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

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

Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study

Rigshospitalet, Denmark, Zealand University Hospital, Odense University Hospital, Vejle Hospital, Hospital of South West Jutland, Gødstrup Hospital, Aarhus University Hospital, Aalborg University Hospital

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.

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.

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.

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.

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.

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.

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.

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

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

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

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

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.

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.

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.

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.

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

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

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.

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

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

Bereaved caregiver reported outcome: Perception of the patient's quality of death, The Views Of Informal Carers - Evaluation of Services - Short Form.

Bereaved caregiver reported outcome: Prolonged Grief disorder. using a 5-point scale from 1-5, Higher score means worse outcome

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.

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.

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.

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,

Inclusion Criteria: Patients must: Be at least 18 years of age Have a diagnosis of one of the following: High risk myelodysplastic syndrome, acute myeloid leukemia in palliative treatment, relapsed or refractory lymphoma or in palliative treatment, relapsed or refractory multiple myeloma 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.