Head and Neck CancerNCT06307418
Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
A study testing Carer eSupport in people with Head and Neck Cancer, run by Uppsala University at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Carer eSupport
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesSweden
- Study dates
- 12 Aug 2024to 24 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Sahlgrenska university hospital
Gothenburg, Västra Götaland County, 41345
Örebro University Hospital
Örebro, Blekinge Län, 70185
Norrland University Hospital
Umeå, Västerbotten County, 90737
Uppsala university hospital
Uppsala, Uppsala County, 75105
About this study
Official title: 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?
Read more
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Carer eSupport
- Keywords
- Informal caregivers, Internet-based support, Preparedness for caregiving, Caregiver burden, Quality of life
- Medical subject headings
- Head and Neck Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carer eSupportOther
Internet-based support
| Study group | Role | What they receive |
|---|---|---|
| Internet-based support (Carer eSupport) | Experimental | 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. Receives: Other: Carer eSupport |
| Support as usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The self-reported questionnaire Preparedness for caregiving scale
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.
Measured: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
Secondary outcomes (3)
The self-reported questionnaire Caregiver Burden Scale
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.
Measured: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21)
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.
Measured: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
The self-reported health-related quality of life questionnaire RAND-36
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.
Measured: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start12 Aug 2024
- Primary completion24 Oct 2026 (estimated)
- Study completion24 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Informal caregivers of patients with Head and neck cancer will be randomized to internet-based support or to support as usual.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Cancer Society, Umeå University, Region Örebro County, Sahlgrenska University Hospital, University Hospital, Umeå, Uppsala University Hospital
- Responsible party
- Principal investigator, Birgitta Johansson, Uppsala University
- Investigators
- Ylva Tiblom Ehrsson, Assoc prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307418
- Sponsor's protocol ID
- Carer eSupport RCT
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2024
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johansson B, Cajander A, Ahmad A, Ohlsson-Nevo E, Fransson P, Granstrom B, von Essen L, Langegard U, Pettersson M, Henriksson A, Ehrsson YT. The effect of internet-administered support (carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer compared with support as usual: a study protocol for a randomized controlled trial. BMC Cancer. 2024 Apr 18;24(1):494. doi: 10.1186/s12885-024-12273-y.
PubMed 38637744
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06307418
- Acronym / sponsor ID
- Carer eSupport RCT
- Conditions
- Head and Neck Cancer
- Keywords
- Informal caregivers, Internet-based support, Preparedness for caregiving, Caregiver burden, Quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Cancer Society, Umeå University, Region Örebro County, Sahlgrenska University Hospital, University Hospital, Umeå, Uppsala University Hospital
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 24 Oct 2026 (estimated)
- Study completion
- 24 Oct 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Informal caregivers of patients with Head and neck cancer will be randomized to internet-based support or to support as usual.
| Arm | Type | Receives |
|---|---|---|
| Internet-based support (Carer eSupport) | Experimental | Other: Carer eSupportThe 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. |
| Support as usual | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carer eSupportInternet-based support | Other | Internet-based support (Carer eSupport) |
Primary outcome
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.
3 secondary outcomes
The self-reported questionnaire Caregiver Burden Scale
Time frame: 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Derived from this study: PubMed 38637744Johansson B, Cajander A, Ahmad A, Ohlsson-Nevo E, Fransson P, Granstrom B, von Essen L, Langegard U, Pettersson M, Henriksson A, Ehrsson YT. The effect of internet-administered support (carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer compared with support as usual: a study protocol for a randomized controlled trial. BMC Cancer. 2024 Apr 18;24(1):494. doi: 10.1186/s12885-024-12273-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ylva Tiblom Ehrsson, Assoc prof principal investigator
Uppsala University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carer eSupport in people with Head and Neck Cancer, run by Uppsala University at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The self-reported questionnaire Preparedness for caregiving scale (time frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06307418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.