Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
11. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Natasha Gupta, MD
- Telefonnummer: 646-501-2599
- E-mail: Natasha.gupta@nyulangone.org
Studiesteder
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New York
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New York, New York, Forenede Stater, 10016
- NYU Langone Health
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Eligibility rate
Tidsramme: Baseline
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Proportion of screened individuals who are eligible
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Baseline
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Enrollment rate
Tidsramme: Baseline
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Proportion of eligible individuals who enroll
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Baseline
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Retention rate
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Post-Appointment (Day 1)
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Post-Appointment (Day 1)
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Self Efficacy - Talking about Sexual Health
Tidsramme: 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
Tidsramme: 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.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Natasha Gupta, MD, NYU Langone Health
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
31. oktober 2028
Studieafslutning (Anslået)
31. oktober 2028
Datoer for studieregistrering
Først indsendt
11. juni 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
18. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-00587
- K08CA293275 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD-delingsadgangskriterier
Datasets that can be shared will be deposited in open ICPSR.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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Kliniske forsøg med Starting the Conversation (STC)
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Milton S. Hershey Medical CenterUniversity of Kentucky; Hospice Foundation of AmericaAktiv, ikke rekrutterendeMeddelelse | Dødelig sygdom | Kronisk sygdom | Forudgående plejeplanlægning | ForhåndsdirektiverForenede Stater