The effect of internet-administered support (carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer compared with support as usual: a study protocol for a randomized controlled trial.

Anna Henriksson, Ylva Tiblom Ehrsson, Ulrica Langegård, Emma Ohlsson-Nevo, Per Fransson, Birgitta Johansson, Awais Ahmad, Åsa Cajander, Brith Granström, Louise von Essen, Mona Pettersson

Journal: BMC cancer 2024;24(1):494

PMID: 38637744

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Abstract

BACKGROUND

Informal caregivers (ICs) of patients with cancer provide essential and mainly uncompensated care. A self-perceived preparedness to care for the patient is associated with a lower caregiver burden, described as the extent to which caregiving is perceived as having adverse effects on IC functioning and well-being. ICs' well-being is associated with patient-perceived quality of care, suggesting that interventions to optimize ICs' health are essential in order to improve patient care. Head and neck cancer (HNC) is the seventh most common malignant disease in the world. The disease and its treatment have a significant negative impact on the patient's health and quality of life. Symptoms usually interfere with swallowing, food and fluid intake, breathing, speaking, and communication. ICs frequently manage patients' symptoms and side effects, especially problems related to nutrition and oral pain, without being properly prepared. Carer eSupport is an Internet-administered intervention, based on focus group discussions with ICs, developed in collaboration with ICs and healthcare professionals, tested for feasibility, and deemed feasible. This study protocol outlines the methods of investigating the effects of Carer eSupport plus support as usual (SAU) on self-reported preparedness for caregiving, caregiver burden, and well-being in the ICs of patients with HNC, compared with ICs receiving SAU only.

METHODS AND ANALYSIS

In this randomized controlled trial, 110 ICs of patients with HNC, undergoing radiotherapy combined with surgery and/or medical oncological treatment, will be randomized (1:1) to Carer eSupport plus SAU or SAU only. Data will be collected at baseline (before randomization), post-intervention (after 18 weeks), and 3 months after post-intervention. The primary outcome is self-reported preparedness for caregiving. Secondary outcomes are self-reported caregiver burden, anxiety, depression, and health-related quality of life. The effect of Carer eSupport plus SAU on preparedness for caregiving and secondary outcomes, compared with SAU only, will be evaluated by intention to treat analyses using linear regression models, mixed-model regression, or analysis of covariance.

DISCUSSION

If proven effective, Carer eSupport has the potential to significantly improve ICs' preparedness for caregiving and their wellbeing, thereby improving patient-perceived quality of care and patient wellbeing.

TRIAL REGISTRATION

ClinicalTrials.gov; NCT06307418, registered 12.03.2024 (https://clinicaltrials.gov/search? term=NCT06307418).

Address: Department of Immunology, Genetics, and Pathology, Uppsala University, Rudbecklaboratoriet, 75185, Uppsala, Sweden. [email protected].; Division of Visual Information and Interaction, Department of Information Technology, Uppsala University, 751 05, Uppsala, Box 337, Sweden.; Department of Surgery, Faculty of Medicine and Health, Örebro University, 701 82, Örebro, Sweden.; University Health Care Research Center, Faculty of Medicine and Health, Örebro University, 701 82, Örebro, Sweden.; Department of Nursing, Umeå University, 901 87, Umeå, Sweden.; Department of Diagnostics and Intervention, Umeå University, 901 87, Umeå, Sweden.; Healthcare Sciences and e-Health, Department of Women's and Children's Health, Uppsala University, Dag Hammarskjölds väg 14B, 751 85, Uppsala, Sweden.; Department of Immunology, Genetics, and Pathology, Uppsala University, Rudbecklaboratoriet, 75185, Uppsala, Sweden.; Department of Oncology, Sahlgrenska University Hospital, 413 45, Gothenburg, Sweden.; Department of Public Health and Caring Sciences, Uppsala University, 751 22, Uppsala, Box 564, Sweden.; Physiotherapy and behavioral medicine, Department of Women's and Children's Health, Uppsala University, 751 22, Uppsala, Box 564, Sweden.; The School of Health, Care and Social Welfare, Mälardalen University, 721 23, Västerås, Box 883, Sweden.; Department of Surgical Sciences, Section of Otorhinolaryngology and Head & Neck Surgery, Uppsala University, Akademiska sjukhuset, ingång 70, bv, Rudbecklaboratoriet, 75185, Uppsala, Sweden.

DOI: 10.1186/s12885-024-12273-y

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MeSH Terms: Humans, Caregivers, Quality of Life, Head and Neck Neoplasms, Caregiver Burden, Internet, Randomized Controlled Trials as Topic