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Clinical Trials/NCT05028452
NCT05028452
Completed
Not Applicable

Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer

Uppsala University4 sites in 1 country32 target enrollmentApril 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregivers
Sponsor
Uppsala University
Enrollment
32
Locations
4
Primary Endpoint
Inclusion rate
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Inclusion rate

Time Frame: 4 months

The proportion of caregivers who give informed consent for participation

Utilization of Carer eSupport

Time Frame: 2 months

The proportion of included caregivers who take use of Carer eSupport

Attrition

Time Frame: 3 months

The proportion of included caregivers who withdraw from the study

Perceived acceptability

Time Frame: Within 1 months after completion of testing Carer eSupport.

Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.

Completion of questionnaires

Time Frame: 3 months

The proportion of included caregivers who complete questionnaires

Perceived feasibility

Time Frame: Within 1 months after completion of testing Carer eSupport.

Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.

Secondary Outcomes

  • The Depression Anxiety Stress Scale-21(Assessed at baseline and at 1 months after access to Carer eSupport.)
  • Caregiver´s burden scale(Assessed at baseline and at 1 months after access to Carer eSupport.)
  • Short Form Health Survey (SF-36), v2.(Assessed at baseline and at 1 months after access to Carer eSupport.)
  • The Preparedness for caregiving scale(Assessed at baseline and at 1 months after access to Carer eSupport)
  • The Multidimensional fatigue inventory(Assessed at baseline and at 1 months after access to Carer eSupport.)

Study Sites (4)

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