SCIPI Implementation and Evaluation: A Multi-site Proof-of-Concept Pilot Trial

Официальное название

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

Обзор

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 feasible to integrate SCIPI in prostate cancer clinical care via the electronic medical record and whether SCIPI may improve patients' confidence in making treatment decisions and their overall quality of life compared with usual care. The study will include patients who are newly diagnosed with prostate cancer. Participants will be randomly assigned to use SCIPI or to receive usual care, and information will be collected over time about their experiences, decision-making, and quality of life.

Подробное описание

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 (T1), participants will be randomly assigned to either the SCIPI intervention or usual care. Data will be collected at 3 months (T2) and 6 months (T3) to evaluate decision satisfaction, quality of life, symptom burden, self-efficacy, and program usability.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Satisfaction with Decision (SWD) [Срок оценки: 3-month follow-up (T2) and 6-month follow-up (T3)]

Вторичные конечные точки (1)

• Quality of Life (FACT-G) [Срок оценки: Baseline (T1), 3-month follow-up (T2), 6-month follow-up (T3)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at San Antonio School of Nursing — San Antonio

Идентификаторы

NCT: NCT07280897 · STUDY00001556 · E06709.1a

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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