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

• Sponsor: Uppsala University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05028452
• Collaborator: The Swedish Research Council (Other), Swedish Cancer Society (Other), Uppsala University Hospital (Other), Region Västerbotten (Other), Region Örebro County (Other)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caregivers; Head and Neck Cancer; Feasibility Study	Other: Internet based support	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single group posttest only designSingle group posttest only design
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Internet based support Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.	Other: Internet based support; Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.; Other Names: Carer eSupport

Outcome Measures

Primary Outcome Measures

1. Inclusion rate [4 months]

   The proportion of caregivers who give informed consent for participation

2. Utilization of Carer eSupport [2 months]

   The proportion of included caregivers who take use of Carer eSupport

3. Attrition [3 months]

   The proportion of included caregivers who withdraw from the study

4. Completion of questionnaires [3 months]

   The proportion of included caregivers who complete questionnaires

5. Perceived feasibility [Within 1 months after completion of testing Carer eSupport.]

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

6. Perceived acceptability [Within 1 months after completion of testing Carer eSupport.]

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

Secondary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Uppsala University
• The Swedish Research Council
• Swedish Cancer Society
• Uppsala University Hospital
• Region Västerbotten
• Region Örebro County

Investigators

• Principal Investigator: Birgitta Johansson, Docent, Uppsala University, Department of Immunology, Genetics and pathology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT05028452
• Other Study ID Numbers: Carer eSupport
• First Posted: Aug 31, 2021
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Head and Neck Neoplasms

Study Results

No Results Posted as of Aug 31, 2021