Head and Neck Cancer
Conditions
Keywords
Informal caregivers, Internet-based support, Preparedness for caregiving, Caregiver burden, Quality of life
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.
Interventions
OTHERCarer eSupport
Internet-based support
Sponsors
Uppsala University
The Swedish Research Council
Swedish Cancer Society
Umeå University
Region Örebro County
Sahlgrenska University Hospital
University Hospital, Umeå
Uppsala University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Informal caregivers of patients with Head and neck cancer will be randomized to internet-based support or to support as usual.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORYlva Tiblom Ehrsson, Assoc prof
Uppsala University
Outcome results
None listed