Prostate Cancer
Conditions
Keywords
Prostate Cancer, Sexual Health, Health Communication
Brief summary
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
BEHAVIORALStarting 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.
BEHAVIORALTime 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.
Sponsors
NYU Langone Health
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who asked a sexual health question during clinic visit | Post-Appointment (Day 1) | — |
| Self Efficacy - Asking about Sexual Health | 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. |
| Self Efficacy - Talking about Sexual Health | 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. |
| Eligibility rate | Baseline | Proportion of screened individuals who are eligible |
| Enrollment rate | Baseline | Proportion of eligible individuals who enroll |
| Retention rate | Up to Month 2 Follow-Up | Proportion of enrolled participants who are not lost to follow-up |
| Assessment process | Up to Month 2 Follow-Up | Proportion of participants who completed intervention and assessments |
| Feasibility of Intervention Measure (FIM) | 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. |
| Acceptability of Intervention Measure (AIM) | 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. |
| Intervention Appropriateness Measure (IAM) | 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. |
| 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) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0) | 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. |
Countries
United States
Contacts
CONTACTNatasha Gupta, MD
PRINCIPAL_INVESTIGATORNatasha Gupta, MD
NYU Langone Health
Outcome results
None listed