. 2021 May 28;11(5):e043224.

doi: 10.1136/bmjopen-2020-043224.

eTRIO trial: study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology

Ilona Juraskova¹, R Laidsaar-Powell², Rachael Keast², Penelope Schofield^{3

4

5}, Daniel Sj Costa^{6

7}, Judy Kay⁸, Sandra Turner^{9

10}, Bogda Koczwara¹¹, Christobel Saunders¹², Michael Jefford^{13

14}, Patsy Yates¹⁵, Frances Boyle^{10

16}, Kate White¹⁷, Annie Miller¹⁸, Rachael L Morton¹⁹, Zoe Butt², Phyllis Butow²

Affiliations

¹ School of Psychology, Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Faculty of Science, Camperdown, New South Wales, Australia ilona.juraskova@sydney.edu.au.
² School of Psychology, Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Faculty of Science, Camperdown, New South Wales, Australia.
³ Department of Psychology, and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, Victoria, Australia.
⁴ Behavioural Sciences Unit, Health Services Research and Implementation Sciences, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
⁵ Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia.
⁶ Pain Management Research Institute, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
⁷ School of Psychology, The University of Sydney, Camperdown, New South Wales, Australia.
⁸ School of Computer Science, The University of Sydney, Faculty of Engineering, Sydney, New South Wales, Australia.
⁹ Department of Radiation Oncology, Westmead Hospital, Westmead, New South Wales, Australia.
¹⁰ Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
¹¹ Flinders University School of Medicine, Adelaide, South Australia, Australia.
¹² Division of Surgery, School of Medicine, The University of Western Australia, Perth, Western Australia, Australia.
¹³ Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.
¹⁴ Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
¹⁵ Centre for Cancer and Palliative Care Outcomes, Queensland University of Technology, Kelvin Grove, Queensland, Australia.
¹⁶ Patricia Ritchie Centre for Cancer Care & Research, Mater Hospital, Sydney, New South Wales, Australia.
¹⁷ Susan Wakil School of Nursing and Midwifery, Cancer Nursing Research Unit, University of Sydney, Faculty of Medicine and Health, Camperdown, New South Wales, Australia.
¹⁸ Cancer Information and Support Services Division, Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia.
¹⁹ NHMRC Clinical Trials Centre, The University of Sydney, Faculty of Medicine and Health, Camperdown, New South Wales, Australia.

PMID: 34049902
PMCID: PMC8166623
DOI: 10.1136/bmjopen-2020-043224

eTRIO trial: study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology

Ilona Juraskova et al. BMJ Open. 2021.

. 2021 May 28;11(5):e043224.

doi: 10.1136/bmjopen-2020-043224.

Authors

Affiliations

¹ School of Psychology, Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Faculty of Science, Camperdown, New South Wales, Australia ilona.juraskova@sydney.edu.au.
² School of Psychology, Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Faculty of Science, Camperdown, New South Wales, Australia.
³ Department of Psychology, and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, Victoria, Australia.
⁴ Behavioural Sciences Unit, Health Services Research and Implementation Sciences, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
⁵ Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, Victoria, Australia.
⁶ Pain Management Research Institute, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
⁷ School of Psychology, The University of Sydney, Camperdown, New South Wales, Australia.
⁸ School of Computer Science, The University of Sydney, Faculty of Engineering, Sydney, New South Wales, Australia.
⁹ Department of Radiation Oncology, Westmead Hospital, Westmead, New South Wales, Australia.
¹⁰ Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
¹¹ Flinders University School of Medicine, Adelaide, South Australia, Australia.
¹² Division of Surgery, School of Medicine, The University of Western Australia, Perth, Western Australia, Australia.
¹³ Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Victoria, Australia.
¹⁴ Department of Health Services Research, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
¹⁵ Centre for Cancer and Palliative Care Outcomes, Queensland University of Technology, Kelvin Grove, Queensland, Australia.
¹⁶ Patricia Ritchie Centre for Cancer Care & Research, Mater Hospital, Sydney, New South Wales, Australia.
¹⁷ Susan Wakil School of Nursing and Midwifery, Cancer Nursing Research Unit, University of Sydney, Faculty of Medicine and Health, Camperdown, New South Wales, Australia.
¹⁸ Cancer Information and Support Services Division, Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia.
¹⁹ NHMRC Clinical Trials Centre, The University of Sydney, Faculty of Medicine and Health, Camperdown, New South Wales, Australia.

