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

Cancer Clinical Trial

— MOVE-ONKO  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06185777
• Other study ID #: S-571/2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: December 2023
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2500
• Est. completion date: October 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Exercise
• Implementation

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC)	Dresden	Sachsen
Germany	Universitäres Centrum für Tumorekrankungen Frankfurt	Frankfurt	Hessen
Germany	Universitätsklinikum Freiburg	Freiburg	Baden-Württemberg
Germany	Nationales Centrum für Tumorerkrankungen	Heidelberg	Baden-Württemberg
Germany	Universitäres Centrum für Tumorerkrankungen Mainz	Mainz	Rheinland-Pfalz
Germany	Medizinische Klinik der Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30	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)	baseline till week 12 (& 12 week follow up)
Secondary	Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire	The Godin Leisure-Time Exercise Questionnaire assesses self-reported physical activity (PA) among adults in minutes per week (3 intensity categories: low, moderate, vigorous)	baseline till week 12 (& 12 week follow up)
Secondary	Change from baseline to week 12 in physical activity-related health competence	The questionnaire is based on the physical activity-related health competence (PAHCO) model by Sudeck and Pfeifer et al. 2016 and supposed to assess specific facets of the PAHCO, specifically addressing an individual's aptitude to effectively utilize physical activity to optimize their overall health. The questionnaire consists of 13 items comprised of three latent factors: PA-specific mood regulation (MR) (four items), control competence for physical training (CC) (six items) and PA specific self-control (SC) (three items)	baseline till week 12 (& 12 week follow up)
Secondary	Change from baseline to week 12 in social support	The Modified Medical Outcomes Study Social Support Survey (mMOS-SS) is an 8-item self-reported measure of individual experience of social support, with two subscale measures of emotional support, and instrumental support. Items ask respondents about having someone to help with physical needs, and emotional assistance. The mMOS-SS is an abbreviated adaptation of the original 19-item	baseline till week 12 (& 12 week follow up)
Secondary	Change from baseline to week 12 in patient activation	PAM is a validated questionnaire designed to measure the knowledge, skills and confidence that a person has to manage their own wellbeing (patient activation).	baseline till week 12 (& 12 week follow up)
Secondary	Patients' Experiences Across Health Care Sectors at week 12	The Patients' Experiences Across Health Care Sectors (PEACS) questionnaire is a validated questionnaire to asses patient orientation in a fragmented health-care system	week 12
Secondary	Patients' Shared Decision-Making experience at week 12	The 9-item Shared Decision Making Questionnaire was developed in a theory-driven manner and measures the extent to which patients are involved in the process of decision-making from the perspective of the patient (patient version SDM-Q-9) and from the perspective of the physician (physician version SDM-Q-Doc). The measure was developed for use in research and clinical practice.	week 12
Secondary	Reasons for discontinuing physical/exercise therapy at week 12 and follow-up	The Problematic Experiences of Therapy Scale (PETS; Kirby, Donovan-Hall, & Yardley, 2014) is a brief measure that was developed based on clinical experience and research to reflect the most commonly reported reasons for discontinuing physical therapy given by patients undergoing self-managed home-based rehabilitation. he PETS comprises 12 Likert-scaled items divided into four subscales: 1. Symptoms too severe or aggravated by therapy (items 1-3), 2. Uncertainty about how to carry out the treatment (items 4-5), 3. Doubts about treatment efficacy (items 6-8), and 4. Practical problems (items 9-12). Each item asks respondents the extent to which they agree that they have been prevented from carrying out an intervention by plausible reasons.	week 12 (& 12 week follow up)
Secondary	Cancer Patients Information Needs at week 12 and follow-up	Cancer Patients Information Needs" scale is a validated 17-item questionnaire (Mesters et al. 2001) assessing the various needs of cancer patients during and after cancer treatment	week 12 (& 12 week follow up)
Secondary	Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy	Various measures specific to the implemented intervention	baseline till week 12 (& 12 week follow up)

External Links

•   Project Website (in German only)