CClinicalTrials.gg
CompletedNCT05028452Updated Feb 16, 2024

Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer

An interventional study of Internet based support in Caregivers, Head and Neck Cancer and Feasibility Study, sponsored by Uppsala University. Completed at 4 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Uppsala University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Caregivers
  • Head and Neck Cancer
  • Feasibility Study
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.

This study's enrollment of 32 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Confusion or dementia, inability to understand, speak or read Swedish.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Other
    Internet based support

    Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.

    Other: Internet based support

Interventions

  • OtherInternet based support

    Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.

    Also known as: Carer eSupport

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What researchers measure

Primary outcomes

  1. Inclusion rate

    The proportion of caregivers who give informed consent for participation

    Time frame: 4 months

  2. Utilization of Carer eSupport

    The proportion of included caregivers who take use of Carer eSupport

    Time frame: 2 months

  3. Attrition

    The proportion of included caregivers who withdraw from the study

    Time frame: 3 months

  4. Completion of questionnaires

    The proportion of included caregivers who complete questionnaires

    Time frame: 3 months

  5. Perceived feasibility

    Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.

    Time frame: Within 1 months after completion of testing Carer eSupport.

  6. Perceived acceptability

    Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.

    Time frame: Within 1 months after completion of testing Carer eSupport.

Secondary outcomes

  1. 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.

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport

  2. Caregiver´s burden scale

    A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial.

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

  3. 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.

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

  4. 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.

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

  5. 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.

    Time frame: Assessed at baseline and at 1 months after access to Carer eSupport.

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Study locations

4 sites
  • Örebro University Hospital
    Örebro, Blekinge Län 70185, Sweden
  • Uppsala university hospital
    Uppsala, Uppsala Län 75105, Sweden
  • Norrland University Hospital
    Umeå, Västerbottens Län 90737, Sweden
  • Sahlgrenska university hospital
    Göteborg, Västra Götaland 41345, Sweden
08

References and documents

Publications

  • Langegard 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 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers, since this is a feasibility study.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05028452
Lead sponsor
Uppsala University
Collaborators
The Swedish Research Council, Swedish Cancer Society, Uppsala University Hospital, Region Västerbotten, Region Örebro County
Responsible party
Sponsor
First posted
Aug 31, 2021
Start date
Apr 17, 2023
Primary completion
Sep 30, 2023
Completion
Sep 30, 2023
Last update
Feb 16, 2024

Study contacts

Birgitta Johansson, Docent
principal investigator · Uppsala University, Department of Immunology, Genetics and pathology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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