Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
September 10, 2026 updated by: Birgitta Johansson, Uppsala University
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
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Blekinge Län
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Örebro, Blekinge Län, Sweden, 70185
- Örebro University Hospital
-
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Uppsala County
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Uppsala, Uppsala County, Sweden, 75105
- Uppsala university hospital
-
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Västerbotten County
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Umeå, Västerbotten County, Sweden, 90737
- Norrland University Hospital
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Västra Götaland County
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Gothenburg, Västra Götaland County, Sweden, 41345
- Sahlgrenska University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Internet-based support (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.
|
Internet-based support
|
|
No Intervention: Support as usual
Support as usual comprise a possibility for informal caregivers to contact a specified nurse with expertise in head and neck , at the head and neck or oncology clinic, to ask for support.
Healthcare counsellors at the clinics is also available for ICs on request.
Group support providing emotional and social support for ICs to patients with various cancer diagnoses may also be arranged at the clinics occasionally.
Also, the Swedish healthcare is always responsible for recognizing the need for support for children (< 18 years) of patients with cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The self-reported questionnaire Caregiver Burden Scale
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.
|
Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
|
|
The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21)
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.
|
Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
|
|
The self-reported health-related quality of life questionnaire RAND-36
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.
|
Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ylva Tiblom Ehrsson, Assoc prof, Uppsala University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2024
Primary Completion (Estimated)
October 24, 2026
Study Completion (Estimated)
October 24, 2026
Study Registration Dates
First Submitted
February 27, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
September 11, 2026
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Carer eSupport RCT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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