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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028452
• Other study ID #: Carer eSupport
• Status: Completed
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregivers
• Feasibility Study
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Internet based support
Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Göteborg	Västra Götaland
Sweden	Örebro University Hospital	Örebro	Blekinge Län
Sweden	Norrland University Hospital	Umeå	Västerbottens Län
Sweden	Uppsala university hospital	Uppsala	Uppsala Län

Sponsors (6)

Lead Sponsor	Collaborator
Uppsala University	Region Örebro County, Region Västerbotten, Swedish Cancer Society, The Swedish Research Council, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

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