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Trial Title:
Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
NCT ID:
NCT06307418
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
Informal caregivers
Internet-based support
Preparedness for caregiving
Caregiver burden
Quality of life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Informal caregivers of patients with Head and neck cancer will be randomized to
internet-based support or to support as usual.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Carer eSupport
Description:
Internet-based support
Arm group label:
Internet-based support (Carer eSupport)
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. 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Örebro University Hospital
Address:
City:
Örebro
Zip:
70185
Country:
Sweden
Facility:
Name:
Uppsala university hospital
Address:
City:
Uppsala
Zip:
75105
Country:
Sweden
Facility:
Name:
Norrland University Hospital
Address:
City:
Umeå
Zip:
90737
Country:
Sweden
Facility:
Name:
Sahlgrenska university hospital
Address:
City:
Göteborg
Zip:
41345
Country:
Sweden
Start date:
May 6, 2024
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Uppsala University
Agency class:
Other
Collaborator:
Agency:
The Swedish Research Council
Agency class:
Other
Collaborator:
Agency:
Swedish Cancer Society
Agency class:
Other
Collaborator:
Agency:
Umeå University
Agency class:
Other
Collaborator:
Agency:
Region Örebro County
Agency class:
Other
Collaborator:
Agency:
Sahlgrenska University Hospital, Sweden
Agency class:
Other
Collaborator:
Agency:
University Hospital, Umeå
Agency class:
Other
Collaborator:
Agency:
Uppsala University Hospital
Agency class:
Other
Source:
Uppsala University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06307418
