Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention (HERMESII)

March 1, 2022 updated by: Mogens Groenvold, Bispebjerg Hospital

Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention the Danish Health Care System

The HERMES intervention was developed in a Danish setting after a comprehensive investigation on caregivers' needs. The intervention consists of: 1) a systematic identification of the caregiver's unmet information needs and 2) a subsequent consultation with a nurse providing the lacking information. The evaluation carried out in a randomized trial at Herlev Hospital showed positive results. It reduced the unmet information needs and improved the caregivers' evaluation of the information from and communication with the health care professionals and the perception of being seen and acknowledged as a caregiver. However, although research projects may show a positive effect, this does not mean that the intervention will be easily implemented in the health care system. Nor does it guarantee that the intervention will show the expected results once implemented in a busy clinical routine.

Therefore, the present project will adapt the HERMES intervention to be implemented in Danish departments of oncology and haematology by (in the first part of the project):

  1. Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
  2. Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
  3. Developing a technological solution (an app) for the HERMES intervention in which the responses given by the caregivers will form the basis for a subsequent consultation with the health care staff.
  4. Revising the HERMES intervention based on the outcomes of a-c.
  5. Testing the revised HERMES intervention in a pilot study.

In the second part of the project, the revised HERMES intervention will be tested in a large scale trial with the purpose to:

  1. Implement the revised HERMES intervention in the departments of oncology/haematology.
  2. Test the effect of the revised HERMES intervention.
  3. Evaluate the feasibility of the revised HERMES intervention in a large scale.
  4. Elucidate the effectiveness and the feasibility of the intervention and assess possibilities and potential needs for further adaptation in order to secure the future applicability in the Danish Health Care System.

Thus, the overall aim is that by the end of the study, an evidence based and practical implementable method to (continous) use of the HERMES intervention in the Danish health care system is available.

Study Overview

Status

Status

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

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 (Anticipated)

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.
1500

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 Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Aalborg Universitetshospital
        • Contact:
      • Copenhagen, Denmark, 2100
      • Herlev, Denmark
      • Herning, Denmark
        • Recruiting
        • Hospitalsenheden Vest
        • Contact:
      • Naestved, Denmark
      • Roskilde, Denmark
      • Soenderborg, Denmark
      • Vejle, Denmark

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult (18+ years)
  • Primary caregiver (defined as the lay person (partner, family member, friend, etc) most involved in the patient's disease course. The primary caregiver is appointed by the patient)
  • Caregiver of an adult cancer patient starting up a treatment course in an oncological department
  • Written informed consent to participation

Exclusion Criteria:

  • Caregivers not able to read and understand Danish
  • Caregivers with no or minimal contact to the oncological department

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel 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.
No Intervention: Control
('Standard' care). No intervention offered.
Experimental: Intervention
('Standard' care +) The 'Herlev Hospital Empowerment of Relatives through More and Earlier information Supply' (HERMES) intervention.
Behavioral: HERMES
Via an app, the caregiver answers 14 questions about his/her need for (more) information. The caregiver presents his/her answers (i.e., need for information) to the health care professionals (HCPs), and the HCPs provide the caregiver with the lacking information.

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
Quality of information from and communication with health care professionals
Time Frame: Change from baseline (enrollment) to 3 months follow-up
Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.
Change from baseline (enrollment) to 3 months follow-up

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
Quality of information from and communication with health care professionals
Time Frame: Change from baseline (enrollment) to 6 months follow-up
Measured by the subscale 'Problems with the quality of information from and communication with health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more problems with the quality of information from and communication with health care professionals.
Change from baseline (enrollment) to 6 months follow-up
Amount of information from health care professionals
Time Frame: Change from baseline (enrollment) to 3 months follow-up
Measured by (a revised version of) the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals
Change from baseline (enrollment) to 3 months follow-up
Amount of information from health care professionals
Time Frame: Change from baseline (enrollment) to 6 months follow-up
Measured by (a revised version of) the subscale 'Lack of information from health care professionals' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of information from health care professionals
Change from baseline (enrollment) to 6 months follow-up
Attention from health care professionals
Time Frame: Change from baseline (enrollment) to 3 months follow-up
Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals
Change from baseline (enrollment) to 3 months follow-up
Attention from health care professionals
Time Frame: Change from baseline (enrollment) to 6 months follow-up
Measured by the subscale 'Lack of attention from health care professionals on the caregivers' wellbeing' in the Cancer Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. more lack of attention from health care professionals
Change from baseline (enrollment) to 6 months follow-up
Caregiver involvement
Time Frame: Change from baseline (enrollment) to 3 months follow-up
Measured by item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement
Change from baseline (enrollment) to 3 months follow-up
Caregiver involvement
Time Frame: Change from baseline (enrollment) to 6 months follow-up
Measured by item 12 in the Caregiving Tasks, Consequences and Needs Questionnaire (CaTCoN). Item score range: 0-100. A higher score represents a worse outcome, i.e. more caregiver dissatisfaction with involvement
Change from baseline (enrollment) to 6 months follow-up
Emotional functioning
Time Frame: Change from baseline (enrollment) to 3 months follow-up
Measured by the European Organisation for Research and Treatment of Cancer (EORTC) Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning
Change from baseline (enrollment) to 3 months follow-up
Emotional functioning
Time Frame: Change from baseline (enrollment) to 6 months follow-up
Measured by the EORTC Emotional Functioning 10 scale (EORTC EF10). Subscale score range: 0-100. A higher score represents a worse outcome, i.e. worse emotional functioning
Change from baseline (enrollment) to 6 months follow-up
Positive emotional functioning
Time Frame: Change from baseline (enrollment) to 3 months follow-up
Measured by a scale of five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Subscale score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning
Change from baseline (enrollment) to 3 months follow-up
Positive emotional functioning
Time Frame: Change from baseline (enrollment) to 6 months follow-up
Measured by a scale of five positively formulated items concerning emotional functioning which were excluded from the EORTC Computerized Adaptive Test (CAT) emotional functioning bank during the development of the item bank. Subscale score range: 0-100. A higher score represents a better outcome, i.e. more positive emotional functioning
Change from baseline (enrollment) to 6 months follow-up

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.
Bispebjerg Hospital

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.
Herlev Gentofte University Hospital, Denmark
Rigshospitalet, University of Copenhagen, Denmark
South Jutland Hospital, Denmark

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: Mogens Groenvold, PhD DMSc, Bispebjerg and Frederiksberg Hospital, University of Copenhagen

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.
February 1, 2021

Primary Completion (Anticipated)

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.
April 15, 2022

Study Completion (Anticipated)

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.
July 15, 2022

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).
June 16, 2020

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.
June 16, 2020

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.
June 18, 2020

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.
March 2, 2022

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.
March 1, 2022

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.
March 1, 2022

More Information

Terms related to this study

Keywords

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.
  • R210-A12901

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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