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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • remote physical rehabilitation

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Digital physical rehabilitationExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

1

Educational level

International Standard Classification of Education (ISCED) ISCED 0 = Early childhood education ISCED 1 = Primary Education ISCED 2 = Lower Secondary Education ISCED 3 = Upper Secondary Education ISCED 4 = Post-secondary non-Tertiary Education ISCED 5 = Short-cycle tertiary education ISCED 6 = Bachelors degree or equivalent tertiary education level ISCED 7 = Masters degree or equivalent tertiary education level ISCED 8 = Doctoral degree or equivalent tertiary education level

Time frame
Baseline
2

Employment status

a) Full time, b) part time, c) self-employed, d) unemployed seeking work, e) unemployed not seeking work, f) student, g) retired, h) unable to work, i) other.

Time frame
baseline
3

Attendance rates

Number of attended/performed sessions versus number of prescribed sessions

Time frame
baseline to end intervention (8-12 weeks)
4

Recruitment and referral rates

Number of referrals, number of enrolled vs. declined.

Time frame
Baseline

Sponsors and contacts

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Zealand University Hospital

Lead sponsor

Klaipėda University

Collaborator

University of Rostock

Collaborator

Angelholm Hospital

Collaborator

University Clinical Centre, Gdansk

Collaborator