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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA293275 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure to STC Intervention | Experimental | 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. |
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| Control Arm | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility rate | Proportion of screened individuals who are eligible | Baseline |
| Enrollment rate | Proportion of eligible individuals who enroll | Baseline |
| Retention rate | Proportion of enrolled participants who are not lost to follow-up | Up to Month 2 Follow-Up |
| Assessment process | Proportion of participants who completed intervention and assessments | 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. | 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. | Post-Appointment (Day 1) |
| Intervention Appropriateness Measure (IAM) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasha Gupta, MD | Contact | 646-501-2599 | Natasha.gupta@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Natasha Gupta, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Datasets that can be shared will be deposited in open ICPSR.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013995 | Time |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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|
| 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. |
|
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.
| Post-Appointment (Day 1) |
| 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) |
| Number of patients who asked a sexual health question during clinic visit | 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. | 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. | Baseline, Post-Appointment (Day 1), Month 2 Follow-Up |
| Baseline, Post-Appointment (Day 1), Month 2 Follow-Up |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |