Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)
NCT ID: NCT05444348
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
920 participants
INTERVENTIONAL
2022-08-01
2026-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ACT intervention
Participants will receive the ACT intervention
Advance consultation concerning your life and treatment (ACT )
The ACT intervention consists of: an 8 h training day for clinicians including clinical materials such as a conversation aid and conversations guide. 6o minutes ACT-intervention sessions in daily clinic. the patients and caregivers will receive preparatory material prior for the ACT-intervention sessions, and a 30 min follow-up telephone call from the nurse within one week after the ACT-session. Clinicians will receive five sessions of followup supervision within the 24 months of intervention. The 60 min ACT-intervention session is an interdisciplinary conversation with nurse, physician, patient, and caregiver discussing issues of importance of patient and caregiver. The issues are based on the preparatory material focusing on information level and prognosis, patient's and caregiver's values, hopes, fears and worries regarding the future care with progressive disease.
control
Participants will receive no intervention only usual care.
No interventions assigned to this group
Interventions
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Advance consultation concerning your life and treatment (ACT )
The ACT intervention consists of: an 8 h training day for clinicians including clinical materials such as a conversation aid and conversations guide. 6o minutes ACT-intervention sessions in daily clinic. the patients and caregivers will receive preparatory material prior for the ACT-intervention sessions, and a 30 min follow-up telephone call from the nurse within one week after the ACT-session. Clinicians will receive five sessions of followup supervision within the 24 months of intervention. The 60 min ACT-intervention session is an interdisciplinary conversation with nurse, physician, patient, and caregiver discussing issues of importance of patient and caregiver. The issues are based on the preparatory material focusing on information level and prognosis, patient's and caregiver's values, hopes, fears and worries regarding the future care with progressive disease.
Eligibility Criteria
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Inclusion Criteria
* Be at least 18 years of age
* Have a diagnosis of one of the following:
* High-risk myelodysplastic syndrome (MDS) or MDS with overlap of myeloproliferative neoplasms (high-risk MDS/MPN),
* Acute myeloid leukemia(AML): Age≥80 or in palliative treatment or relapse
* Lymphoma: Age≥80 or relapse or refractory or palliative treatment
* Multiple myeloma(MM): Age≥80 or relapsed or refractory
Have limited treatment options. Provide informed consent. Have sufficient Danish skills to complete intervention sessions and data collection
An informal caregiver is identified by the patient as the primary provider of informal physical, practical or emotional support and must:
* Be at least 18 years of age
* Be able to accompany patients to intervention appointments
* Provide informed consent
* Have sufficient Danish skills to complete intervention sessions and data collection
Physicians:
* specialized in hematology
* treating patients with High risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma
* work at the same department for the entire time of intervention.
Nurses:
* treating patients with High-risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma
* work at the same department for the entire time of intervention.
Exclusion Criteria
\- Suffering from a severe psychiatric disorder
Physicians and nurses:
\- If they do not meet the inclusion criterion.
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Zealand University Hospital
OTHER
Odense University Hospital
OTHER
Vejle Hospital
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Gødstrup Hospital
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Christoffer Johansen
OTHER
Responsible Party
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Christoffer Johansen
Professor MD, PhD, DMsc (Med)
Principal Investigators
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Christoffer Johansen, Professor
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus Universitetshospital
Aarhus, , Denmark
Sydvestjysk sygehus - Esbjerg
Esbjerg, , Denmark
Regionshospitalet Gødstrup
Herning, , Denmark
Odense Universitetshospital
Odense, , Denmark
Sjællands universitetshospital Roskilde
Roskilde, , Denmark
Lillebælt syge - Vejle Sygehus
Vejle, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Borregaard Myrhoj C, Clemmensen SN, Jarden M, Johansen C, von Heymann A. Compassionate Communication and Advance Care Planning to improve End-of-life Care in Treatment of Haematological Disease 'ACT': Study Protocol for a Cluster-randomized trial. BMJ Open. 2024 May 21;14(5):e085163. doi: 10.1136/bmjopen-2024-085163.
Other Identifiers
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P-2022-93
Identifier Type: -
Identifier Source: org_study_id
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