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

May 22, 2025 updated by: Birgitta Johansson, Uppsala University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Blekinge Län
      • Örebro, Blekinge Län, Sweden, 70185
    • Uppsala Län
      • Uppsala, Uppsala Län, Sweden, 75105
        • Recruiting
        • Uppsala University Hospital
        • Principal Investigator:
          • Birgitta Johansson, Ass prof
        • Contact:
    • Västerbottens Län
      • Umeå, Västerbottens Län, Sweden, 90737
    • Västra Götaland
      • Göteborg, Västra Götaland, Sweden, 41345

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Internet-based support (Carer eSupport)
The internet-based support is developed in collaboration with clinical expertise within head and neck cancer care and an expert group of informal caregivers to patients with head and neck cancer. The support comprise text, lectures, films, discussion forum and real-time video meetings with clinical experts. The support will last for 18 weeks.
Other: Carer eSupport
Internet-based support
No Intervention: Support as usual
Support as usual comprise a possibility for informal caregivers to contact a specified nurse with expertise in head and neck , at the head and neck or oncology clinic, to ask for support. Healthcare counsellors at the clinics is also available for ICs on request. Group support providing emotional and social support for ICs to patients with various cancer diagnoses may also be arranged at the clinics occasionally. Also, the Swedish healthcare is always responsible for recognizing the need for support for children (< 18 years) of patients with cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The self-reported questionnaire Preparedness for caregiving scale
Time Frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
A self-reported questionnaire consisting of eight items, responded to on a 5-grade scale (0 not at all prepared - 4 very well prepared) concerning informal caregivers' (ICs) self-reported preparedness to take care of the patient's needs, find out about and set up services, get support from the health care system and manage the stress related to being an informal caregiver. The scores are summed to a scale ranging from 0-32, with a higher score reflecting better preparedness.
Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The self-reported questionnaire Caregiver Burden Scale
Time Frame: Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.
A self-reported questionnaire consisting of 22 items responded to on a 4-grade scale (1 Not at all - 4 Often), a higher score indicates a more significant burden. The 22 items may be divided into the factors of General strain, Disappointment, Emotional involvement, Environment, and Isolation, and the mean of all items indicates the total burden.
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.
A self-reported questionnaire consisting of 21 items constituting three subscales, with seven item each, measuring depression, anxiety, and stress. Each item is scored on a 4-grade scale, with higher scores indicating more symptoms.
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.
A self-reported health-related quality of life questionnaire consisting of 36 items measuring physical functioning (10 items), role limitations due to physical (4 items) and emotional (3 items) health problems, social functioning (2 items), emotional well-being (5 items), energy/fatigue (4 items), pain (2 items), and general health perceptions (5 items) and perceived change in health (1 item). All scales are scored so that that the lowest and highest possible scores are set at 0 and 100, respectively. Higher scores indicate a better health-related quality of life.
Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

The Swedish Research Council
Umeå University
University Hospital, Umeå
Region Örebro County
Uppsala University Hospital
Swedish Cancer Society
Sahlgrenska University Hospital

Investigators

  • Principal Investigator: Ylva Tiblom Ehrsson, Assoc prof, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carer eSupport RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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