Carer eSupport
OtherInternet-based support
NCT Number: NCT06307418
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Örebro University Hospital, Örebro, Blekinge Län, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Internet-based support
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Birgitta Johansson, Assoc prof
CONTACT
Ylva Tiblom Ehrsson, Assoc prof
CONTACT
Uppsala University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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