Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer
Primary Purpose
Caregivers, Head and Neck Cancer, Feasibility Study
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet based support
Sponsored by
About this trial
This is an interventional supportive care trial for Caregivers
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Confusion or dementia, inability to understand, speak or read Swedish.
Sites / Locations
- Örebro University HospitalRecruiting
- Uppsala university hospitalRecruiting
- Norrland University HospitalRecruiting
- Sahlgrenska university hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Internet based support
Arm Description
Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.
Outcomes
Primary Outcome Measures
Inclusion rate
The proportion of caregivers who give informed consent for participation
Utilization of Carer eSupport
The proportion of included caregivers who take use of Carer eSupport
Attrition
The proportion of included caregivers who withdraw from the study
Completion of questionnaires
The proportion of included caregivers who complete questionnaires
Perceived feasibility
Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.
Perceived acceptability
Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.
Secondary Outcome Measures
The Preparedness for caregiving scale
A brief 8-item self-report measure assessing preparedness for caregiving, a potential primary outcome in a future randomized controlled trial.
Caregiver´s burden scale
A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial.
Short Form Health Survey (SF-36), v2.
A 36-item self-report measure assessing self-perceived health, a potential secondary outcome in a future randomized controlled trial.
The Depression Anxiety Stress Scale-21
A 21-item self-report measure assessing depression, anxiety, and stress, a potential secondary outcome in a future randomized controlled trial.
The Multidimensional fatigue inventory
A 20-item self-report measure assessing five dimensions of fatigue, a potential secondary outcome in a future randomized controlled trial.
Full Information
NCT ID
NCT05028452
First Posted
August 24, 2021
Last Updated
May 10, 2023
Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Swedish Cancer Society, Uppsala University Hospital, Region Västerbotten, Region Örebro County
1. Study Identification
Unique Protocol Identification Number
NCT05028452
Brief Title
Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer
Official Title
Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
The Swedish Research Council, Swedish Cancer Society, Uppsala University Hospital, Region Västerbotten, Region Örebro County
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Head and Neck Cancer, Feasibility Study
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group posttest only design
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet based support
Arm Type
Other
Arm Description
Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.
Intervention Type
Other
Intervention Name(s)
Internet based support
Other Intervention Name(s)
Carer eSupport
Intervention Description
Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.
Primary Outcome Measure Information:
Title
Inclusion rate
Description
The proportion of caregivers who give informed consent for participation
Time Frame
4 months
Title
Utilization of Carer eSupport
Description
The proportion of included caregivers who take use of Carer eSupport
Time Frame
2 months
Title
Attrition
Description
The proportion of included caregivers who withdraw from the study
Time Frame
3 months
Title
Completion of questionnaires
Description
The proportion of included caregivers who complete questionnaires
Time Frame
3 months
Title
Perceived feasibility
Description
Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.
Time Frame
Within 1 months after completion of testing Carer eSupport.
Title
Perceived acceptability
Description
Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.
Time Frame
Within 1 months after completion of testing Carer eSupport.
Secondary Outcome Measure Information:
Title
The Preparedness for caregiving scale
Description
A brief 8-item self-report measure assessing preparedness for caregiving, a potential primary outcome in a future randomized controlled trial.
Time Frame
Assessed at baseline and at 1 months after access to Carer eSupport
Title
Caregiver´s burden scale
Description
A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial.
Time Frame
Assessed at baseline and at 1 months after access to Carer eSupport.
Title
Short Form Health Survey (SF-36), v2.
Description
A 36-item self-report measure assessing self-perceived health, a potential secondary outcome in a future randomized controlled trial.
Time Frame
Assessed at baseline and at 1 months after access to Carer eSupport.
Title
The Depression Anxiety Stress Scale-21
Description
A 21-item self-report measure assessing depression, anxiety, and stress, a potential secondary outcome in a future randomized controlled trial.
Time Frame
Assessed at baseline and at 1 months after access to Carer eSupport.
Title
The Multidimensional fatigue inventory
Description
A 20-item self-report measure assessing five dimensions of fatigue, a potential secondary outcome in a future randomized controlled trial.
Time Frame
Assessed at baseline and at 1 months after access to Carer eSupport.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Confusion or dementia, inability to understand, speak or read Swedish.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Birgitta Johansson, Docent
Phone
+46704250912
Email
birgitta.johansson@igp.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Ulrica Langegård, PhD
Phone
+46729999020
Email
ulrica.langegard@igp.uu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitta Johansson, Docent
Organizational Affiliation
Uppsala University, Department of Immunology, Genetics and pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebro University Hospital
City
Örebro
State/Province
Blekinge Län
ZIP/Postal Code
70185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Ohlsson-Nevo, Ass prof
Phone
+4619303000
Email
emma.ohlsson-nevo@oru.se
Facility Name
Uppsala university hospital
City
Uppsala
State/Province
Uppsala Län
ZIP/Postal Code
75105
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitta Johansson, Ass prof
Phone
+46706072905
Email
birgitta.johansson@igp.uu.se
First Name & Middle Initial & Last Name & Degree
Birgitta Johansson, Ass prof
Facility Name
Norrland University Hospital
City
Umeå
State/Province
Västerbottens Län
ZIP/Postal Code
90737
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ylva Tiblom Ehrsson, Ass prof
Email
ylva.tiblom.ehrsson@surgsci.uu.se
Facility Name
Sahlgrenska university hospital
City
Göteborg
State/Province
Västra Götaland
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrica Langegård, PhD
Email
mailto:ulrika.langegard@vgregion.se
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers, since this is a feasibility study.
Citations:
PubMed Identifier
35623759
Citation
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.
Results Reference
derived
Learn more about this trial
Feasibility of Internet Based Support (Carer eSupport) for Informal Caregivers of Patients With Head and Neck Cancer
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