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NCT Number: NCT06307418

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University Hospital, Örebro, Blekinge Län, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carer eSupport

Other

Internet-based support

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Birgitta Johansson, Assoc prof

CONTACT

[email protected]

Ylva Tiblom Ehrsson, Assoc prof

CONTACT

[email protected]

+46707747712

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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