during clinic visit

    Time frame: Post-Appointment (Day 1)

  11. Self Efficacy - Talking about Sexual Health

    Time frame: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up

    Self-efficacy for talking about sexual health with a healthcare provider, scored from 0-10. Higher scores indicate greater self-efficacy.

  12. Self Efficacy - Asking about Sexual Health

    Time frame: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up

    Self-efficacy for asking a healthcare provider about sexual health, scored from 0-10. Higher scores indicate greater self-efficacy.

Secondary outcomes

  1. PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)

    Time frame: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Natasha Gupta, MD

CONTACT

[email protected]

646-501-2599

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jul 1, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.