Health TrialsbyHealthPanel

Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult male with PCa at least 18 years of age

Speak English

Reside in the U.S.

Have internet/web access, and

Disqualifiers

Individual with impaired decision-making capacity.

Participation in another part of this study (prior aim)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Exposure to STC InterventionExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Eligibility rate

Proportion of screened individuals who are eligible

Time frame
Baseline
2

Enrollment rate

Proportion of eligible individuals who enroll

Time frame
Baseline
3

Retention rate

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

Time frame
Up to Month 2 Follow-Up
4

Assessment process

Proportion of participants who completed intervention and assessments

Time frame
Up to Month 2 Follow-Up

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: