Clinical trial NCT06768918: Digitizing Cancer Rehabilitation During and After Systemic Treatment: Feasibility Testing Implementation in South Baltic Countries
Official title: Digitizing Cancer Rehabilitation During and After Systemic Treatment: Feasibility Testing Implementation in South Baltic Countries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Rehabilitation
Cancer
Keywords: Remote physical rehabilitation
cancer rehabilitation
e-health
implementation
feasibility
acceptability
exercise
physiotherapy
home-based
oncology
usability
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Klaipėda University
name: University of Rostock
name: Angelholm Hospital
name: University Clinical Centre, Gdansk
First posted: 2025-01-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Detailed Description

Introduction

Increasing survival rates in cancer patients has put an increasing focus on physical rehabilitation in survivorship. Physical rehabilitation plays an important role in the cancer care continuum by improving Quality of Life, functional ability and participation in everyday life. Often, however, patients may be unable to participate due to barriers related to resources, social support, distance to facility, a heavy treatment schedule and dealing with side- or late effects of treatment. Physical rehabilitation during primary, neoadjuvant or adjuvant oncological treatment could prevent loss of muscle strength, maintain or even improve physical fitness, alleviate acute toxicities of chemotherapy like fatigue, pain, depression and nausea. When entering the survivorship phase, it is also well-documented that survivors have difficulties meeting recommendations for physical activity, and the negative consequences are reduced survival and increase risk of lifestyle diseases and systemic late effects after treatment. Although physical rehabilitation is already recommended in international clinical guidelines, it is far from implemented broadly. Further, current studies indicate that there is socioeconomic inequality in who participates in the rehabilitation on offer. One reason might be the rurality of certain regions, costing patients many resources in i.e. transportation. Other reasons may include lack of resources to participate, both timewise, but also related to psychological, physical and social demands. Digital solutions may be beneficial in solving many of the barriers to participation and be a way to deliver "precision rehabilitation"; the right mode and dose to individual patients, taking personal preference and resources into consideration and utilizing them.

This study aims to feasibility test implementation of digital rehabilitation in 5 rural countries in the South Baltic.

Methods

Trial design 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 setting and organization The current study is part of the Interreg South Baltic Program-funded project "AMBeR" (Advanced Modelling of Baltic cancer e-caRe). A total of seven partners from five countries are involved and are working on five different WP's. The following 5 of the 7 project partners are involved in the study (WP 4) are described here: 1) Angelholm Hospital, Region Scania, Sweden; 2) University Medical Center Rostock, Germany; 3) University Clinical Center Gdansk, Poland; 4) Klaipeda University, Lithuania; and 5) Zealand University Hospital, Denmark.

Each site will participate in the feasibility studies with á n=30:

1. early rehab (during systemic cancer treatment)
2. rehab@home (after completion of systemic cancer treatment).

Inclusion criteria

* ≥ 18 years
* Diagnosed with cancer (IDC: C00\* - C97\*)

Additionally, in 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.

In 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.

Eligible patients are patients that have physical or psychological rehabilitation needs and that would normally be referred to physiotherapy or similar exercise specialist in cancer care, either as per normal practice or according to international guidelines.

Eligible health Care professionals delivering the intervention are those who according to local practice and authorization deliver usual care to the target groups specific to each site.

Choosing a digital solution Health care professionals/physiotherapists and the local study group at each site will be involved in choosing the digital solution to be implemented, and each site will select a unique digital solution to meet their criteria and needs. The selection is based on availability on the local market, targeted population, language availability, objectivity of movement feedback, possibility for interaction, and features for progression and regression of treatment programme. Further the demands for integrating the solution into existing IT systems is also considered. The advantages/disadvantages and costs will be weighed before a solution is selected.

Implementation

* describing the existing care process and identifying stakeholders.
* describing new care process, stakeholders and pathways in the new practice.
* Workshop 1:" setting the scene" context mapping, barriers and facilitators, solution design, action plan. Participation from all relevant stakeholders identified through context mapping of the care process. A patient representative will be involved and engaged in workshop if at all possible, and thereby contribute with the patient perspective on barriers and facilitators.
* Education and preparing HCP's in use of the digital technology and integrating it into the "toolbox" and a new professional identity.
* Workshop 2 "facilitating/supporting the ongoing process" mid-study, dealing with challenges, adjusting design, plan and support further implementation.
* Workshop 3 "picking the fruits of best practice" post-study, including examining learnings from the feasibility studies and evaluating finalized, ongoing and planed implementation.
* A logbook describing the process, actions and rationale of all steps of the implementation will be used for documentation throughout the intervention phase.

Following workshop 1, pre-study identification of expected barriers and facilitators for patients to engage in remote physical rehabilitation will be carried out through 4 steps:

1. Summary from literature review and past experience.
2. Matching most important barriers with strategies using the ERIC matching tool
3. Ranking strategies according to effectiveness and importance in the clinical setting each site by members of the study team across sites
4. Building on strategies to make action plans for implementation of the intervention each site.

Assessing Patient's and HCP's perspectives on determinants

Towards the final phase of completing the feasibility studies, the perspectives of patients' and HCP's on the important determinants for engagement in remote physical rehabilitation will be examined, applying the technique of Group Concept Mapping. The process will follow 5 pre-described steps and all activity will be online utilizing the software "GroupwisdomTM":

1. Brainstorming
2. and 3) Sorting, labelling and rating

4) Generating a cluster rating map 5) Validation of the cluster rating map The process will be performed separately for patients and HCPs, inviting a representative sample of patients for one study and all participating Intervention delivering HCP´s for a second study. For the study where patients participate, there will be a translation process of all texts and prompts to the patients' own language and back again, for the researchers to process and analyze.

