CancerHERMESIINCT04437563
Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention
A study testing HERMES in people with Cancer, run by Bispebjerg Hospital at 8 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- HERMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 8 sitesDenmark
- Study dates
- 1 Feb 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Caregivers not able to read and understand Danish
- Caregivers with no or minimal contact to the oncological department
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites, 8 recruiting
- Recruiting
Aalborg Universitetshospital
Aalborg
Charlotte B Rotboel, MD, c.rotboel@rn.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Ulla B Tange, MD, ulla.brix.tange@regionh.dk
- Recruiting
Herlev Hospital
Herlev
Katrine R Jervad, Nurse, katrine.roshani.jervad@regionh.dk
- Recruiting
Hospitalsenheden Vest
Herning
Hanne Linnet, MD, hannsind@rm.dk
- Recruiting
Naestved Sygehus
Næstved
Elizabeth Rosted, PhD, Nurse, eros@regionsjaelland.dk
- Recruiting
Roskilde Universitetshospital
Roskilde
Elizabeth Rosted, PhD, Nurse, eros@regionsjaelland.dk
- Recruiting
Sygehus Soenderjylland
Sønderborg
Joan Lassen, Nurse, joan.lassen@rsyd.dk
- Recruiting
Vejle Sygehus
Vejle
Hroenn Thorn, Nurse, hronn.thorn@rsyd.dk
About this study
Official title: 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):
Read more
- Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
- Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
- 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.
- Revising the HERMES intervention based on the outcomes of a-c.
- 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:
- Implement the revised HERMES intervention in the departments of oncology/haematology.
- Test the effect of the revised HERMES intervention.
- Evaluate the feasibility of the revised HERMES intervention in a large scale.
- 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.
- Conditions
- Cancer
- Being tested
- HERMES
- Keywords
- Cancer, Informal caregivers, Information, Intervention, Stepped wedge cluster randomized controlled trial
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HERMESBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | ('Standard' care). No intervention offered. |
| Intervention | Experimental | ('Standard' care +) The 'Herlev Hospital Empowerment of Relatives through More and Earlier information Supply' (HERMES) intervention. Receives: Behavioral: HERMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of information from and communication with health care professionals
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.
Measured: Change from baseline (enrollment) to 3 months follow-up
Secondary outcomes (11)
Quality of information from and communication with health care professionals
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.
Measured: Change from baseline (enrollment) to 6 months follow-up
Amount of information from health care professionals
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
Measured: Change from baseline (enrollment) to 3 months follow-up
Amount of information from health care professionals
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
Measured: Change from baseline (enrollment) to 6 months follow-up
Attention from health care professionals
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
Measured: Change from baseline (enrollment) to 3 months follow-up
Attention from health care professionals
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
Measured: Change from baseline (enrollment) to 6 months follow-up
Caregiver involvement
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
Measured: Change from baseline (enrollment) to 3 months follow-up
Caregiver involvement
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
Measured: Change from baseline (enrollment) to 6 months follow-up
Emotional functioning
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
Measured: Change from baseline (enrollment) to 3 months follow-up
Emotional functioning
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
Measured: Change from baseline (enrollment) to 6 months follow-up
Positive emotional functioning
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
Measured: Change from baseline (enrollment) to 3 months follow-up
Positive emotional functioning
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
Measured: Change from baseline (enrollment) to 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Feb 2021
- Primary completion15 Apr 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A stepped wedge cluster randomized controlled trial. All clusters (i.e., participating oncological departments) will start as controls and will change to intervention at various times determined by randomization. In this way, all departments will contribute to control and intervention groups, thus accounting for variation between departments.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Gentofte University Hospital, Denmark, Copenhagen University Hospital, Rigshospitalet, South Jutland Hospital, Denmark
- Responsible party
- Principal investigator, Mogens Groenvold, Bispebjerg Hospital
- Investigators
- Mogens Groenvold, PhD DMSc, Principal investigator, Bispebjerg and Frederiksberg Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437563
- Sponsor's protocol ID
- R210-A12901
- Acronym
- HERMESII
- Status last verified
- Mar 2022
- First submitted
- 16 Jun 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention the Danish Health Care System
- ClinicalTrials.gov ID
- NCT04437563
- Acronym / sponsor ID
- HERMESII / R210-A12901
- Conditions
- Cancer
- Keywords
- Cancer, Informal caregivers, Information, Intervention, Stepped wedge cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Herlev Gentofte University Hospital, Denmark, Copenhagen University Hospital, Rigshospitalet, South Jutland Hospital, Denmark
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- Elucidating how the HERMES intervention is best implemented in the clinical setting according to the clinical staff.
- Elucidating how the HERMES intervention is best implemented in the treatment and follow-up period according to the patients and their caregivers.
- 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.
- Revising the HERMES intervention based on the outcomes of a-c.
- 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:
- Implement the revised HERMES intervention in the departments of oncology/haematology.
- Test the effect of the revised HERMES intervention.
- Evaluate the feasibility of the revised HERMES intervention in a large scale.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stepped wedge cluster randomized controlled trial. All clusters (i.e., participating oncological departments) will start as controls and will change to intervention at various times determined by randomization. In this way, all departments will contribute to control and intervention groups, thus accounting for variation between departments.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –('Standard' care). No intervention offered. |
| Intervention | Experimental | Behavioral: HERMES('Standard' care +) The 'Herlev Hospital Empowerment of Relatives through More and Earlier information Supply' (HERMES) intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Caregivers not able to read and understand Danish
- Caregivers with no or minimal contact to the oncological department
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HERMESVia 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. | Behavioural | Intervention |
Primary outcome
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.
11 secondary outcomes
Quality of information from and communication with health care professionals
Time frame: 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
Amount of information from health care professionals
Time frame: 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
Attention from health care professionals
Time frame: Change from baseline (enrollment) to 6 months follow-up
Caregiver involvement
Time frame: Change from baseline (enrollment) to 3 months follow-up
Caregiver involvement
Time frame: Change from baseline (enrollment) to 6 months follow-up
Emotional functioning
Time frame: Change from baseline (enrollment) to 3 months follow-up
Emotional functioning
Time frame: Change from baseline (enrollment) to 6 months follow-up
Positive emotional functioning
Time frame: Change from baseline (enrollment) to 3 months follow-up
Positive emotional functioning
Time frame: Change from baseline (enrollment) to 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mogens Groenvold, PhD DMSc principal investigator
Bispebjerg and Frederiksberg Hospital, University of Copenhagen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HERMES in people with Cancer, run by Bispebjerg Hospital at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Adsersen, PhD (004538635131, mathilde.adsersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of information from and communication with health care professionals (time frame: Change from baseline (enrollment) to 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.