Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
29 juni 2026 bijgewerkt door: NYU Langone Health
Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Natasha Gupta, MD
- Telefoonnummer: 646-501-2599
- E-mail: Natasha.gupta@nyulangone.org
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10016
- NYU Langone Health
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Exposure to STC Intervention
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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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.
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Actieve vergelijker: Control Arm
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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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Eligibility rate
Tijdsspanne: Baseline
|
Proportion of screened individuals who are eligible
|
Baseline
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Enrollment rate
Tijdsspanne: Baseline
|
Proportion of eligible individuals who enroll
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Baseline
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Retention rate
Tijdsspanne: Up to Month 2 Follow-Up
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Proportion of enrolled participants who are not lost to follow-up
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Up to Month 2 Follow-Up
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Assessment process
Tijdsspanne: Up to Month 2 Follow-Up
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Proportion of participants who completed intervention and assessments
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Up to Month 2 Follow-Up
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Feasibility of Intervention Measure (FIM)
Tijdsspanne: Post-Appointment (Day 1)
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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.
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Post-Appointment (Day 1)
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Acceptability of Intervention Measure (AIM)
Tijdsspanne: Post-Appointment (Day 1)
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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.
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Post-Appointment (Day 1)
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Intervention Appropriateness Measure (IAM)
Tijdsspanne: Post-Appointment (Day 1)
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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.
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Post-Appointment (Day 1)
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Number of patients who raised a sexual health topic during clinic visit
Tijdsspanne: Post-Appointment (Day 1)
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Post-Appointment (Day 1)
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Number of patients who discussed sexual health concerns during clinic visit
Tijdsspanne: Post-Appointment (Day 1)
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Post-Appointment (Day 1)
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Number of patients who asked a sexual health question during clinic visit
Tijdsspanne: Post-Appointment (Day 1)
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Post-Appointment (Day 1)
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Self Efficacy - Talking about Sexual Health
Tijdsspanne: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Self-efficacy for talking about sexual health with a healthcare provider, scored from 0-10.
Higher scores indicate greater self-efficacy.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Self Efficacy - Asking about Sexual Health
Tijdsspanne: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
Tijdsspanne: Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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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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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Natasha Gupta, MD, NYU Langone Health
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 augustus 2026
Primaire voltooiing (Geschat)
31 oktober 2028
Studie voltooiing (Geschat)
31 oktober 2028
Studieregistratiedata
Eerst ingediend
11 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
11 juni 2026
Eerst geplaatst (Werkelijk)
18 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
29 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 26-00587
- K08CA293275 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD-toegangscriteria voor delen
Datasets that can be shared will be deposited in open ICPSR.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .