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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06307418
• Other study ID #: Carer eSupport RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: March 2024
• Source: Uppsala University
• Contact: Birgitta Johansson, Assoc prof
• Phone: +46706072905
• Email: birgitta.johansson[@]igp.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Other:
• Carer eSupport
Internet-based support

Locations

Country	Name	City	State
Sweden	Sahlgrenska university hospital	Göteborg	Västra Götaland
Sweden	Örebro University Hospital	Örebro	Blekinge Län
Sweden	Norrland University Hospital	Umeå	Västerbottens Län
Sweden	Uppsala university hospital	Uppsala	Uppsala Län

Sponsors (8)

Lead Sponsor	Collaborator
Uppsala University	Region Örebro County, Sahlgrenska University Hospital, Sweden, Swedish Cancer Society, The Swedish Research Council, Umeå University, University Hospital, Umeå, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The self-reported questionnaire Caregiver Burden Scale	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.
Secondary	The self-reported questionnaire Depression Anxiety Stress Scale-21 (DASS21)	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.
Secondary	The self-reported health-related quality of life questionnaire RAND-36	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.