An interventional study of Starting the Conversation (STC) and Time and Attention in Prostate Cancer, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
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
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 rate
Proportion of screened individuals who are eligible
Time frame: Baseline
Enrollment rate
Proportion of eligible individuals who enroll
Time frame: Baseline
Retention rate
Proportion of enrolled participants who are not lost to follow-up
Time frame: Up to Month 2 Follow-Up
Assessment process
Proportion of participants who completed intervention and assessments
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-Appointment (Day 1)
Number of patients who raised a sexual health topic during clinic visit
Time frame: Post-Appointment (Day 1)
Number of patients who discussed sexual health concerns during clinic visit
Time frame: Post-Appointment (Day 1)
Number of patients who asked a sexual health question during clinic visit
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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.
Time frame: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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