Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)
ACT
1 other identifier
interventional
920
1 country
7
Brief Summary
Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Patients with hematological cancers frequently have poor end of life outcomes, such as high treatment activity close to death, where clinical effects are doubtful, and low utilization of palliative care. Prognostic awareness and end of life (EOL) issues have urgency in the communication between patients, their caregiving relatives, and clinicians, in order to avoid futile treatments and suffering at EOL. Inspired by advanced care planning, the investigators developed the concept "Advance Consultations Concerning participants Life and Treatment" (ACT) in collaboration with a group consisting of hematologists, nurses, patients, and caregivers. The ACT concept consists of an 8-hour training day for clinicians, clinical tools, system changes, and preparation material for patients and caregivers prior to the consultation. ACT involves patients and caregivers earlier in preparation for life with chronic progressive disease and EOL-decisions, through an intervention based on compassionate communication and early planning of EOL-care. The aim of the study is to investigate the effect of the intervention on use of chemotherapy and quality of EOL-care in patients with hematological malignancy. Based on the results of the completed pilot study, the investigators are planning a nationwide 2-arm cluster randomized controlled trial where 40 physicians and 80 nurses across seven different hematological departments are randomized to either usual care or ACT training and completing ACT conversations. The investigators expect to include a total of 400 patients and their family caregivers. It is hypothesized that the ACT intervention will decrease use of futile chemotherapy, prepare patients and caregivers for difficult end-of-life-decisions, and improve quality of end-of-life care in hematology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-myeloma
Started Aug 2022
Typical duration for not_applicable multiple-myeloma
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
July 29, 2025
July 1, 2025
4.2 years
May 19, 2022
July 24, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Use of chemotherapy within the last 30 days of life.
Counts of patients receiving chemotherapy in the last 30 days of their life
30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's anxiety symptoms
Patient reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
baseline, 3,6,9,12, and 18 months of follow-up. Investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's anxiety symptoms
Caregiver reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
Secondary Outcomes (26)
Number of Days of hospitalized in the last 30 days of life
30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Number of medical consultations, in the last 30 days of life
30 days prior to date of death,if patient dies within 18 months of follow-up period of the study
Number of patients with referral to hospice in the last 30 days of life
30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Survival
days from diagnosis to death, if patient dies within 18 months follow-up period of the study
Change from baseline through 3,6,9,12 and 18 months follow-up in Patient's quality of life
baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated measurements at 3, 6, 9, 12, and 18, months follow-up.
- +21 more secondary outcomes
Study Arms (2)
ACT intervention
EXPERIMENTALParticipants will receive the ACT intervention
control
NO INTERVENTIONParticipants will receive no intervention only usual care.
Interventions
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
You may qualify if:
- Patients must:
- 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
- +5 more criteria
You may not qualify if:
- Patient and caregiver are excluded if one of them is:
- \- Suffering from a severe psychiatric disorder
- Physicians and nurses:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Christoffer Johansenlead
- Rigshospitalet, Denmarkcollaborator
- Zealand University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Vejle Hospitalcollaborator
- Esbjerg Hospital - University Hospital of Southern Denmarkcollaborator
- Gødstrup Hospitalcollaborator
- Aarhus University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
Study Sites (7)
Aalborg Universitetshospital
Aalborg, 9100, Denmark
Aarhus Universitetshospital
Aarhus, 8200, Denmark
Sydvestjysk sygehus - Esbjerg
Esbjerg, 6700, Denmark
Regionshospitalet Gødstrup
Herning, 7400, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Sjællands universitetshospital Roskilde
Roskilde, 4000, Denmark
Lillebælt syge - Vejle Sygehus
Vejle, 7100, Denmark
Related Publications (1)
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.
PMID: 38772898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoffer Johansen, Professor
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor MD, PhD, DMsc (Med)
Study Record Dates
First Submitted
May 19, 2022
First Posted
July 5, 2022
Study Start
August 1, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ANALYTIC CODE
Access to protocol and statistical code, as well as Individual participation data (IPD) for meta-analysis will be possible upon request. Data requestors will need to sign a data access agreement in agreement with the Data Protection Act.