An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: PATHWAYS, Enhanced usual care.
- Кому может быть актуально
- Состояния в реестре: Rectal Cancer, Self Efficacy. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
PATHWAYS: An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer
Обзор
The aim of this study is to evaluate the feasibility and acceptability of conducting a randomized trial of a brief psychoeducational intervention versus enhanced usual care for patients with locally advanced rectal cancer who are initiating neoadjuvant multimodality treatment.
Подробное описание
This is a randomized controlled trial that is split into two phases. Study Phase I tested the feasibility and acceptability of a study evaluating a psychoeducational intervention relative to a control condition for improving self-efficacy in patients with locally advanced rectal cancer initiating multimodality treatment. This phase enrolled 20 participants.
Study Part 2 was initially planned as an adequately powered RCT to evaluate intervention efficacy for enhancing patient self-efficacy for managing treatment-related challenges and maintaining quality of life. Due to the substantial refinements that were made to the PATHWAYS intervention and study procedures after Study Part 1, we have elected to change Study Part 2 to a second pilot randomized controlled trial to evaluate the feasibility and acceptability of the refined PATHWAYS study among a larger group of patients (n=60).
Participants in the intervention arm will be invited to receive the PATHWAYS intervention, including 4 coaching sessions with a study clinician focused on information and support related to multimodality treatment for LARC. Participants in the control arm will receive an information resource guide that is tailored for patients with LARC.
It is expected that about 80 people will take part in this research study.
Вмешательства
- Поведенческое PATHWAYS
The PATHWAYS intervention is a psychoeducational intervention comprised of four behavioral coaching sessions and a patient education guidebook. - Другое Enhanced usual care
The enhanced usual care condition consists of an information resource guide.
Первичные конечные точки
- Proportion of participants retained in the intervention (feasibility) [Срок оценки: 4 weeks]
Вторичные конечные точки (2)
- Proportion of patients enrolled on the study (feasibility) [Срок оценки: 12 weeks]
- Proportion of participants reporting acceptability of the intervention (acceptability) [Срок оценки: 12 weeks]
Критерии участия
Критерии включения
- Age≥18 years
- Within 8 weeks after documented decision to pursue multi-modality therapy for newly diagnosed LARC (i.e., stage II or III disease)
- Able to complete study procedures English or with the assistance of an interpreter
Критерии исключения
- Comorbid health condition that would interfere with study participation, as identified by cancer care team
- Has undergone treatment for a prior colorectal cancer
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
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 2 центра
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Идентификаторы
NCT: NCT05914766 · 23-115