Clinical trial NCT06185777: Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients
Official title: Multi-professional Care Pathway and Network for the Promotion of Needs-oriented, Resident-oriented Exercise Therapy for Oncological Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Exercise
Implementation
Keywords: Cancer
Cancer treatment
Exercise
Physical Activity
Counseling
Cancer Care
Implementation
Nursing
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to week 12 in physical function measured by the EORTC QLQ-C30
timeFrame: baseline till week 12 (& 12 week follow up)
Secondary outcomes:
measure: Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire
timeFrame: baseline till week 12 (& 12 week follow up)
measure: Change from baseline to week 12 in physical activity-related health competence
timeFrame: baseline till week 12 (& 12 week follow up)
measure: Change from baseline to week 12 in social support
timeFrame: baseline till week 12 (& 12 week follow up)
measure: Change from baseline to week 12 in patient activation
timeFrame: baseline till week 12 (& 12 week follow up)
measure: Patients' Experiences Across Health Care Sectors at week 12
timeFrame: week 12
measure: Patients' Shared Decision-Making experience at week 12
timeFrame: week 12
measure: Reasons for discontinuing physical/exercise therapy at week 12 and follow-up
timeFrame: week 12 (& 12 week follow up)
measure: Cancer Patients Information Needs at week 12 and follow-up
timeFrame: week 12 (& 12 week follow up)
measure: Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy
timeFrame: baseline till week 12 (& 12 week follow up)
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
state: Baden-Württemberg
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Medizinische Klinik der Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Frankfurt
country: Germany
facility: Universitäres Centrum für Tumorekrankungen Frankfurt
state: Hessen
city: Mainz
country: Germany
facility: Universitäres Centrum für Tumorerkrankungen Mainz
state: Rheinland-Pfalz
city: Dresden
country: Germany
facility: Nationales Centrum für Tumorerkrankungen Dresden (NCT/UCC)
state: Sachsen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References: