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Идёт набор NCT05984589

Personalized Health Self-Management Training for Colorectal Cancer Survivors

Без фазы С лечением Colorectal Cancer Healthy Lifestyle Behavior, Health Health Behavior

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: RISE Personalized Self-Management Training (PSMT), Standardized Self-Management Training (SSMT).
Кому может быть актуально
Состояния в реестре: Colorectal Cancer, Healthy Lifestyle, Behavior, Health, Health Behavior. 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

A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Gastrointestinal Cancer (GI) Patients

Обзор

This is a Phase 2 prospective, randomized, controlled, double-arm study to assess personalized self-management training (PSMT) intervention efficacy and patient experiences compared to standardized self-management training (SSMT). A total of 120 gastrointestinal (GI) cancer patients will be enrolled and randomized 1:1 to complete a 6-week self-management training program (either PSMT or SSMT) to be carried out by licensed occupational therapists with doctoral training. This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in GI cancer patients.

Вмешательства

  • Поведенческое RISE Personalized Self-Management Training (PSMT)
    Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivat
  • Поведенческое Standardized Self-Management Training (SSMT)
    Participants randomized to the control condition will receive 6 standardized sessions from one of the occupational therapy (OT) interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research particip

Первичные конечные точки

  • To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups. [Срок оценки: 12 weeks.]
Вторичные конечные точки (3)
  • The difference in general self-efficacy between the two groups after the 6-week self-management program will be measured by Patient-Reported Outcomes Measurement Systems (PROMIS) Item Bank v1.0 - General Self-Efficacy Short Form 4a. [Срок оценки: 12 weeks.]
  • To evaluate the difference in health-related quality of life between the two groups after completion of the self-management program, we will use the PROMIS Scale v1.2 - Global Health questionnaire . [Срок оценки: 12 weeks.]
  • To assess percent change across the various component scores on the WCRF/AICR (e.g. grams of fiber) to better understand what might be driving any changes in the overall WCRF/AICR composite score. [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Age ≥18 years at the time of consent.
  • History of Stage I-IV colorectal cancer (CRC) or other gastrointestinal cancer within the past 10 years prior to enrollment.
  • Ability to speak, write, and read English sufficiently to allow for program participation.
  • Identified by self-report as having willingness and interest to work on at least one lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical activity, body composition, alcohol use.
  • Scoring ≤3.5 on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Health Behavior Adherence Scale or in the low-to-moderate range in any subcategory consistent with moderate to low adherence to healthy behavior recommendations (HBRs).
  • Ambulatory and independent in activities of daily living (ADL).
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Критерии исключения

  • Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.

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
  • Cedars-Sinai Medical Center — Los Angeles
  • University of Southern California — Los Angeles

Идентификаторы

NCT: NCT05984589 · 3C-24-9 · 1K01HD110719

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