CaregiversNCT05028452
Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer
A study testing Internet based support in people with Caregivers and Head and Neck Cancer, run by Uppsala University at 4 sites in Sweden.
Trial summary
Informal caregivers to patients with head and neck cancer report that they are unprepared for caregiving, that they experience a high caregiver burden and a deteriorated health. The aim is to develop an internet based intervention for informal caregivers of individuals with head and neck cancer and evaluate the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers, Head and Neck Cancer, Feasibility Study
- What is being tested?
- Internet based support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesSweden
- Study dates
- 17 Apr 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (defined by the patients) to patients with head and neck cancer who are about to start treatment, undergoing treatment or have completed treatment within the past month.
Who cannot join
- Confusion or dementia, inability to understand, speak or read Swedish.
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: Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer
Informal caregivers to patients with head and neck cancer report that they are unprepared for caregiving, that they experience a high caregiver burden and a deteriorated health. The aim is to develop an internet based intervention for informal caregivers of individuals with head and neck cancer and evaluate the feasibility and acceptability of the intervention. The internet based intervention (Carer eSupport) will be based on scientific evidence, established theoretical frameworks and focus groups with caregivers and health care professionals. The feasibility and acceptability of Carer eSupport will be evaluated by 30 caregivers who will have access to Carer eSupport during one months. The feasibility and acceptability of Carer eSupport will be evaluated with quantitative and qualitative data.
- Conditions
- Caregivers, Head and Neck Cancer, Feasibility Study
- Being tested
- Internet based support
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based supportOther
Also called Carer eSupport
Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.
| Study group | Role | What they receive |
|---|---|---|
| Internet based support | Other | Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer. Receives: Other: Internet based support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclusion rate
The proportion of caregivers who give informed consent for participation
Measured: 4 months
Utilization of Carer eSupport
The proportion of included caregivers who take use of Carer eSupport
Measured: 2 months
Attrition
The proportion of included caregivers who withdraw from the study
Measured: 3 months
Completion of questionnaires
The proportion of included caregivers who complete questionnaires
Measured: 3 months
Perceived feasibility
Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.
Measured: Within 1 months after completion of testing Carer eSupport.
Perceived acceptability
Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.
Measured: Within 1 months after completion of testing Carer eSupport.
Secondary outcomes (5)
The Preparedness for caregiving scale
A brief 8-item self-report measure assessing preparedness for caregiving, a potential primary outcome in a future randomized controlled trial.
Measured: Assessed at baseline and at 1 months after access to Carer eSupport
Caregiver´s burden scale
A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial.
Measured: Assessed at baseline and at 1 months after access to Carer eSupport.
Short Form Health Survey (SF-36), v2.
A 36-item self-report measure assessing self-perceived health, a potential secondary outcome in a future randomized controlled trial.
Measured: Assessed at baseline and at 1 months after access to Carer eSupport.
The Depression Anxiety Stress Scale-21
A 21-item self-report measure assessing depression, anxiety, and stress, a potential secondary outcome in a future randomized controlled trial.
Measured: Assessed at baseline and at 1 months after access to Carer eSupport.
The Multidimensional fatigue inventory
A 20-item self-report measure assessing five dimensions of fatigue, a potential secondary outcome in a future randomized controlled trial.
Measured: Assessed at baseline and at 1 months after access to Carer eSupport.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start17 Apr 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group posttest only design
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Cancer Society, Uppsala University Hospital, Region Västerbotten, Region Örebro County
- Responsible party
- Sponsor
- Investigators
- Birgitta Johansson, Docent, Principal investigator, Uppsala University, Department of Immunology, Genetics and pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028452
- Sponsor's protocol ID
- Carer eSupport
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2021
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers, since this is a feasibility study.
Publications
Ahmad A, Cajander A, Langegard U, Johansson B, Henriksson A, Pettersson M, Ahmad W, Tiblom Ehrsson Y. The Development of a Web-Based Application to Support Informal Caregivers of Individuals With Head and Neck Cancer: Human-Centered Design Approach. JMIR Hum Factors. 2026 Apr 8;13:e81896. doi: 10.2196/81896.
