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Recruiting Not applicable

Digitizing Cancer Rehabilitation During and After Systemic Treatment: Feasibility Testing Implementation in South Baltic Countries

NCT06768918 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-10-03
Last updated
2026-03-12

Condition(s) studied

Cancer RehabilitationCancer

Investigational drug(s) / intervention(s)

remote physical rehabilitation

remote physical rehabilitation: In this multisite international study, we feasibility test implementation of 4 different digital solutions for delivering interactive physical rehabilitation during or after systemic anticancer treatment. The contents of the intervention follows international recommendations for exercise during or after treatment for cancer.

Study summary

Background

With increasing cancer incidence and advanced cancer treatment, the growing population of cancer survivors increases the demand on health resources worldwide. Over the last 20 years, physical rehabilitation has reached recognition as an essential component of cancer care due its effect on physical function, side effects of treatment, and quality of life. However, highly specialized health care can result in longer distances to rehabilitation facilities. Also, a heavy appointment schedule for patients in treatment tends to complicate participation in rehabilitation. Telehealth has shown promise in increasing accessibility to services, also rehabilitation. However, barriers to participating in digitally delivered rehabilitation might exist, including lower e-health literacy and internet access in rural areas. The aim of this study is therefore, to examine the feasibility of implementing digitally supported rehabilitaiton in cancer care during and after treatment.

Methodology In a multinational implementation study, the feasibility of implementation of digital rehabilitation will be tested in five South Baltic Countries (DK, SWE, GER, PL, LTU). Each site will host one feasibility trial for patients during cancer treatment and one for patients after, with n=30 patients in each fesibility trial (total n=300). The intervention will be needs-based, follow international guidelines, last from 8-16 weeks, and be delivered by trained Health Care Professionals (HCP's), either fully or partially digital. Mixed methods will be used to assess outcomes of reach, effectiveness, adoption, implementation and maintenance (RE-AIM).

Through the coordinated feasibility trials across five South Baltic countries, the investigators expect to learn about important factors in implementation of digitally delivered rehabilitation in different settings, cultures, and health systems. Finally, the investigators will bring recommendations for improving reach, implementation, and sustainability of digitally delivered rehabilitation across different settings.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosed with cancer (IDC: C00\* - C97\*) * Feasibility study 1 (early rehab): Participants should receive any systemic chemo/immunotherapy preferably (but not necessarily) with a duration of 8 weeks or more. Recruitment should be at earliest convenience preferably (but not necessarily) within 4 weeks of treatment initiation. * Feasibility study 2 (rehab@home): Participants should preferably have completed chemotherapy/immunotherapy no more than 6 months ago but may be receiving long-standing maintenance and life-prolonging chemo-/immunotherapy. Exclusion Criteria: \- Cognitively unable to give consent to, or participate in, a digital rehabilitation programme as judged by project team staff.

Primary outcome measure(s)

  • Patient's and therapist perspectives on determinants — Patients: between 4 and 12 weeks of intervention participation. Therapists: between 5 patient treatments completed and end of study (on average 1 year).
    2 Qualitative analyses using online Group Concept Mapping will be performed. One with 5-10 patients in their final phase of the rehabilitation program (minimum 1 participant each country), and one with 5-10 therapists/health professionals (minimum one each country). One -two promps phrased to create responses from informants about what the determinants are for engaging in digital e-rehabilitation, will be specified by the project group in collaboration. The process will further follow 5 pre-described steps of online activities, utilizing the software "GroupwisdomTM", The steps are as follows: Step 1) Brainstorming the prompt(s) Steps 2 and 3) Sorting, labelling and rating Step 4) Generating a cluster rating map Step 5) Validation of the cluster rating map We will perform the process separately for patients and therapists.

Trial sites (5)

FacilityCityRegionStatus
Zealand Unievrsity Hospital Næstved Denmark Recruiting
University Medical Center Rostock Rostock Germany Recruiting
Klaipeda University Klaipėda Lithuania Recruiting
Medical University of Gdansk Gdansk Poland Recruiting
Ängelholm Hospital Ängelholm Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06768918 on ClinicalTrials.gov ↗ ← All trials in Denmark