Internet-based support for informal caregivers to individuals with head and neck cancer (Carer eSupport): a study protocol for the development and feasibility testing of a complex online intervention

Abstract

IntroductionIt is strongly recommended that randomised controlled trials are preceded with an exploration of the needs of the target population and feasibility testing of the intervention. The present study protocol is set out to describe these steps in the development of a complex intervention.The past decades’ transition of care from inpatient to outpatient settings has increased the complexity of caregivers’ responsibilities, which they may not be prepared for. There is a need to support informal caregivers (ICs) to prepare them for caregiving and decrease the caregiver burden. The main aim of this study is to describe the development of an internet-based intervention (Carer eSupport) to improve ICs’ ability to support individuals with head and neck cancer and to describe the testing of the feasibility and acceptability of Carer eSupport.Methods and analysisThis is a multicentre study involving the ear, nose and throat clinics and the oncology and radiotherapy clinics at three university hospitals. The study protocol comprises two phases, development and feasibility testing, using the Medical Research Council framework for developing a complex intervention. Carer eSupport will be based on the results from focus group discussions with ICs and healthcare professionals (planned for n=6–8 in respective groups) and scientific evidence, the Social Cognitive Theory and the Theory of Acceptance and Use of Technology. The feasibility testing will include 30 ICs who will have access to Carer eSupport for 1 month. The feasibility testing will be evaluated with a mixed-method design.Ethics and disseminationAll procedures have been approved by the Ethics Committee at Uppsala University (Dnr: 2020-04650). Informed consent will be obtained before enrolment of patients, their ICs and healthcare staff. The feasibility testing is registered at Clinicaltrials.gov (Identifier: NCT05028452). Findings will be disseminated in peer-reviewed journal publications.Trial registration numberClinicaltrials.gov (Identifier: NCT05028452

Design suggestions for a persuasive e-coaching application: A study on informal caregivers’ needs

“…Research shows that many informal caregivers need much more hours of assistance from formal caregivers but the formal care system is not equipped to handle this due to decreased investments in healthcare. 45 …”

“…Some interviewed caregivers struggled with accepting their children's disability at birth and felt that it was unfair that their children may live out “lesser lives.” Past research also acknowledges that most caregivers may find it difficult to deal with the uncertainty and being a sudden caregiver. 45 , 60 Some felt an ambiguous loss that their relative is not mentally there anymore (in dementia and Alzheimer's caregivers), which negatively affected their well-being. 61 Negative caregiver well-being may lead to frequent hospitalizations increasing the cost to formal healthcare.…”

Positive Design Framework for Carer eSupport: Qualitative Study to Support Informal Caregivers of Patients With Head and Neck Cancer in Sweden

“…This study adopted a qualitative research approach. Our ongoing project Carer eSupport [ 10 ] was used as a case to address the contextual nature of caregivers’ well-being. In this study, we conducted focus group discussions with different stakeholders.…”

“…Finally, the effectiveness, usability, relevance, and acceptability of Carer eSupport will be tested in a randomized controlled trial. Further details about the project can be accessed from our study protocol “Internet-based support for informal caregivers of individuals with head and neck cancer (Carer eSupport): a study protocol for the development and feasibility testing of a complex online intervention” [ 10 ].…”

Unmet supportive care needs among informal caregivers of patients with head and neck cancer in the first 2 years after diagnosis and treatment: a prospective cohort study

“…All the studies they included stated that having an opportunity to have contact with patients or informal caregivers that were experiencing a similarly trajectory was beneficial and reassuring [20]. In this regard, two recent study protocols for randomized controlled trials on the use of an eHealth system for partners of patients with HNC are promising [44,45]. However, further studies will be needed to test whether the proposed supportive care interventions are feasible.…”