PubMed 41950374Langegard U, Cajander A, Carlsson M, von Essen L, Ahmad A, Laurell G, Tiblom Ehrsson Y, Johansson B. Internet-based support for informal caregivers to individuals with head and neck cancer (Carer eSupport): a study protocol for the development and feasibility testing of a complex online intervention. BMJ Open. 2022 May 27;12(5):e057442. doi: 10.1136/bmjopen-2021-057442.
PubMed 35623759
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05028452
- Acronym / sponsor ID
- Carer eSupport
- Conditions
- Caregivers, Head and Neck Cancer, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Cancer Society, Uppsala University Hospital, Region Västerbotten, Region Örebro County
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 31 Aug 2021 (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.
Informal caregivers to patients with head and neck cancer report that they are unprepared for caregiving, that they experience a high caregiver burden and a deteriorated health. The aim is to develop an internet based intervention for informal caregivers of individuals with head and neck cancer and evaluate the feasibility and acceptability of the intervention. The internet based intervention (Carer eSupport) will be based on scientific evidence, established theoretical frameworks and focus groups with caregivers and health care professionals. The feasibility and acceptability of Carer eSupport will be evaluated by 30 caregivers who will have access to Carer eSupport during one months. The feasibility and acceptability of Carer eSupport will be evaluated with quantitative and qualitative data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group posttest only design
| Arm | Type | Receives |
|---|---|---|
| Internet based support | Other | Other: Internet based supportInternet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informal caregivers (defined by the patients) to patients with head and neck cancer who are about to start treatment, undergoing treatment or have completed treatment within the past month.
Key exclusion criteria (1 listed)
- Confusion or dementia, inability to understand, speak or read Swedish.
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 |
|---|---|---|
| Internet based supportAlso: Carer eSupportCarer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health. | Other | Internet based support |
Primary outcome
Inclusion rate
Time frame: 4 months
The proportion of caregivers who give informed consent for participation
Utilization of Carer eSupport
Time frame: 2 months
The proportion of included caregivers who take use of Carer eSupport
Attrition
Time frame: 3 months
The proportion of included caregivers who withdraw from the study
Completion of questionnaires
Time frame: 3 months
The proportion of included caregivers who complete questionnaires
Perceived feasibility
Time frame: Within 1 months after completion of testing Carer eSupport.
Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.
Perceived acceptability
Time frame: Within 1 months after completion of testing Carer eSupport.
Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.
5 secondary outcomes
The Preparedness for caregiving scale
Time frame: Assessed at baseline and at 1 months after access to Carer eSupport
Caregiver´s burden scale
Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.
Short Form Health Survey (SF-36), v2.
Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.
The Depression Anxiety Stress Scale-21
Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.
The Multidimensional fatigue inventory
Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 41950374Ahmad A, Cajander A, Langegard U, Johansson B, Henriksson A, Pettersson M, Ahmad W, Tiblom Ehrsson Y. The Development of a Web-Based Application to Support Informal Caregivers of Individuals With Head and Neck Cancer: Human-Centered Design Approach. JMIR Hum Factors. 2026 Apr 8;13:e81896. doi: 10.2196/81896.
- Derived from this study: PubMed 35623759Langegard U, Cajander A, Carlsson M, von Essen L, Ahmad A, Laurell G, Tiblom Ehrsson Y, Johansson B. Internet-based support for informal caregivers to individuals with head and neck cancer (Carer eSupport): a study protocol for the development and feasibility testing of a complex online intervention. BMJ Open. 2022 May 27;12(5):e057442. doi: 10.1136/bmjopen-2021-057442.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers, since this is a feasibility study.
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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.
Birgitta Johansson, Docent principal investigator
Uppsala University, Department of Immunology, Genetics and pathology
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based support in people with Caregivers and 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 1 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: finished, as of the sponsor's last update on 16 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inclusion rate (time frame: 4 months). The study lists 6 primary outcomes in all. 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 NCT05028452, which also lists 2 linked publications.
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 16 Feb 2024.