跳至主要内容
临床试验/NCT06496711
NCT06496711招募中不适用

IMPLEMENT - Model Project for the Cross-sector Implementation of a Comprehensive and Quality-assured Sports and Exercise Therapy for Cancer Patients

University of Cologne2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
Primary Outcome: Increase oncology patients participating in quality-assured exercise therapy

研究概览

简要总结

IMPLEMENT aims to develop, test and establish a sustainable access structure for quality-assured oncological exercise therapy (qOET) in Germany as a model within the funding period of three years. This will be done in three phases:

Phase 1: In the first step, a characterization of the existing implementation structures and the existing barriers and needs as well as the establishment of the cooperation with the most important actors in the care system will take place.

Phase 2: In the subsequent implementation process, concrete measures are practically implemented in subprojects for specific target groups (children/adolescents, adults) and specific regions (rural, urban) as well as the digital solutions and interface management. With the help of a mixed-methods design, the barriers and facilitating factors of the implementation of area-wide qSBT will be investigated during the project and fed into a "learning system" for adaptation and improvement.

Phase 3: The success of the measures to increase patient participation in qOET and the development of the structures as well as the barrier and facilitating factors for an effective implementation will be addressed in a before-after comparison through evaluation steps and an economic accompanying evaluation will be carried out.

详细描述

IMPLEMENT is an exploratory, open-label, non-randomized, mixed-methods study. No additional treatments or therapies that can influence the course of the disease are provided to the participating patients. Rather, various implementation strategies will be developed to bring more patients into the existing quality-assures oncological exercise therapy (qOET), to further develop other exercise and sports offers for qOET or to create completely new offers of qOET. The implementation strategies are examined with regard to their degree of effectiveness. The effectiveness is determined by means of a before-and-after comparison (e.g. number of patients in qOET at baseline) and, if applicable, with comparable studies. IMPLEMENT is evaluated using the RE-AIM framework. The aim of the data collection carried out in IMPLEMENT is to provide the necessary data for the evaluation with RE-AIM on the one hand, and to provide information for the development and adaptation of suitable implementation strategies on the other.

Risks to achieving the objectives include the willingness of patients to participate in qOET and the willingness of doctors, therapists and other people working in oncological care to implement the interventions and to expand and adapt their professional activities accordingly. To address these challenges, a mixed-methods approach is used to identify barriers and facilitators. A mixed-methods approach enables a theoretical understanding of the implementation process and provides a more comprehensive picture of the factors relevant to successful implementation than qualitative or exclusively quantitative methods alone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cancer
  • Healthcare providers (e.g. Medical Doctors, physiotherapists, nurses, psychologists) involved in the treatment and/or counseling of cancer patients, including aftercare.
  • Exclusion Criteria (Cancer Patients):
  • Psychological and/or physical limitations that do not allow participation in quality-assured sports and exercise therapy (e.g. unstable cardiac arrhythmias)

排除标准

  • 未提供

结局指标

主要结局

Primary Outcome: Increase oncology patients participating in quality-assured exercise therapy

时间窗: Baseline (M1), one year (M2) and 2 years (M3)

The primary outcome of the IMPLEMENT project is an increase in the number of oncology patients participating in quality-assured sports and exercise therapy (median 30%). The primary outcome is measured by the RE-AIM (Reach) questionnaire in a semi-structured personal interview three times.

次要结局

  • SO2. Patient-related effectiveness(Baseline (M1), one year (M2) and 2 years (M3))
  • SO1. Adoption/acceptance(Baseline (M1), one year (M2) and 2 years (M3))
  • SO4. Maintenance(Baseline (M1), one year (M2) and 2 years (M3))
  • SO3. Consistency of implementation(Baseline (M1), one year (M2) and 2 years (M3))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Freerk Baumann; Prof. Dr.

Prof. Dr. Freerk Baumann

University of Cologne

研究点 (2)

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