Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
- Conditions
- Head and Neck Cancer
- Interventions
- Other: Carer eSupport
- Registration Number
- NCT06307418
- Lead Sponsor
- Uppsala University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Internet-based support (Carer eSupport) Carer eSupport The internet-based support is developed in collaboration with clinical expertise within head and neck cancer care and an expert group of informal caregivers to patients with head and neck cancer. The support comprise text, lectures, films, discussion forum and real-time video meetings with clinical experts. The support will last for 18 weeks.
- Primary Outcome Measures
Name Time Method The self-reported questionnaire Preparedness for caregiving scale 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 Outcome Measures
Name Time Method The self-reported questionnaire Caregiver Burden Scale Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention. A self-reported questionnaire consisting of 22 items responded to on a 4-grade scale (1 Not at all - 4 Often), a higher score indicates a more significant burden. The 22 items may be divided into the factors of General strain, Disappointment, Emotional involvement, Environment, and Isolation, and the mean of all items indicates the total burden.
The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21) Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention. A self-reported questionnaire consisting of 21 items constituting three subscales, with seven item each, measuring depression, anxiety, and stress. Each item is scored on a 4-grade scale, with higher scores indicating more symptoms.
The self-reported health-related quality of life questionnaire RAND-36 Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention. A self-reported health-related quality of life questionnaire consisting of 36 items measuring physical functioning (10 items), role limitations due to physical (4 items) and emotional (3 items) health problems, social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) and perceived change in health (1 item). All scales are scored so that that the lowest and highest possible scores are set at 0 and 100, respectively. Higher scores indicate a better health-related quality of life.
Trial Locations
- Locations (4)
Örebro University Hospital
🇸🇪Örebro, Blekinge Län, Sweden
Uppsala university hospital
🇸🇪Uppsala, Uppsala Län, Sweden
Sahlgrenska university hospital
🇸🇪Göteborg, Västra Götaland, Sweden
Norrland University Hospital
🇸🇪Umeå, Västerbottens Län, Sweden