Clinical trial NCT06307418: Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Informal caregivers
Internet-based support
Preparedness for caregiving
Caregiver burden
Quality of life
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Cancer Society
name: Umeå University
name: Region Örebro County
name: Sahlgrenska University Hospital
name: University Hospital, Umeå
name: Uppsala University Hospital
First posted: 2024-03-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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.


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.

Primary outcomes:
measure: The self-reported questionnaire Preparedness for caregiving scale
timeFrame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
Secondary outcomes:
measure: The self-reported questionnaire Caregiver Burden Scale
timeFrame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
measure: The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21)
timeFrame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
measure: The self-reported health-related quality of life questionnaire RAND-36
timeFrame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
state: Blekinge Län
city: Uppsala
country: Sweden
facility: Uppsala university hospital
state: Uppsala Län
city: Umeå
country: Sweden
facility: Norrland University Hospital
state: Västerbottens Län
city: Göteborg
country: Sweden
facility: Sahlgrenska university hospital
state: Västra Götaland
Study officials:
affiliation: Uppsala University
name: Ylva Tiblom Ehrsson, Assoc prof
role: PRINCIPAL_INVESTIGATOR
References: