Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Caregivers, Head and Neck Cancer, Feasibility Study

Intervention / Treatment
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* Other: Internet based support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Single group posttest only design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Internet based support<br>Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer. | Other: Internet based support<br>* Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.<br>* Other names: Carer eSupport;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inclusion rate | The proportion of caregivers who give informed consent for participation | 4 months | 
| Utilization of Carer eSupport | The proportion of included caregivers who take use of Carer eSupport | 2 months | 
| Attrition | The proportion of included caregivers who withdraw from the study | 3 months | 
| Completion of questionnaires | The proportion of included caregivers who complete questionnaires | 3 months | 
| Perceived feasibility | Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport. | Within 1 months after completion of testing Carer eSupport. | 
| Perceived acceptability | Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport. | Within 1 months after completion of testing Carer eSupport. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Preparedness for caregiving scale | A brief 8-item self-report measure assessing preparedness for caregiving, a potential primary outcome in a future randomized controlled trial. | Assessed at baseline and at 1 months after access to Carer eSupport | 
| Caregiver´s burden scale | A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial. | Assessed at baseline and at 1 months after access to Carer eSupport. | 
| Short Form Health Survey (SF-36), v2. | A 36-item self-report measure assessing self-perceived health, a potential secondary outcome in a future randomized controlled trial. | Assessed at baseline and at 1 months after access to Carer eSupport. | 
| The Depression Anxiety Stress Scale-21 | A 21-item self-report measure assessing depression, anxiety, and stress, a potential secondary outcome in a future randomized controlled trial. | Assessed at baseline and at 1 months after access to Carer eSupport. | 
| The Multidimensional fatigue inventory | A 20-item self-report measure assessing five dimensions of fatigue, a potential secondary outcome in a future randomized controlled trial. | Assessed at baseline and at 1 months after access to Carer eSupport. |