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      Efficacy of Group Exercise–Based Cancer Rehabilitation Delivered via Telehealth (TeleCaRe): Protocol for a Randomized Controlled Trial

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          Abstract

          Background

          Access to rehabilitation to support cancer survivors to exercise is poor. Group exercise–based rehabilitation may be delivered remotely, but no trials have currently evaluated their efficacy.

          Objective

          We aimed to evaluate the efficacy of a group exercise–based cancer rehabilitation program delivered via telehealth compared to usual care for improving the quality of life of cancer survivors.

          Methods

          A parallel, assessor-blinded, pragmatic randomized controlled trial with embedded cost and qualitative analysis will be completed. In total, 116 cancer survivors will be recruited from a metropolitan health network in Melbourne, Victoria, Australia. The experimental group will attend an 8-week, twice-weekly, 60-minute exercise group session supervised via videoconferencing supplemented by a web-based home exercise program and information portal. The comparison group will receive usual care including standardized exercise advice and written information. Assessments will be completed at weeks 0 (baseline), 9 (post intervention), and 26 (follow-up). The primary outcome will be health-related quality of life measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire at week 9. Secondary measures include walking capacity (6-minute walk test), physical activity (activPAL accelerometer), self-efficacy (Health Action Process Approach Questionnaire), and adverse events. Health service data including hospital length of stay, hospital readmissions, and emergency department presentations will be recorded. Semistructured interviews will be completed within an interpretive description framework to explore the patient experience. The primary outcome will be analyzed using linear mixed effects models. A cost-effectiveness analysis will also be performed.

          Results

          The trial commenced in April 2022. As of June 2022, we enrolled 14 participants.

          Conclusions

          This trial will inform the future implementation of cancer rehabilitation by providing important data about efficacy, safety, cost, and patient experience.

          Trial Registration

          Australian New Zealand Clinical Trials Registry ACTRN12621001417875; https://tinyurl.com/yc5crwtr

          International Registered Report Identifier (IRRID)

          PRR1-10.2196/38553

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          Most cited references50

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          Using thematic analysis in psychology

          Virginia Braun, Victoria Clarke (2014)
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            Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

            A Tong, P SAINSBURY, J. Craig (2007)
            Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. To develop a checklist for explicit and comprehensive reporting of qualitative studies (in depth interviews and focus groups). We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.
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              Saturation in qualitative research: exploring its conceptualization and operationalization

              Benjamin Saunders, Julius Sim, Tom Kingstone … (2017)
              Saturation has attained widespread acceptance as a methodological principle in qualitative research. It is commonly taken to indicate that, on the basis of the data that have been collected or analysed hitherto, further data collection and/or analysis are unnecessary. However, there appears to be uncertainty as to how saturation should be conceptualized, and inconsistencies in its use. In this paper, we look to clarify the nature, purposes and uses of saturation, and in doing so add to theoretical debate on the role of saturation across different methodologies. We identify four distinct approaches to saturation, which differ in terms of the extent to which an inductive or a deductive logic is adopted, and the relative emphasis on data collection, data analysis, and theorizing. We explore the purposes saturation might serve in relation to these different approaches, and the implications for how and when saturation will be sought. In examining these issues, we highlight the uncertain logic underlying saturation—as essentially a predictive statement about the unobserved based on the observed, a judgement that, we argue, results in equivocation, and may in part explain the confusion surrounding its use. We conclude that saturation should be operationalized in a way that is consistent with the research question(s), and the theoretical position and analytic framework adopted, but also that there should be some limit to its scope, so as not to risk saturation losing its coherence and potency if its conceptualization and uses are stretched too widely.
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                Author and article information

                Contributors
                Amy M Dennett:
                ORCID: https://orcid.org/0000-0002-4690-7949
                Allied Health Clinical Research OfficeEastern HealthLevel 25 Arnold StBox Hill, 3128Australia61 390952442a.dennett@latrobe.edu.au
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: July 2022
                Publication date (Electronic): 18 July 2022
                Volume: 11
                Issue: 7
                Electronic Location Identifier: e38553
                Affiliations
                [1 ] Allied Health Clinical Research Office Eastern Health Box Hill Australia
                [2 ] School of Allied Health, Human Services and Sport La Trobe University Bundoora Australia
                [3 ] Community Health Eastern Health Healesville Australia
                [4 ] Department of Cancer Services Eastern Health Box Hill Australia
                [5 ] Eastern Health Clinical School Monash University Clayton Australia
                [6 ] School of Health Sciences Western Sydney University Campbelltown Australia
                Author notes
                Corresponding Author: Amy M Dennett a.dennett@ 123456latrobe.edu.au
                Author information
                https://orcid.org/0000-0002-4690-7949
                https://orcid.org/0000-0003-0207-7071
                https://orcid.org/0000-0002-0686-7436
                https://orcid.org/0000-0002-6840-2378
                https://orcid.org/0000-0002-3545-5094
                https://orcid.org/0000-0003-1238-1288
                https://orcid.org/0000-0003-0096-7601
                https://orcid.org/0000-0002-2837-0973
                https://orcid.org/0000-0001-9474-2504
                Article
                Publisher ID: v11i7e38553
                DOI: 10.2196/38553
                PMC ID: 9345024
                PubMed ID: 35849441
                SO-VID: c8c42818-79a0-4441-aaed-ad43a6ed0734
                Copyright © ©Amy M Dennett, Katherine E Harding, Casey L Peiris, Nora Shields, Christian Barton, Lauren Lynch, Phillip Parente, David Lim, Nicholas F Taylor. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 18.07.2022.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                Date received : 6 April 2022
                Date revision requested : 3 June 2022
                Date revision received : 9 June 2022
                Date accepted : 16 June 2022
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: telehealth,exercise,telerehabilitation,physical activity,supportive care,cancer
                Data availability:
                Keywords: telehealth, exercise, telerehabilitation, physical activity, supportive care, cancer

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