Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 2,500
- Locations
- 7
- Primary Endpoint
- Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Insufficient German language skills
- •Exclusion Criteria (care providers only):
- •Duration employed <6 months
Arms & Interventions
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
Intervention: Exercise oncology counseling and referal (Behavioral)
Outcomes
Primary Outcomes
Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30
Time Frame: baseline till week 12 (& 12 week follow up)
Physical Function will be assessed within the validated 30-item self-assessment questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30, version 3.0). It comprises five multi-item functional scales (physical, role, emotional, cognitive, and social function), three multi-item symptom scales (fatigue, pain, nausea/vomiting), and six single items assessing further symptoms (dyspnea, insomnia, appetite loss, constipation, diarrhea) and financial difficulties. Scores range from 0 to 100. A higher score for the functional scales and global health status denote a better level of functioning, whereas a high score for symptom/single-item scale indicate a higher level of symptomatology/problems. Change = (Week 12 Score - Baseline Score)
Secondary Outcomes
- Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire(baseline till week 12 (& 12 week follow up))
- Change from baseline to week 12 in social support(baseline till week 12 (& 12 week follow up))
- Reasons for discontinuing physical/exercise therapy at week 12 and follow-up(week 12 (& 12 week follow up))
- Cancer Patients Information Needs at week 12 and follow-up(week 12 (& 12 week follow up))
- Change from baseline to week 12 in patient activation(baseline till week 12 (& 12 week follow up))
- Change from baseline to week 12 in physical activity-related health competence(baseline till week 12 (& 12 week follow up))
- Patients' Experiences Across Health Care Sectors at week 12(week 12)
- Patients' Shared Decision-Making experience at week 12(week 12)
- Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy(baseline till week 12 (& 12 week follow up))
Investigators
Joachim Wiskemann
Prof. Dr. Joachim Wiskemann
University Hospital Heidelberg