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L'essai clinique NCT07280897 (SCIPI) pour Cancer de la prostate est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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SCIPI Implementation and Evaluation: A Multi-site Proof-of-Concept Pilot Trial 200
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L'essai clinique NCT07280897 (SCIPI) est une étude interventionnel pour Cancer de la prostate. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 1 octobre 2026, avec un objectif de 200 participants. Dirigée par The University of Texas Health Science Center at San Antonio, l'étude devrait être terminée d'ici le 29 septembre 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 19 décembre 2025.
Résumé succinct
This study will test a web-based supportive care program called the Support, Communication, and Information Program for Prostate Cancer - Interactive (SCIPI). SCIPI provides men with localized prostate cancer and their families with easy-to-understand information, tools to prepare for discussions with their doctors, and opportunities for social support. The purpose of this pilot study is to determine whether it is fe...Afficher plus
Description détaillée
This proof-of-concept pilot randomized clinical trial aims to test the feasibility and preliminary efficacy of SCIPI, a web-based supportive care intervention for patients with localized prostate cancer. The study will enroll 200 newly diagnosed patients across four NCI-designated cancer centers, with the option for family members to participate. After providing informed consent and completing the baseline assessment...Afficher plus
Titre officiel
Implementation and Evaluation of SCIPI: A Multi-Site Pilot Randomized Controlled Trial to Improve Decision-Making and Quality of Life Among Patients With Localized Prostate Cancer
Pathologies
Cancer de la prostateAutres identifiants de l'étude
- SCIPI
- STUDY00001556
- E06709.1a (Autre financement) (Department of Defense (DOD))
Numéro NCT
Date de début (réel)
2026-10-01
Dernière mise à jour publiée
2025-12-19
Date de fin (estimée)
2029-09-29
Inscription (estimée)
200
Type d'étude
Interventionnel
PHASE
N/A
Statut
Pas encore en recrutement
Objectif principal
Soins de soutien
Méthode d'allocation
Randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalSCIPI Participants will receive SCIPI, a web-based supportive care program delivered through the Epic MyChart system, in addition to usual care. | SCIPI SCIPI (Support, Communication, and Information Program for Prostate Cancer - Interactive) is a web-based supportive care program delivered through the Epic MyChart system. The program provides tailored educational materials, skills training, and interactive tools to support informed treatment decision-making for patients with localized prostate cancer. |
Aucune interventionUsual Care Participants will receive usual care provided at their study site. | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Satisfaction with Decision (SWD) | SWD will be assessed using the 6-item Satisfaction with Decision (SWD) scale, which measures the extent to which participants feel informed, confident, and satisfied with their prostate cancer treatment decision. Scores range from 6 to 30, with higher scores indicating greater satisfaction. | 3-month follow-up (T2) and 6-month follow-up (T3) |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Quality of Life (FACT-G) | Quality of life will be measured using Functional Assessment of Cancer Therapy - General (FACT-G). A 27-item validated questionnaire assessing physical, social/family, emotional, and functional well-being. Higher scores indicate better quality of life. | Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3) |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
Patients with localized prostate cancer:
- Age ≥ 18 years.
- Biopsy-confirmed diagnosis of localized prostate cancer (Gleason score ≤8, PSA < 30 ng/mL).
- Eligible for curative-intent treatment (e.g., surgery, radiation, or active surveillance).
- Able to read and understand English or Spanish.
- Access to the internet and the Epic MyChart patient portal at a participating study site (UTHSA, UNC, UCSD, or KUMC).
- Willing and able to provide informed consent.
Patients:
- History of metastatic or recurrent prostate cancer.
- Diagnosis of another active malignancy (excluding non-melanoma skin cancer).
- Severe cognitive impairment or psychiatric illness that would interfere with participation.
- Inability to access the internet or the MyChart portal.
- Prior participation in other related digital health trials.
The University of Texas Health Science Center at San AntonioPartie responsable de l'étude
Lixin Song, Investigateur principal, Tenured Full Professor, The University of Texas Health Science Center at San Antonio
Contact central de l'étude
Contact: Lixin Song, PhD, 210-450-8561, [email protected]
Contact: Cheongin Im, PhD, 210-567-5102, [email protected]
1 Centres de l'étude dans 1 pays
Texas
The University of Texas Health Science Center at San Antonio School of Nursing, San Antonio, Texas, 78229, United States
Cheongin Im, Postdoctoral Research Fellow, PhD, MSN, Contact, 210-567-5120, [email protected]
Lixin Song, Vice Dean for Research and Scholarship Professor, PhD, Contact, 210-450-8917, [email protected]