Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer

NCT05028452 | Completed

• 1 other identifier: Carer eSupport
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

Informal caregivers to patients with head and neck cancer report that they are unprepared for caregiving, that they experience a high caregiver burden and a deteriorated health. The aim is to develop an internet based intervention for informal caregivers of individuals with head and neck cancer and evaluate the feasibility and acceptability of the intervention. The internet based intervention (Carer eSupport) will be based on scientific evidence, established theoretical frameworks and focus groups with caregivers and health care professionals. The feasibility and acceptability of Carer eSupport will be evaluated by 30 caregivers who will have access to Carer eSupport during one months. The feasibility and acceptability of Carer eSupport will be evaluated with quantitative and qualitative data.

Conditions

Caregivers; Head and Neck Cancer; Feasibility Study

Outcome Measures

Primary Outcomes (6)

• Inclusion rate

  The proportion of caregivers who give informed consent for participation

  4 months

• Utilization of Carer eSupport

  The proportion of included caregivers who take use of Carer eSupport

  2 months

• Attrition

  The proportion of included caregivers who withdraw from the study

  3 months

• Completion of questionnaires

  The proportion of included caregivers who complete questionnaires

  3 months

• Perceived feasibility

  Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.

  Within 1 months after completion of testing Carer eSupport.

• Perceived acceptability

  Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.

  Within 1 months after completion of testing Carer eSupport.

Secondary Outcomes (5)

• The Preparedness for caregiving scale

  Assessed at baseline and at 1 months after access to Carer eSupport

• Caregiver´s burden scale

  Assessed at baseline and at 1 months after access to Carer eSupport.

• Short Form Health Survey (SF-36), v2.

  Assessed at baseline and at 1 months after access to Carer eSupport.

• The Depression Anxiety Stress Scale-21

  Assessed at baseline and at 1 months after access to Carer eSupport.

• The Multidimensional fatigue inventory

  Assessed at baseline and at 1 months after access to Carer eSupport.

Study Arms (1)

Internet based support

OTHER

Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.

Other: Internet based support

Interventions

Internet based support OTHER

Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.

Also known as: Carer eSupport

Internet based support

Eligibility Criteria

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

You may qualify if:

• Informal caregivers (defined by the patients) to patients with head and neck cancer who are about to start treatment, undergoing treatment or have completed treatment within the past month.

You may not qualify if:

• Confusion or dementia, inability to understand, speak or read Swedish.

Sponsors & Collaborators

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

Study Sites (4)

Örebro University Hospital

Örebro, Blekinge Län, 70185, Sweden

Location

Uppsala university hospital

Uppsala, Uppsala County, 75105, Sweden

Location

Norrland University Hospital

Umeå, Västerbotten County, 90737, Sweden

Location

Sahlgrenska university hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

Related Publications (1)

• Langegard U, Cajander A, Carlsson M, von Essen L, Ahmad A, Laurell G, Tiblom Ehrsson Y, Johansson B. Internet-based support for informal caregivers to individuals with head and neck cancer (Carer eSupport): a study protocol for the development and feasibility testing of a complex online intervention. BMJ Open. 2022 May 27;12(5):e057442. doi: 10.1136/bmjopen-2021-057442.

  PMID: 35623759 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Birgitta Johansson, Docent

  Uppsala University, Department of Immunology, Genetics and pathology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group posttest only design

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 31, 2021
• Study Start: April 17, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)