Clinical trial NCT04437563: Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention
Official title: Improving Information to Caregivers Via Adaptation and Implementation of the HERMES Intervention the Danish Health Care System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Cancer
Informal caregivers
Information
Intervention
Stepped wedge cluster randomized controlled trial
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Gentofte University Hospital, Denmark
name: Rigshospitalet, University of Copenhagen, Denmark
name: South Jutland Hospital, Denmark
First posted: 2020-06-18
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of information from and communication with health care professionals
timeFrame: Change from baseline (enrollment) to 3 months follow-up
Secondary outcomes:
measure: Quality of information from and communication with health care professionals
timeFrame: Change from baseline (enrollment) to 6 months follow-up
measure: Amount of information from health care professionals
timeFrame: Change from baseline (enrollment) to 3 months follow-up
measure: Amount of information from health care professionals
timeFrame: Change from baseline (enrollment) to 6 months follow-up
measure: Attention from health care professionals
timeFrame: Change from baseline (enrollment) to 3 months follow-up
measure: Attention from health care professionals
timeFrame: Change from baseline (enrollment) to 6 months follow-up
measure: Caregiver involvement
timeFrame: Change from baseline (enrollment) to 3 months follow-up
measure: Caregiver involvement
timeFrame: Change from baseline (enrollment) to 6 months follow-up
measure: Emotional functioning
timeFrame: Change from baseline (enrollment) to 3 months follow-up
measure: Emotional functioning
timeFrame: Change from baseline (enrollment) to 6 months follow-up
measure: Positive emotional functioning
timeFrame: Change from baseline (enrollment) to 3 months follow-up
measure: Positive emotional functioning
timeFrame: Change from baseline (enrollment) to 6 months follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Herning
country: Denmark
facility: Hospitalsenheden Vest
city: Naestved
country: Denmark
facility: Naestved Sygehus
city: Roskilde
country: Denmark
facility: Roskilde Universitetshospital
city: Soenderborg
country: Denmark
facility: Sygehus Soenderjylland
city: Vejle
country: Denmark
facility: Vejle Sygehus
Study officials:
affiliation: Bispebjerg and Frederiksberg Hospital, University of Copenhagen
name: Mogens Groenvold, PhD DMSc
role: PRINCIPAL_INVESTIGATOR
References: