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

Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05028452
Enrollment
32
Registered
2021-08-31
Start date
2023-04-17
Completion date
2023-09-30
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caregivers, Feasibility Study, Head and Neck Cancer

Brief 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.

Interventions

OTHERInternet based support

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

Sponsors

The Swedish Research Council
CollaboratorOTHER_GOV
Swedish Cancer Society
CollaboratorOTHER
Uppsala University Hospital
CollaboratorOTHER
Region Västerbotten
CollaboratorOTHER_GOV
Region Örebro County
CollaboratorOTHER
Uppsala University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Single group posttest only design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* Confusion or dementia, inability to understand, speak or read Swedish.

Design outcomes

Primary

MeasureTime frameDescription
Perceived acceptabilityWithin 1 months after completion of testing Carer eSupport.Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.
Inclusion rate4 monthsThe proportion of caregivers who give informed consent for participation
Utilization of Carer eSupport2 monthsThe proportion of included caregivers who take use of Carer eSupport
Attrition3 monthsThe proportion of included caregivers who withdraw from the study
Completion of questionnaires3 monthsThe proportion of included caregivers who complete questionnaires
Perceived feasibilityWithin 1 months after completion of testing Carer eSupport.Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.

Secondary

MeasureTime frameDescription
Caregiver´s burden scaleAssessed at baseline and at 1 months after access to Carer eSupport.A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial.
Short Form Health Survey (SF-36), v2.Assessed at baseline and at 1 months after access to Carer eSupport.A 36-item self-report measure assessing self-perceived health, a potential secondary outcome in a future randomized controlled trial.
The Depression Anxiety Stress Scale-21Assessed at baseline and at 1 months after access to Carer eSupport.A 21-item self-report measure assessing depression, anxiety, and stress, a potential secondary outcome in a future randomized controlled trial.
The Multidimensional fatigue inventoryAssessed at baseline and at 1 months after access to Carer eSupport.A 20-item self-report measure assessing five dimensions of fatigue, a potential secondary outcome in a future randomized controlled trial.
The Preparedness for caregiving scaleAssessed at baseline and at 1 months after access to Carer eSupportA brief 8-item self-report measure assessing preparedness for caregiving, a potential primary outcome in a future randomized controlled trial.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026