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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Caregivers; Feasibility Study
• Intervention / Treatment: Other: Internet based support

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Birgitta Johansson, Docent; Phone Number: +46704250912; Email: birgitta.johansson@igp.uu.se
• Study Contact Backup: Name: Ulrica Langegård, PhD; Phone Number: +46729999020; Email: ulrica.langegard@igp.uu.se

Study Locations

• Sweden
  • Blekinge Län
    • Örebro, Blekinge Län, Sweden, 70185
      • Orebro University Hospital
  • Uppsala Län
    • Uppsala, Uppsala Län, Sweden, 75105
      • Uppsala University Hospital
  • Västerbottens Län
    • Umeå, Västerbottens Län, Sweden, 90737
      • Norrland University Hospital
  • Västra Götaland
    • Göteborg, Västra Götaland, Sweden, 41345
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: The Swedish Research Council; Region Örebro County; Region Västerbotten; Uppsala University Hospital; Swedish Cancer Society
• Investigators: Principal Investigator: Birgitta Johansson, Docent, Uppsala University, Department of Immunology, Genetics and pathology

Publications and helpful links

General Publications

• Langegard U, Cajander A, Carlsson M, von Essen L, Ahmad A, Laurell G, Tiblom Ehrsson Y, Johansson B. Internet-based support for informal caregivers to individuals with head and neck cancer (Carer eSupport): a study protocol for the development and feasibility testing of a complex online intervention. BMJ Open. 2022 May 27;12(5):e057442. doi: 10.1136/bmjopen-2021-057442.

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: August 24, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Carer eSupport

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers, since this is a feasibility study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No