Cooperative Extension and Cancer Survivorship
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: SUCCESS.
- Кому может быть актуально
- Состояния в реестре: Cancer Survivorship. 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
Cooperative Extension and Cancer Survivorship: Supportive Care Via Cooperative Extension Services (SUCCESS)
Обзор
The goal of this clinical trial is to learn if a cancer survivor program, delivered via Cooperative Extension, is feasible and if it can improve health outcomes in cancer survivors who are post-active treatment. Aim 1: Evaluate the feasibility and acceptability of SUCCESS. Hypothesis 1: SUCCESS will be feasible and acceptable as evidenced by delivery of the intervention among Educators (implementation), including in agreement with the curriculum in Phase 1 (fidelity) with \>85% attendance (demand) among participants with \>80% rating the intervention as acceptable or highly acceptable on 5-point Likert-type scale (acceptability). Aim 2: Determine the preliminary efficacy of SUCCESS for improving HRQOL (primary outcome) and other psychosocial and health-related endpoints (e.g., financial toxicity) (secondary outcomes). Hypothesis 2: Compared to matched controls, adults LWBC who complete SUCCESS will have significant improvements in HRQOL per the PROMIS Global Health v1.2 at follow-up (i.e., after 6 weeks). Aim 3: Examine changes in conserved transcriptional response to adversity (CTRA) gene expression in a subset of interventions participants at follow-up. Hypothesis 3: Adults LWBC who complete SUCCESS will experience significant CTRA down-regulation. This is a single arm trial and there is no comparison group. Participants will be asked to do survey- and Zoom-based data collection before and after completing the 6-week program.
Вмешательства
- Поведенческое SUCCESS
6 group-based sessions with 25 minutes of didactic content, 25 minutes of facilitated support group, and 10 minutes of group physical activity
Первичные конечные точки
- Delivery of sessions [Срок оценки: Once per week for six weeks]
- Fidelity to SUCCESS protocol [Срок оценки: Once per week for six weeks]
- Participant attendance [Срок оценки: Once per week for six weeks]
- Acceptability of SUCCESS [Срок оценки: Measured after SUCCESS (week 7-8 of the clinical trial)]
Вторичные конечные точки (12)
- Diet quality [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Physical function [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Depressive symptoms [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Anxiety symptoms [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Loneliness [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Social isolation [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Financial Toxicity [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Health-related quality of life [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Food insecurity [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Basic psychological needs [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Self-reported pain [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
- Conserved Transcriptional Response to Adversity (CTRA) gene expression [Срок оценки: Baseline (week 1) and post-SUCCESS (week 7-8)]
Критерии участия
Критерии включения
- Previous adult-diagnosed cancer
- Post active cancer treatment
- No current active treatment, hormonal therapy permitted
- Ability to get to group sessions
- In Oklahoma
Критерии исключения
- Current palliative or hospice care
- Surgical or medical history that precludes participation
- Positive screen on the Physical Activity Readiness Questionnaire+ (PAR-Q+) without a doctor's note approving study participation
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 1 центр
- University of Oklahoma — Tulsa
Публикации
- Pitasi O, Hildebrand D, Liebe R, Joyce J, Nagykaldi Z, Robertson MC, Braun A. Hiding in plain sight: Cooperative Extension as an underutilized approach to improving cancer survivorship outcomes in underserved populations. J Cancer Surviv. 2026 Apr;20(2):792-803. doi: 10.1007/s11764-024-01687-z. Epub 2024 Oct 10. PMID 39388009
Идентификаторы
NCT: NCT06869512 · 17371