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

NCT06768918 | Recruiting

• 1 other identifier: p-2024-17503
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 5

Brief 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.

Conditions

Cancer Rehabilitation; Cancer

Keywords

Remote physical rehabilitation; cancer rehabilitation; e-health; implementation; feasibility; acceptability; exercise; physiotherapy; home-based; oncology; usability

Outcome Measures

Primary Outcomes (1)

• Patient's and therapist perspectives on determinants

  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.

  Patients: between 4 and 12 weeks of intervention participation. Therapists: between 5 patient treatments completed and end of study (on average 1 year).

Other Outcomes (26)

• Educational level

  Baseline

• Employment status

  baseline

• Attendance rates

  baseline to end intervention (8-12 weeks)

Study Arms (1)

Digital physical rehabilitation

EXPERIMENTAL

Feasibility testing the implementation of digitally delivered physical rehabilitation a) during systemic anticancer treatment and b) after completion of systemic anticancer treatment

Other: remote physical rehabilitation

Interventions

remote physical rehabilitation OTHER

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.

Also known as: physiotherapy, exercise, rehabilitation, e-rehabilitation

Digital physical rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Cognitively unable to give consent to, or participate in, a digital rehabilitation programme as judged by project team staff.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Klaipėda University: collaborator
• University of Rostock: collaborator
• Angelholm Hospital: collaborator
• University Clinical Centre, Gdansk: collaborator

Study Sites (5)

Zealand Unievrsity Hospital

Næstved, 4700, Denmark

RECRUITING

University Medical Center Rostock

Rostock, 18057, Germany

RECRUITING

Klaipeda University

Klaipėda, LT-92294, Lithuania

RECRUITING

Medical University of Gdansk

Gdansk, 80-210, Poland

RECRUITING

Ängelholm Hospital

Ängelholm, 26281, Sweden

RECRUITING

Related Publications (17)

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  PMID: 37990337 BACKGROUND

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  BACKGROUND

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  PMID: 25889199 BACKGROUND

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  PMID: 36899469 BACKGROUND

• Sweegers MG, Altenburg TM, Chinapaw MJ, Kalter J, Verdonck-de Leeuw IM, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, Brug J, Buffart LM. Which exercise prescriptions improve quality of life and physical function in patients with cancer during and following treatment? A systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2018 Apr;52(8):505-513. doi: 10.1136/bjsports-2017-097891. Epub 2017 Sep 27.

  PMID: 28954800 BACKGROUND

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  PMID: 33761906 BACKGROUND

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  PMID: 31013279 BACKGROUND

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  PMID: 34510366 BACKGROUND

• Cormie P, Atkinson M, Bucci L, Cust A, Eakin E, Hayes S, McCarthy S, Murnane A, Patchell S, Adams D. Clinical Oncology Society of Australia position statement on exercise in cancer care. Med J Aust. 2018 Aug 20;209(4):184-187. doi: 10.5694/mja18.00199. Epub 2018 May 7.

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• Ligibel JA, Bohlke K, May AM, Clinton SK, Demark-Wahnefried W, Gilchrist SC, Irwin ML, Late M, Mansfield S, Marshall TF, Meyerhardt JA, Thomson CA, Wood WA, Alfano CM. Exercise, Diet, and Weight Management During Cancer Treatment: ASCO Guideline. J Clin Oncol. 2022 Aug 1;40(22):2491-2507. doi: 10.1200/JCO.22.00687. Epub 2022 May 16.

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  PMID: 31626056 BACKGROUND

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Related Links

• Homepage for the AMBeR project, of which the AMBeR eRehab is a work package and separately registered study.

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Physical Therapy Modalities; Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Susanne O Dalton, MD PhD

  Zealand University Hospital, Department of Clinical Oncology and Palliative Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunn Ammitzbøll, PhD

CONTACT

+ 45 22 46 27 33; gai@regionsjaelland.dk

susanne O Dalton, PhD

CONTACT

+ 45 35 25 76 18; sdalt@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a multinational multisite feasibility study of the implementation of digitally supported physical rehabilitation in five South Baltic countries (DK, PL, GER, SWE, LTU) during systemic treatment (feasibility study 1) and after systemic treatment (feasibility study 2). The feasibility studies will be run as one-arm intervention studies.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: January 10, 2025
• Study Start: October 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

DE (1); DK (1); PL (1); SE (1); LI (1)