Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
29 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Natasha Gupta, MD
- Numéro de téléphone: 646-501-2599
- E-mail: Natasha.gupta@nyulangone.org
Lieux d'étude
-
-
New York
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New York, New York, États-Unis, 10016
- NYU Langone Health
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Eligibility rate
Délai: Baseline
|
Proportion of screened individuals who are eligible
|
Baseline
|
|
Enrollment rate
Délai: Baseline
|
Proportion of eligible individuals who enroll
|
Baseline
|
|
Retention rate
Délai: 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
Délai: 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)
Délai: 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.
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Post-Appointment (Day 1)
|
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Acceptability of Intervention Measure (AIM)
Délai: 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)
|
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Intervention Appropriateness Measure (IAM)
Délai: 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)
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Number of patients who raised a sexual health topic during clinic visit
Délai: 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
Délai: 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
Délai: Post-Appointment (Day 1)
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Post-Appointment (Day 1)
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Self Efficacy - Talking about Sexual Health
Délai: 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
Délai: 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.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
Délai: 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.
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Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Natasha Gupta, MD, NYU Langone Health
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 octobre 2028
Achèvement de l'étude (Estimé)
31 octobre 2028
Dates d'inscription aux études
Première soumission
11 juin 2026
Première soumission répondant aux critères de contrôle qualité
11 juin 2026
Première publication (Réel)
18 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 26-00587
- K08CA293275 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Critères d'accès au partage IPD
Datasets that can be shared will be deposited in open ICPSR.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .