Clinical trial NCT05444348: Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)
Official title: Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Myelodysplastic Syndromes
Lymphoma
Acute Myeloid Leukemia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Zealand University Hospital
name: Odense University Hospital
name: Vejle Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Gødstrup Hospital
name: Aarhus University Hospital
name: Aalborg University Hospital
First posted: 2022-07-05
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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
* 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:

Patient and caregiver are excluded if one of them is:

- Suffering from a severe psychiatric disorder

Physicians and nurses:

- If they do not meet the inclusion criterion.

Primary outcomes:
measure: Use of chemotherapy within the last 30 days of life.
timeFrame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in patient's anxiety symptoms
timeFrame: 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.
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's anxiety symptoms
timeFrame: 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:
measure: Number of Days of hospitalized in the last 30 days of life
timeFrame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
measure: Number of medical consultations, in the last 30 days of life
timeFrame: 30 days prior to date of death,if patient dies within 18 months of follow-up period of the study
measure: Number of patients with referral to hospice in the last 30 days of life
timeFrame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
measure: Survival
timeFrame: days from diagnosis to death, if patient dies within 18 months follow-up period of the study
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in Patient's quality of life
timeFrame: 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.
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in patients' depressive symptoms
timeFrame: 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.
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in caregivers' depressive symptoms
timeFrame: 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.
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in patient's social support
timeFrame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's social support
timeFrame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in patient's relationship quality
timeFrame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's relationship quality
timeFrame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in patient's satisfaction with health care
timeFrame: 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.
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's satisfaction with health care
timeFrame: 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.
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in patient's prognostic understanding
timeFrame: 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.
measure: Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver Prognostic understanding
timeFrame: 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.
measure: Patient satisfaction with intervention sessions
timeFrame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
measure: Caregiver Satisfaction with intervention sessions
timeFrame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
measure: Bereaved caregivers' depressive symptoms
timeFrame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.
measure: Bereaved caregivers' anxiety symptoms
timeFrame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study
measure: Post-traumatic stress
timeFrame: 1 and 6 months after patient's death, if patient dies within 18 months of follow-up period of the study
measure: Perception of the patient's quality of death
timeFrame: One months after patient's death, if patient dies within 18 months of follow-up period of the study
measure: Prolonged Grief
timeFrame: six months after patient's death, if patient dies within 18 months of follow-up period of the study
measure: Self-efficacy - advance care planning
timeFrame: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
measure: Burnout
timeFrame: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
measure: Existential communication
timeFrame: Baseline, and after completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year, and after 24 months of intervention.
measure: Satisfaction with intervention
timeFrame: After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Esbjerg
country: Denmark
facility: Sydvestjysk sygehus - Esbjerg
city: Herning
country: Denmark
facility: Regionshospitalet Gødstrup
city: Odense
country: Denmark
facility: Odense Universitetshospital
city: Roskilde
country: Denmark
facility: Sjællands universitetshospital Roskilde
city: Vejle
country: Denmark
facility: Lillebælt syge - Vejle Sygehus
Study officials:
affiliation: Rigshospitalet, Denmark
name: Christoffer Johansen, Professor
role: PRINCIPAL_INVESTIGATOR
References: