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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
920
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.
Aalborg Universitetshospital
Aalborg, Denmark
RECRUITINGAarhus Universitetshospital
Aarhus, Denmark
RECRUITINGSydvestjysk sygehus - Esbjerg
Esbjerg, Denmark
RECRUITINGRegionshospitalet Gødstrup
Herning, Denmark
RECRUITINGOdense Universitetshospital
Odense, Denmark
RECRUITINGSjællands universitetshospital Roskilde
Roskilde, Denmark
RECRUITINGLillebælt syge - Vejle Sygehus
Vejle, Denmark
RECRUITINGUse of chemotherapy within the last 30 days of life.
Counts of patients receiving chemotherapy in the last 30 days of their life
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Time frame: 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
Counts of medical consultation in the last 30 days of life of deceased patients
Time frame: 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
Referral to hospice and days from referral to death
Time frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
Survival
Overall survival
Time frame: 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
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
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 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"
Time frame: 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 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"
Time frame: 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 relationship quality
Patient reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality
Time frame: 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 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
Time frame: 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.
Time frame: 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.
Time frame: 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 patient's prognostic understanding
Patient reported outcome: Prognostic understanding, single item questionnaire
Time frame: 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 Prognostic understanding
Caregiver reported outcome: Prognostic understanding, single item questionnaire
Time frame: 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 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.
Time frame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
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.
Time frame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
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.
Time frame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.
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.
Time frame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study
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
Time frame: 1 and 6 months after patient's death, if patient dies within 18 months of follow-up period of the study
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.
Time frame: One months after patient's death, if patient dies within 18 months of follow-up period of the study
Prolonged Grief
Bereaved caregiver reported outcome: Prolonged Grief disorder. using a 5-point scale from 1-5, Higher score means worse outcome
Time frame: six months after patient's death, if patient dies within 18 months of follow-up period of the study
Self-efficacy - advance care planning
Clinician reported outcome: Advance care planning self-efficacy, 5 point scale from 1-5, higher score is better outcome
Time frame: 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.
Burnout
Clinician reported outcome: burnout (Copenhagen Burnout Inventory) 5-point scale, value 0-5, higher score means worse outcome
Time frame: 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.
Existential communication
Clinician reported outcome: Existential communication, 5 point scale from 1-5, higher score is better outcome.
Time frame: 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.
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.
Time frame: After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,
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