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NCT Number: NCT06185777

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Freiburg, Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise oncology counseling and referal

Behavioral

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

Primary outcomes

  1. 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

  1. Change from baseline to week 12 in physical activity measured by the Godin-Shephard Leisure Time Physical Activity Questionnaire

    Time frame: baseline till week 12 (& 12 week follow up)

    The Godin Leisure-Time Exercise Questionnaire assesses self-reported physical activity (PA) among adults in minutes per week (3 intensity categories: low, moderate, vigorous)

  2. Change from baseline to week 12 in physical activity-related health competence

    Time frame: baseline till week 12 (& 12 week follow up)

    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)

  3. Change from baseline to week 12 in social support

    Time frame: baseline till week 12 (& 12 week follow up)

    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

  4. Change from baseline to week 12 in patient activation

    Time frame: baseline till week 12 (& 12 week follow up)

    PAM is a validated questionnaire designed to measure the knowledge, skills and confidence that a person has to manage their own wellbeing (patient activation).

  5. Patients' Experiences Across Health Care Sectors at week 12

    Time frame: 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

  6. Patients' Shared Decision-Making experience at week 12

    Time frame: 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.

  7. Reasons for discontinuing physical/exercise therapy at week 12 and follow-up

    Time frame: week 12 (& 12 week 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.

  8. Cancer Patients Information Needs at week 12 and follow-up

    Time frame: week 12 (& 12 week 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

  9. Qualitative interviews and quantitative assessments with the RE-AIM framework to assess quality of pathway structure, processes and efficacy

    Time frame: baseline till week 12 (& 12 week follow up)

    Various measures specific to the implemented intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Joachim Wiskemann, Prof

CONTACT

[email protected]

+49 6221 565904

Julia Albrecht, Dr

CONTACT

[email protected]

+49 6221 56-32630

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Acronym: MOVE-ONKO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 29, 2023
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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