Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)

Multiple Myeloma Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444348
• Other study ID #: P-2022-93
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: Rigshospitalet, Denmark
• Contact: Cæcilie Borregaard Myrhøj, MScN
• Phone: +45 60701620
• Email: caecilie.borregaard.myrhoej[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 920
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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): in palliative treatment or relapse

• Lymphoma: age=80 or relapse or refractory or palliative treatment

• Multiple myeloma(MM): 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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Death
• Hematologic Diseases
• Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndromes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Denmark	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

Sponsors (9)

Lead Sponsor	Collaborator
Christoffer Johansen	Aalborg University Hospital, Aarhus University Hospital, Gødstrup Hospital, Hospital of South West Jutland, Odense University Hospital, Rigshospitalet, Denmark, Vejle Hospital, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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	Number of Days of hospitalized in the last 30 days of life	Counts of days in hospital in the last 30 days of life of deceased patients	30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Secondary	Number of medical consultations, in the last 30 days of life	Counts of medical consultation in the last 30 days of life of deceased patients	30 days prior to date of death,if patient dies within 18 months of follow-up period of the study
Secondary	Number of patients with referral to hospice in the last 30 days of life	Referral to hospice and days from referral to death	30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Secondary	Survival	Overall survival	days from diagnosis to death, if patient dies within 18 months follow-up period of the study
Secondary	Change from baseline through 3,6,9,12 and 18 months follow-up in Patient's quality of life	Patient reported outcome using European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire Core 15 item palliative, 4-point scale, minimum value: 1 max value 4, higher score 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	Change from baseline through 3,6,9,12 and 18 months follow-up in patients' depressive symptoms	Patient reported outcome of depression (patient Health Questionaires), 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	Change from baseline through 3,6,9,12 and 18 months follow-up in caregivers' depressive symptoms	Caregiver reported outcome of depression (patient Health Questionaires), 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	Change from baseline through 3,6,9,12 and 18 months follow-up in patient's social support	Patient reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"	baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Secondary	Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's social support	Caregiver reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"	baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Secondary	Change from baseline through 3,6,9,12 and 18 months follow-up in patient's relationship quality	Patient reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality	baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Secondary	Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's relationship quality	Caregiver reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality	baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
Secondary	Change from baseline through 3,6,9,12 and 18 months follow-up in patient's satisfaction with health care	Patient reported outcome: Family Satisfaction With Advanced Cancer Care, measure on a 5-point scale where 1 is best and 5 is worst.	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	Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's satisfaction with health care	Caregiver reported outcome: Family Satisfaction With Advanced Cancer Care, measure on a 5-point scale where 1 is best and 5 is worst.	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	Change from baseline through 3,6,9,12 and 18 months follow-up in patient's prognostic understanding	Patient reported outcome: Prognostic understanding, single item questionnaire	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	Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver Prognostic understanding	Caregiver reported outcome: Prognostic understanding, single item questionnaire	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	Patient satisfaction with intervention sessions	Patient reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.	7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
Secondary	Caregiver Satisfaction with intervention sessions	Caregiver reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.	7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
Secondary	Bereaved caregivers' depressive symptoms	Caregiver reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.	1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.
Secondary	Bereaved caregivers' 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.	1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study
Secondary	Post-traumatic stress	Bereaved caregiver reported outcome: post-traumatic stress using questionnaire "Impact of Events Scale- revised", assesses subjective distress caused by traumatic events, Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Higher score worse outcome	1 and 6 months after patient's death, if patient dies within 18 months of follow-up period of the study
Secondary	Perception of the patient's quality of death	Bereaved caregiver reported outcome: Perception of the patient's quality of death, The Views Of Informal Carers - Evaluation of Services - Short Form.	One months after patient's death, if patient dies within 18 months of follow-up period of the study
Secondary	Prolonged Grief	Bereaved caregiver reported outcome: Prolonged Grief disorder. using a 5-point scale from 1-5, Higher score means worse outcome	six months after patient's death, if patient dies within 18 months of follow-up period of the study
Secondary	Self-efficacy - advance care planning	Clinician reported outcome: Advance care planning self-efficacy, 5 point scale from 1-5, higher score is better outcome	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.
Secondary	Burnout	Clinician reported outcome: burnout (Copenhagen Burnout Inventory) 5-point scale, value 0-5, higher score means worse outcome	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.
Secondary	Existential communication	Clinician reported outcome: Existential communication, 5 point scale from 1-5, higher score is better outcome.	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.
Secondary	Satisfaction with intervention	Clinician reported outcome: satisfaction with intervention, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.	After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,