Clinical trial NCT05028452: Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer
Official title: Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Head and Neck Cancer
Feasibility Study
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Cancer Society
name: Uppsala University Hospital
name: Region Västerbotten
name: Region Örebro County
First posted: 2021-08-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group posttest only design
Primary purpose: SUPPORTIVE_CARE

Brief summary: Informal caregivers to patients with head and neck cancer report that they are unprepared for caregiving, that they experience a high caregiver burden and a deteriorated health. The aim is to develop an internet based intervention for informal caregivers of individuals with head and neck cancer and evaluate the feasibility and acceptability of the intervention. The internet based intervention (Carer eSupport) will be based on scientific evidence, established theoretical frameworks and focus groups with caregivers and health care professionals. The feasibility and acceptability of Carer eSupport will be evaluated by 30 caregivers who will have access to Carer eSupport during one months. The feasibility and acceptability of Carer eSupport will be evaluated with quantitative and qualitative data.


Eligibility criteria: Inclusion Criteria:

* Informal caregivers (defined by the patients) to patients with head and neck cancer who are about to start treatment, undergoing treatment or have completed treatment within the past month.

Exclusion Criteria:

* Confusion or dementia, inability to understand, speak or read Swedish.

Primary outcomes:
measure: Inclusion rate
timeFrame: 4 months
measure: Utilization of Carer eSupport
timeFrame: 2 months
measure: Attrition
timeFrame: 3 months
measure: Completion of questionnaires
timeFrame: 3 months
measure: Perceived feasibility
timeFrame: Within 1 months after completion of testing Carer eSupport.
measure: Perceived acceptability
timeFrame: Within 1 months after completion of testing Carer eSupport.
Secondary outcomes:
measure: The Preparedness for caregiving scale
timeFrame: Assessed at baseline and at 1 months after access to Carer eSupport
measure: Caregiver´s burden scale
timeFrame: Assessed at baseline and at 1 months after access to Carer eSupport.
measure: Short Form Health Survey (SF-36), v2.
timeFrame: Assessed at baseline and at 1 months after access to Carer eSupport.
measure: The Depression Anxiety Stress Scale-21
timeFrame: Assessed at baseline and at 1 months after access to Carer eSupport.
measure: The Multidimensional fatigue inventory
timeFrame: Assessed at baseline and at 1 months after access to Carer eSupport.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
state: Blekinge Län
city: Uppsala
country: Sweden
facility: Uppsala university hospital
state: Uppsala Län
city: Umeå
country: Sweden
facility: Norrland University Hospital
state: Västerbottens Län
city: Göteborg
country: Sweden
facility: Sahlgrenska university hospital
state: Västra Götaland
Study officials:
affiliation: Uppsala University, Department of Immunology, Genetics and pathology
name: Birgitta Johansson, Docent
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langegard U, Cajander A, Carlsson M, von Essen L, Ahmad A, Laurell G, Tiblom Ehrsson Y, Johansson B. 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. BMJ Open. 2022 May 27;12(5):e057442. doi: 10.1136/bmjopen-2021-057442.