PMID: 34049902
PMCID: PMC8166623
DOI: 10.1136/bmjopen-2020-043224

Abstract

Objective: Informal family caregivers play a crucial role in cancer care. Effective caregiver involvement in cancer care can improve both patient and caregiver outcomes. Despite this, interventions improving the caregiver involvement are sparse. This protocol describes a randomised controlled trial evaluating the combined effectiveness of novel online caregiver communication education modules for: (1) oncology clinicians (eTRIO) and (2) patients with cancer and caregivers (eTRIO-pc).

Methods and analysis: Thirty medical/radiation/surgical oncology or haematology doctors and nurses will be randomly allocated to either intervention (eTRIO) or control (an Australian State Government Health website on caregivers) education conditions. Following completion of education, each clinician will recruit nine patient-caregiver pairs, who will be allocated to the same condition as their recruiting clinician. Eligibility includes any new adult patient diagnosed with any type/stage cancer attending consultations with a caregiver. Approximately 270 patient-caregiver pairs will be recruited. The primary outcome is caregiver self-efficacy in triadic (clinician-patient-caregiver) communication. Patient and clinician self-efficacy in triadic communication are secondary outcomes. Additional secondary outcomes for clinicians include preferences for caregiver involvement, perceived module usability/acceptability, analysis of module use, satisfaction with the module, knowledge of strategies and feedback interviews. Secondary outcomes for caregivers and patients include preferences for caregiver involvement, satisfaction with clinician communication, distress, quality of life, healthcare expenditure, perceived module usability/acceptability and analysis of module use. A subset of patients and caregivers will complete feedback interviews. Secondary outcomes for caregivers include preparedness for caregiving, patient-caregiver communication and caring experience. Assessments will be conducted at baseline, and 1 week, 12 weeks and 26 weeks post-intervention.

Ethics and dissemination: Ethical approval has been received by the Sydney Local Health District Human Research Ethics Committee (REGIS project ID number: 2019/PID09787), with site-specific approval from each recruitment site. Protocol V.7 (dated 1 September 2020) is currently approved and reported in this manuscript. Findings will be disseminated via presentations and peer-reviewed publications. Engagement with clinicians, media, government, consumers and peak cancer groups will facilitate widespread dissemination and long-term availability of the educational modules.

Trial registration number: ACTRN12619001507178.

Keywords: medical education & training; oncology; world wide web technology.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
*eTRIO* trial study design.

**Figure 2**
Standard Protocol Items: Recommendations for Interventional Trials schedule of enrolment, interventions and assessments for participating *caregivers.*

**Figure 3**
Standard Protocol Items: Recommendations for Interventional Trials schedule of enrolment, interventions and assessments for oncology *clinicians.*

**Figure 4**
Standard Protocol Items: Recommendations for Interventional Trials schedule of enrolment, interventions and assessments for participating *patients*.

See this image and copyright information in PMC

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References

1. Laidsaar-Powell RC, Butow PN, Bu S, et al. . Physician-patient-companion communication and decision-making: a systematic review of triadic medical consultations. Patient Educ Couns 2013;91:3–13. 10.1016/j.pec.2012.11.007 - DOI - PubMed
1. Laidsaar-Powell R, Butow P, Bu S, et al. . Attitudes and experiences of family involvement in cancer consultations: a qualitative exploration of patient and family member perspectives. Support Care Cancer 2016;24:4131–40. 10.1007/s00520-016-3237-8 - DOI - PubMed
1. Dionne-Odom JN, Ejem D, Wells R, et al. . How family caregivers of persons with advanced cancer assist with upstream healthcare decision-making: a qualitative study. PLoS One 2019;14:e0212967. 10.1371/journal.pone.0212967 - DOI - PMC - PubMed
1. Roter DL, Narayanan S, Smith K, et al. . Family caregivers' facilitation of daily adult prescription medication use. Patient Educ Couns 2018;101:908–16. 10.1016/j.pec.2017.12.018 - DOI - PubMed
1. Thomas C, Morris SM, Harman JC. Companions through cancer: the care given by informal carers in cancer contexts. Soc Sci Med 2002;54:529–44. 10.1016/s0277-9536(01)00048-x - DOI - PubMed

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eTRIO trial: study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology

Affiliations

eTRIO trial: study protocol of a randomised controlled trial of online education modules to facilitate effective family caregiver involvement in oncology

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Abstract

Conflict of interest statement

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