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

NCT ID: NCT06307418

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Informal caregivers of patients with Head and neck cancer will be randomized to internet-based support or to support as usual.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Carer eSupport

Intervention Type OTHER

Internet-based support

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Carer eSupport

Internet-based support

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Cancer Society

OTHER

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Umeå

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Birgitta Johansson

Senior lecturer, Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ylva Tiblom Ehrsson, Assoc prof

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Örebro University Hospital

Örebro, Blekinge Län, Sweden

Site Status RECRUITING

Uppsala university hospital

Uppsala, Uppsala County, Sweden

Site Status RECRUITING

Norrland University Hospital

Umeå, Västerbotten County, Sweden

Site Status RECRUITING

Sahlgrenska university hospital

Gothenburg, Västra Götaland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Ylva Tiblom Ehrsson, Assoc prof

Role: CONTACT

+46707747712

Birgitta Johansson, Assoc prof

Role: CONTACT

Facility Contacts

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Emma Ohlsson-Nevo, Ass prof

Role: primary

+4619303000

Ylva Tiblom Ehrsson, Ass prof

Role: primary

+46706072905

Per Fransson, Professor

Role: primary

Ulrica Langegård, PhD

Role: primary

References

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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 18;24(1):494. doi: 10.1186/s12885-024-12273-y.

Reference Type DERIVED
PMID: 38637744 (View on PubMed)

Other Identifiers

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Carer eSupport RCT

Identifier Type: -

Identifier Source: org_study_id

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