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Идёт набор NCT06185777

Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients

Без фазы С лечением Cancer Exercise Implementation

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: Exercise oncology counseling and referal.
Кому может быть актуально
Состояния в реестре: Cancer, Exercise, Implementation. 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

MOVE-ONKO is developing and implementing a guideline-based, multi-professional care pathway for the promotion and therapy of exercise for cancer patients. This pathway intended to serve as an interface between oncological care and existing or developing exercise therapy services in the local area of the participating hospitals. Needs- and side-effect-oriented care pathways are intended to give as many patients as possible access to quality-assured exercise therapy services close to home and thus to the supportive potential of exercise. The new care pathway will be develop in year 1 (phase 1) and will be established at 7 Comprehensive Cancer Centers (CCCs) in 3 model regions Heidelberg-Frankfurt-Mainz, Dresden-Berlin and Freiburg-Tübingen (phase 2) in Germany, as well as adapted accordingly in organ cancer centers and with established oncological care providers (phase 3 - Outreach). The aim is to ensure that exercise promotion and therapy can be integrated into standard care as comprehensively and sustainably as possible. The implementation project will be evaluated according to the achievement of implementation and intervention goals. The implementation goals are utilization (reach) and actual implementation. Factors for successful implementation will be identified and incorporated into the procedure in phase 3 (outreach). Intervention goals are mapped at provider and patient level in both phases. They include improving physical functioning, increasing physical activity behavior, improving exercise-related health literacy, increasing motivation to exercise and increasing patient participation. For this purpose, patients with a cancer disease undergoing acute therapy aged 18 and over who are cared for in participating centers are surveyed four times over a period of 24 weeks using standardized questionnaires (baseline (t0) before the intervention, follow-up after 4 (t1), 12 (t2) and 24 (t3) weeks). In addition, the participating managers and service providers of the centers in phase 2 (implementation phase) and phase 3 (outreach phase) will be surveyed using standardized questionnaires and in-depth interviews. The longitudinal evaluation design enables an analysis of the changes in care structures and processes, the success of implementation and the experiences and outcomes of patients

Вмешательства

  • Поведенческое Exercise oncology counseling and referal
    Identification \& brief consultation Screening: Needs assessment for exercise therapy Information / educational talk Consultation with the patient Risk assessment (with physician clearance) Consultation Referral to exercise therapy

Первичные конечные точки

  • Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30 [Срок оценки: baseline till week 12 (& 12 week follow up)]
Вторичные конечные точки (9)
  • Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire [Срок оценки: baseline till week 12 (& 12 week follow up)]
  • Change from baseline to week 12 in physical activity-related health competence [Срок оценки: baseline till week 12 (& 12 week follow up)]
  • Change from baseline to week 12 in social support [Срок оценки: baseline till week 12 (& 12 week follow up)]
  • Change from baseline to week 12 in patient activation [Срок оценки: baseline till week 12 (& 12 week follow up)]
  • Patients' Experiences Across Health Care Sectors at week 12 [Срок оценки: week 12]
  • Patients' Shared Decision-Making experience at week 12 [Срок оценки: week 12]
  • Reasons for discontinuing physical/exercise therapy at week 12 and follow-up [Срок оценки: week 12 (& 12 week follow up)]
  • Cancer Patients Information Needs at week 12 and follow-up [Срок оценки: week 12 (& 12 week follow up)]
  • Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy [Срок оценки: baseline till week 12 (& 12 week follow up)]

Критерии участия

Inclusion Criteria (patients):

  • cancer patients during chemotherapy, immune therapy or radiotherapy
  • having symptoms/side effects that can be effectively treated by exercise (e.g. fatigue) and/or are interested in exercise oncology counseling

Inclusion Criteria (care providers)

\- involved in the implementation process

Exclusion Criteria (both):

\- Insufficient German language skills

Exclusion Criteria (care providers only):

\- Duration employed <6 months

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Германия · 7 центров
  • Universitätsklinikum Freiburg — Freiburg im Breisgau
  • Nationales Centrum für Tumorerkrankungen — Heidelberg
  • Medizinische Klinik der Universitätsklinikum Tübingen — Tübingen
  • Universitäres Centrum für Tumorekrankungen Frankfurt — Frankfurt am Main
  • Universitäres Centrum für Tumorerkrankungen Mainz — Mainz
  • Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC) — Dresden
  • Charité - Universitätsmedizin Berlin — Berlin

Публикации

  • Blutgen S, Tigges AL, Zinkevich A, Krug K, Wensing M, Graf K, Wiskemann J, Ansmann L; MOVE-ONKO Consortium. 'It only works if we coordinate our work, that's what we need': a relational qualitative network analysis of exercise therapy in oncology care in Germany. BMC Cancer. 2025 Nov 29;25(1):1845. doi: 10.1186/s12885-025-15326-y. PMID 41318435
  • Blutgen S, Krug K, Graf K, Betz U, Bohm J, Jager E, Krell V, Muller J, Pahl A, Voland A, Weigmann-Fassbender S, Zinkevich A, Wensing M, Ansmann L, Wiskemann J. Implementation and evaluation of a multi-professional care pathway and network for the promotion of needs-oriented, resident-oriented exercise therapy for oncological patients (MOVE-ONKO): protocol of a mixed-methods cohort study. BMC Cance PMID 40082847

Идентификаторы

NCT: NCT06185777 · S-571/2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