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

NCT06307418 | Recruiting

• 1 other identifier: Carer eSupport RCT
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Cancer

Keywords

Informal caregivers; Internet-based support; Preparedness for caregiving; Caregiver burden; Quality of life

Outcome Measures

Primary Outcomes (1)

• The self-reported questionnaire Preparedness for caregiving scale

  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 Outcomes (3)

• The self-reported questionnaire Caregiver Burden Scale

  Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.

• The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21)

  Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.

• The self-reported health-related quality of life questionnaire RAND-36

  Baseline, 18 weeks after randomization (post-intervention) and 3 months after post-intervention.

Study Arms (2)

Internet-based support (Carer eSupport)

EXPERIMENTAL

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

Support as usual

NO INTERVENTION

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.

Interventions

Carer eSupport OTHER

Internet-based support

Internet-based support (Carer eSupport)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Örebro University Hospital

Örebro, Blekinge Län, 70185, Sweden

RECRUITING

Uppsala university hospital

Uppsala, Uppsala County, 75105, Sweden

RECRUITING

Norrland University Hospital

Umeå, Västerbotten County, 90737, Sweden

RECRUITING

Sahlgrenska university hospital

Gothenburg, Västra Götaland County, 41345, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 38637744 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Ylva Tiblom Ehrsson, Assoc prof

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ylva Tiblom Ehrsson, Assoc prof

CONTACT

+46707747712; ylva.tiblom.ehrsson@uu.se

Birgitta Johansson, Assoc prof

CONTACT

birgitta.johansson@igp.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer, Associate professor

Model Details: Informal caregivers of patients with Head and neck cancer will be randomized to internet-based support or to support as usual.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

SE (4)