Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
11. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
100
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Natasha Gupta, MD
- Telefonnummer: 646-501-2599
- E-Mail: Natasha.gupta@nyulangone.org
Studienorte
-
-
New York
-
New York, New York, Vereinigte Staaten, 10016
- NYU Langone Health
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
|
Aktiver 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Eligibility rate
Zeitfenster: Baseline
|
Proportion of screened individuals who are eligible
|
Baseline
|
|
Enrollment rate
Zeitfenster: Baseline
|
Proportion of eligible individuals who enroll
|
Baseline
|
|
Retention rate
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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.
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Post-Appointment (Day 1)
|
|
Number of patients who raised a sexual health topic during clinic visit
Zeitfenster: Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
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Number of patients who discussed sexual health concerns during clinic visit
Zeitfenster: Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
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Number of patients who asked a sexual health question during clinic visit
Zeitfenster: Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
|
Self Efficacy - Talking about Sexual Health
Zeitfenster: 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.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
|
Self Efficacy - Asking about Sexual Health
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Natasha Gupta, MD, NYU Langone Health
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. August 2026
Primärer Abschluss (Geschätzt)
31. Oktober 2028
Studienabschluss (Geschätzt)
31. Oktober 2028
Studienanmeldedaten
Zuerst eingereicht
11. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Juni 2026
Zuerst gepostet (Tatsächlich)
18. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 26-00587
- K08CA293275 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD-Sharing-Zugriffskriterien
Datasets that can be shared will be deposited in open ICPSR.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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