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

Cancer Clinical Trial

— HERMESII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04437563
• Other study ID #: R210-A12901
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: March 2022
• Source: Bispebjerg Hospital
• Contact: Mathilde Adsersen, PhD
• Phone: 004538635131
• Email: mathilde.adsersen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: July 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

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.

Locations

Country	Name	City	State
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Hospitalsenheden Vest	Herning
Denmark	Naestved Sygehus	Naestved
Denmark	Roskilde Universitetshospital	Roskilde
Denmark	Sygehus Soenderjylland	Soenderborg
Denmark	Vejle Sygehus	Vejle

Sponsors (4)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Herlev Gentofte University Hospital, Denmark, Rigshospitalet, University of Copenhagen, Denmark, South Jutland Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline (enrollment) to 3 months follow-up
Secondary	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.	Change from baseline (enrollment) to 6 months follow-up
Secondary	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	Change from baseline (enrollment) to 3 months follow-up
Secondary	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	Change from baseline (enrollment) to 6 months follow-up
Secondary	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	Change from baseline (enrollment) to 3 months follow-up
Secondary	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	Change from baseline (enrollment) to 6 months follow-up
Secondary	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	Change from baseline (enrollment) to 3 months follow-up
Secondary	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	Change from baseline (enrollment) to 6 months follow-up
Secondary	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	Change from baseline (enrollment) to 3 months follow-up
Secondary	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	Change from baseline (enrollment) to 6 months follow-up
Secondary	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	Change from baseline (enrollment) to 3 months follow-up
Secondary	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	Change from baseline (enrollment) to 6 months follow-up