Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Starting the Conversation (STC), Time and Attention.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
Overview
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.
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.
Interventions
- 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. - 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.
Primary outcome measures
- Eligibility rate [Time frame: Baseline]
- Enrollment rate [Time frame: Baseline]
- Retention rate [Time frame: Up to Month 2 Follow-Up]
- Assessment process [Time frame: Up to Month 2 Follow-Up]
- Feasibility of Intervention Measure (FIM) [Time frame: Post-Appointment (Day 1)]
- Acceptability of Intervention Measure (AIM) [Time frame: Post-Appointment (Day 1)]
- Intervention Appropriateness Measure (IAM) [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)]
Secondary outcome measures (1)
- PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0) [Time frame: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07655557 · 26-00587 · K08CA293275