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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2023

Interventions

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

Arms, Groups and Cohorts

  • Other: Internet based support
    • Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • The Preparedness for caregiving scale
    • Time Frame: 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.
  • Caregiver´s burden scale
    • Time Frame: 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.
    • Time Frame: 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 Depression Anxiety Stress Scale-21
    • Time Frame: 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.
  • The Multidimensional fatigue inventory
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Uppsala University
  • Collaborator
    • The Swedish Research Council
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Birgitta Johansson, Docent, Principal Investigator, Uppsala University, Department of Immunology, Genetics and pathology

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