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

February 15, 2024 updated by: Uppsala University

Carer eSupport: Rationale and Design of an Internet-based Support for Informal Caregivers of Individuals With Head and Neck Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Blekinge Län
      • Örebro, Blekinge Län, Sweden, 70185
        • Örebro University Hospital
    • Uppsala Län
      • Uppsala, Uppsala Län, Sweden, 75105
        • Uppsala University Hospital
    • Västerbottens Län
      • Umeå, Västerbottens Län, Sweden, 90737
        • Norrland University Hospital
    • Västra Götaland
      • Göteborg, Västra Götaland, Sweden, 41345
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Internet based support
Internet based support for informal caregivers to individuals who are undergoing treatment for head and neck cancer.
Other: Internet based support
Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.
Other Names:
  • Carer eSupport

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inclusion rate
Time Frame: 4 months
The proportion of caregivers who give informed consent for participation
4 months
Utilization of Carer eSupport
Time Frame: 2 months
The proportion of included caregivers who take use of Carer eSupport
2 months
Attrition
Time Frame: 3 months
The proportion of included caregivers who withdraw from the study
3 months
Completion of questionnaires
Time Frame: 3 months
The proportion of included caregivers who complete questionnaires
3 months
Perceived feasibility
Time Frame: Within 1 months after completion of testing Carer eSupport.
Qualitative data from semi-structured individual interviews exploring perceived feasibility of Carer eSupport.
Within 1 months after completion of testing Carer eSupport.
Perceived acceptability
Time Frame: Within 1 months after completion of testing Carer eSupport.
Qualitative data from semi-structured individual interviews exploring perceived acceptability of Carer eSupport.
Within 1 months after completion of testing Carer eSupport.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Preparedness for caregiving scale
Time Frame: Assessed at baseline and at 1 months after access to Carer eSupport
A brief 8-item self-report measure assessing preparedness for caregiving, a potential primary outcome in a future randomized controlled trial.
Assessed at baseline and at 1 months after access to Carer eSupport
Caregiver´s burden scale
Time Frame: Assessed at baseline and at 1 months after access to Carer eSupport.
A 22-item self-report measure assessing caregiver burden, a potential primary outcome in a future randomized controlled trial.
Assessed at baseline and at 1 months after access to Carer eSupport.
Short Form Health Survey (SF-36), v2.
Time Frame: Assessed at baseline and at 1 months after access to Carer eSupport.
A 36-item self-report measure assessing self-perceived health, a potential secondary outcome in a future randomized controlled trial.
Assessed at baseline and at 1 months after access to Carer eSupport.
The Depression Anxiety Stress Scale-21
Time Frame: Assessed at baseline and at 1 months after access to Carer eSupport.
A 21-item self-report measure assessing depression, anxiety, and stress, a potential secondary outcome in a future randomized controlled trial.
Assessed at baseline and at 1 months after access to Carer eSupport.
The Multidimensional fatigue inventory
Time Frame: Assessed at baseline and at 1 months after access to Carer eSupport.
A 20-item self-report measure assessing five dimensions of fatigue, a potential secondary outcome in a future randomized controlled trial.
Assessed at baseline and at 1 months after access to Carer eSupport.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Swedish Research Council
Region Örebro County
Region Västerbotten
Uppsala University Hospital
Swedish Cancer Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Birgitta Johansson, Docent, Uppsala University, Department of Immunology, Genetics and pathology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Carer eSupport

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers, since this is a feasibility study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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