Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
29. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Natasha Gupta, MD
- Telefonnummer: 646-501-2599
- E-post: Natasha.gupta@nyulangone.org
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10016
- NYU Langone Health
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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.
|
|
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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Eligibility rate
Tidsramme: Baseline
|
Proportion of screened individuals who are eligible
|
Baseline
|
|
Enrollment rate
Tidsramme: Baseline
|
Proportion of eligible individuals who enroll
|
Baseline
|
|
Retention rate
Tidsramme: Up to Month 2 Follow-Up
|
Proportion of enrolled participants who are not lost to follow-up
|
Up to Month 2 Follow-Up
|
|
Assessment process
Tidsramme: Up to Month 2 Follow-Up
|
Proportion of participants who completed intervention and assessments
|
Up to Month 2 Follow-Up
|
|
Feasibility of Intervention Measure (FIM)
Tidsramme: 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.
|
Post-Appointment (Day 1)
|
|
Acceptability of Intervention Measure (AIM)
Tidsramme: 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.
|
Post-Appointment (Day 1)
|
|
Intervention Appropriateness Measure (IAM)
Tidsramme: 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.
|
Post-Appointment (Day 1)
|
|
Number of patients who raised a sexual health topic during clinic visit
Tidsramme: Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
|
Number of patients who discussed sexual health concerns during clinic visit
Tidsramme: Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
|
Number of patients who asked a sexual health question during clinic visit
Tidsramme: Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
|
Self Efficacy - Talking about Sexual Health
Tidsramme: 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.
|
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
|
Self Efficacy - Asking about Sexual Health
Tidsramme: 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.
|
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
Tidsramme: 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.
|
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Natasha Gupta, MD, NYU Langone Health
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
31. oktober 2028
Studiet fullført (Antatt)
31. oktober 2028
Datoer for studieregistrering
Først innsendt
11. juni 2026
Først innsendt som oppfylte QC-kriteriene
11. juni 2026
Først lagt ut (Faktiske)
18. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-00587
- K08CA293275 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
Datasets that can be shared will be deposited in open ICPSR.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .