The Effects of Internet-based Support (Carer eSupport) on Preparedness for Caregiving in Informal Caregivers of Patients With Head and Neck Cancer Compared to Standard Care Support - a Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Uppsala University
- Enrollment
- 110
- Locations
- 4
- Primary Endpoint
- The self-reported questionnaire Preparedness for caregiving scale
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question[s] it aims to answer are:
- What are the effects of internet-based support on informal caregivers preparedness for caregiving?
- What are the effects of internet-based support on informal caregivers burden and wellbeing?
Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at:
- baseline (before randomization)
- 18 weeks (post-intervention) and at
- 3 months after the intervention is completed (long term follow-up).
Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing.
Investigators
Birgitta Johansson
Senior lecturer, Associate professor
Uppsala University
Eligibility Criteria
Inclusion Criteria
- •Informal caregivers who have been identified as an informal caregiver by a patient who have consented to that the informal caregivers is approached.
- •Informal caregivers of patients with head and neck cancer who are about to start radiotherapy or have undergone at most five radiotherapy treatment session. Radiotherapy may be combined with surgery and/or medical oncological treatment.
Exclusion Criteria
- •Informal caregivers who do not understand and read Swedish or suffer from cognitive impairment, and informal caregivers with who need support or treatment that cannot be provided by Carer eSupport.
Outcomes
Primary Outcomes
The self-reported questionnaire Preparedness for caregiving scale
Time Frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
A self-reported questionnaire consisting of eight items, responded to on a 5-grade scale (0 not at all prepared - 4 very well prepared) concerning informal caregivers' (ICs) self-reported preparedness to take care of the patient's needs, find out about and set up services, get support from the health care system and manage the stress related to being an informal caregiver. The scores are summed to a scale ranging from 0-32, with a higher score reflecting better preparedness.
Secondary Outcomes
- The self-reported questionnaire Caregiver Burden Scale(Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.)
- The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21)(Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.)
- The self-reported health-related quality of life questionnaire RAND-36(Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.)