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Recruiting NCT06307418

Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport

No phase Interventional Head and Neck Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carer eSupport.
Who it may be relevant to
Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Other Carer eSupport
    Internet-based support

Primary outcome measures

  • The self-reported questionnaire Preparedness for caregiving scale [Time frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.]
Secondary outcome measures (3)
  • The self-reported questionnaire Caregiver Burden Scale [Time frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.]
  • The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21) [Time frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.]
  • The self-reported health-related quality of life questionnaire RAND-36 [Time frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Sweden · 4 centers
  • Örebro University Hospital — Örebro
  • Uppsala university hospital — Uppsala
  • Norrland University Hospital — Umeå
  • Sahlgrenska university hospital — Gothenburg

Publications

  • Johansson B, Cajander A, Ahmad A, Ohlsson-Nevo E, Fransson P, Granstrom B, von Essen L, Langegard U, Pettersson M, Henriksson A, Ehrsson YT. The effect of internet-administered support (carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer compared with support as usual: a study protocol for a randomized controlled trial. BMC Cancer. 2024 Apr 1 PMID 38637744

Identifiers

NCT: NCT06307418 · Carer eSupport RCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