Quantitative outcomes The RE-AIM framework will be used for a systematic quantification of outcomes. A range of different outcomes, measurement methods and data sources will be used as outlined in outcome measures section. For the questionnaire all partners will translate a common questionnaire into their own language using a forward-backward translation process and pilot-testing the translated questionnaire on 5-8 patients.

Data collection and management A REDCap database will be created for all study outcomes and relevant data to be collected and safely stored.

All HCP's involved in data collection will undergo a thorough training and standardization program involving physical testing, patient-reported outcome collection, recording /database familiarization, and update on international clinical guidelines in cancer rehabilitation. Monthly audits will be carried out to secure rigorous data collection is homogeneous and follows protocol.

Participant and Non-participant questionnaires To obtain information about eligible patients who decline participation in remote physical rehabilitation, decliners will be invited to answer a short questionnaire, reporting on their characteristics, reasons for refusal and barriers for participation (see table 1, decliners). Those who accept participation will receive a larger questionnaire reporting further on Patient Reported Outcome Measures (PROMs) and Acceptability. PROMs and Acceptability scales outlined in Table 1 will be collected using validated questionnaires. If not available in the local language, a forward-backward translation will be carried out and validated in 2-4 patients.

Effectiveness evaluation At the initial consultation with a HCP, the patient and HCP together will set realistic goals for the intervention, using the Patient Specific Functional Scale (PSFS) to quantify meaningful functional goals relevant to the individual patient. As per usual care, these goals may be adjusted along the way according to the patient's health status development, and the number of times adjusted will be recorded in the database. At the beginning and the end of the intervention, the patient rates themselves on a 0-10 scale how close to reaching the goal they are, and a within-patient change score will be calculated.

Harms and drop-outs An ongoing and systematic registration of harms, drop-outs and reasons for drop-out, as well as if any of the aforementioned events are likely to be associated to the delivery method of the intervention will be recorded in the database on a day-to-day basis.

Economic/resource evaluation An economic analysis will be performed using collected process data evaluating time and resources used for the remote digital rehabilitation. Data in this evaluation will cover Administrative time and contact attempts, consultation time, physiotherapist/HCP's time used in preparation/tracking the patient progress, and patients transport time (saved).

Sample size in the feasibility trials Sample size of the feasibility trials was estimated based on considerations on ensuring sufficient gathering of experiences each site, backed up by literature on recommendations for sample size in pilot trials and feasibility studies. The decision from the consortium was 30 participants each site for each feasibility study, giving a total pooled sample of 30 participants x 2 feasibility studies x 5 sites = 300 participating patients in total. The number needed to screen and invite at each site will therefore be varying and these numbers will be recorded.

Relevant concomitant care Participants will be allowed to attend concomitant usual care supplemental rehabilitation for diagnosis specific needs that cannot be met by the involved health professional or with the digital tool selected. If a participant wishes to receive usual care instead of the intervention with digital rehabilitation, they will be put on the waiting list for that.

Statistical methods Mainly descriptive statistics will be used to analyze quantitative outcomes, although effectiveness will be assessed with a pre-post change score.

Ethics approval and consent to participate Ethics approval will be applied for in each participating country with local adaptions of this protocol.

Eligibility criteria: 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 outcomes:
measure: Patient's and therapist perspectives on determinants
timeFrame: 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:
measure: Educational level
timeFrame: Baseline
measure: Employment status
timeFrame: baseline
measure: Attendance rates
timeFrame: baseline to end intervention (8-12 weeks)
measure: Recruitment and referral rates
timeFrame: Baseline
measure: Adherence
timeFrame: Baseline to end of intervention (8-12 weeks)
measure: Number of monthly physical encounters between patient and therapist
timeFrame: During intervention (8-12 weeks)
measure: Health technology readiness
timeFrame: Assessed at one timepoint at inclusion into the study, before initiation of the intervention.
measure: Barriers for participation
timeFrame: Baseline
measure: Safety
timeFrame: During intervention (8-12 weeks)
measure: Acceptability
timeFrame: Post intervention
measure: Time consumption per patient
timeFrame: During intervention (8-12 weeks).
measure: Patient Specific Function Scale
timeFrame: Assessed pre- and post-intervention
measure: European Organization of Research and Treatment in Cancer, core module (C30)
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: European Organization of Research and Treatment in Cancer, fatigue module (FA12)
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: EQ-5D-5L
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: Step count, daily average
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: Gait speed
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: 30 second sit-to-stand
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: Timed up and go
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: Hand grip strength
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: Tandem test
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: 6-minute walk test
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: Watt max test
timeFrame: Assessed pre- and post-intervention (8-12 weeks)
measure: Cancer disease
timeFrame: baseline
measure: Body height
timeFrame: baseline
measure: Body weight
timeFrame: baseline
Locations:
city: Næstved
country: Denmark
facility: Zealand Unievrsity Hospital
city: Rostock
country: Germany
facility: University Medical Center Rostock
city: Klaipeda
country: Lithuania
facility: Klaipeda University
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Ängelholm
country: Sweden
facility: Ängelholm Hospital
Study officials:
affiliation: Zealand University Hospital, Department of Clinical Oncology and Palliative Care
name: Susanne O Dalton, MD PhD
role: PRINCIPAL_INVESTIGATOR
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