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

Not Applicable

Completed

• Conditions: Caregivers; Feasibility Study; Head and Neck Cancer
• Interventions: Other: Internet based support

• Registration Number: NCT05028452
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-31
• Study Start: 2023-04-17
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet based support	Internet based support	Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Örebro University Hospital; 🇸🇪 Örebro, Blekinge Län, Sweden

Uppsala university hospital; 🇸🇪 Uppsala, Uppsala Län, Sweden

Sahlgrenska university hospital; 🇸🇪 Göteborg, Västra Götaland, Sweden

Norrland University Hospital; 🇸🇪 Umeå, Västerbottens Län, Sweden