- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05444348
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)- a Cluster Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cæcilie Borregaard Myrhøj, MScN
- Phone Number: +45 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
Study Contact Backup
- Name: Annika von Heymann, PhD
- Phone Number: +45 21310881
- Email: annika.von.heymann@regionh.dk
Study Locations
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-
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Aalborg, Denmark, 9100
- Recruiting
- Aalborg Universitetshospital
-
Contact:
- Cæcilie Borregaard Myrhøj
- Phone Number: 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
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Aarhus, Denmark, 8200
- Recruiting
- Aarhus Universitetshospital
-
Contact:
- Cæcilie Borregaard Myrhøj
- Phone Number: 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
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Esbjerg, Denmark, 6700
- Recruiting
- Sydvestjysk sygehus - Esbjerg
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Contact:
- Cæcilie Borregaard Myrhøj
- Phone Number: 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
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Herning, Denmark, 7400
- Recruiting
- Regionshospitalet Gødstrup
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Contact:
- Cæcilie Borregaard Myrhøj
- Phone Number: 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
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Odense, Denmark, 5000
- Recruiting
- Odense Universitetshospital
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Contact:
- Cæcilie Borregaard Myrhøj
- Phone Number: 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
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Roskilde, Denmark, 4000
- Recruiting
- Sjællands Universitetshospital Roskilde
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Contact:
- Cæcilie Borregaard Myrhøj
- Phone Number: 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
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Vejle, Denmark, 7100
- Recruiting
- Lillebælt syge - Vejle Sygehus
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Contact:
- Cæcilie Borregaard Myrhøj
- Phone Number: 60701620
- Email: caecilie.borregaard.myrhoej@regionh.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ACT intervention
Participants will receive the ACT intervention
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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.
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No Intervention: control
Participants will receive no intervention only usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of chemotherapy within the last 30 days of life.
Time Frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
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Counts of patients receiving chemotherapy in the last 30 days of their life
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30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
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Change from baseline through 3,6,9,12 and 18 months follow-up in patient's anxiety symptoms
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 reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
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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.
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Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's anxiety symptoms
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Days of hospitalized in the last 30 days of life
Time Frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
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Counts of days in hospital in the last 30 days of life of deceased patients
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30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
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Number of medical consultations, in the last 30 days of life
Time Frame: 30 days prior to date of death,if patient dies within 18 months of follow-up period of the study
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Counts of medical consultation in the last 30 days of life of deceased patients
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30 days prior to date of death,if patient dies within 18 months of follow-up period of the study
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Number of patients with referral to hospice in the last 30 days of life
Time Frame: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
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Referral to hospice and days from referral to death
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30 days prior to date of death, if patient dies within 18 months of follow-up period of the study
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Survival
Time Frame: days from diagnosis to death, if patient dies within 18 months follow-up period of the study
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Overall survival
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days from diagnosis to death, if patient dies within 18 months follow-up period of the study
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Change from baseline through 3,6,9,12 and 18 months follow-up in Patient's quality of life
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.
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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
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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.
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Change from baseline through 3,6,9,12 and 18 months follow-up in patients' depressive symptoms
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 reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.
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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.
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Change from baseline through 3,6,9,12 and 18 months follow-up in caregivers' depressive symptoms
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.
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Caregiver reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.
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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.
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Change from baseline through 3,6,9,12 and 18 months follow-up in patient's social support
Time Frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
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Patient reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"
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baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
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Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's social support
Time Frame: baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
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Caregiver reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"
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baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
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Change from baseline through 3,6,9,12 and 18 months follow-up in patient's relationship 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
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Patient reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality
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baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea
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Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's relationship 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
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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
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Change from baseline through 3,6,9,12 and 18 months follow-up in patient's satisfaction with health care
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.
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Patient reported outcome: Family Satisfaction With Advanced Cancer Care, measure on a 5-point scale where 1 is best and 5 is worst.
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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
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.
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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.
|
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's prognostic understanding
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.
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Patient reported outcome: Prognostic understanding, single item questionnaire
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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.
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Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver Prognostic understanding
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.
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Caregiver reported outcome: Prognostic understanding, single item questionnaire
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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.
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Patient satisfaction with intervention sessions
Time Frame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
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Patient reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.
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7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
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Caregiver Satisfaction with intervention sessions
Time Frame: 7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
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Caregiver reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.
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7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group
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Bereaved caregivers' depressive symptoms
Time Frame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.
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Caregiver reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.
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1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.
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Perception of the patient's quality of death
Time Frame: One months after patient's death, if patient dies within 18 months of follow-up period of the study
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Bereaved caregiver reported outcome: Perception of the patient's quality of death, The Views Of Informal Carers - Evaluation of Services - Short Form.
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One months after patient's death, if patient dies within 18 months of follow-up period of the study
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Prolonged Grief
Time Frame: six months after patient's death, if patient dies within 18 months of follow-up period of the study
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Bereaved caregiver reported outcome: Prolonged Grief disorder.
using a 5-point scale from 1-5, Higher score means worse outcome
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six months after patient's death, if patient dies within 18 months of follow-up period of the study
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Satisfaction with intervention
Time Frame: After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,
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Clinician reported outcome: satisfaction with intervention, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.
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After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,
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Self-efficacy - advance care planning
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.
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Clinician reported outcome: Advance care planning self-efficacy, 5 point scale from 1-5, higher score is better outcome
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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.
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Burnout
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.
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Clinician reported outcome: burnout (Copenhagen Burnout Inventory) 5-point scale, value 0-5, higher score means worse outcome
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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.
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Existential communication
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.
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Clinician reported outcome: Existential communication, 5 point scale from 1-5, higher score is better outcome.
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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.
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Bereaved caregivers' anxiety symptoms
Time Frame: 1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study
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Caregiver reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.
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1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study
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Post-traumatic stress
Time Frame: 1 and 6 months after patient's death, if patient dies within 18 months of follow-up period of the study
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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
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1 and 6 months after patient's death, if patient dies within 18 months of follow-up period of the study
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christoffer Johansen, Professor, Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Myelodysplastic Syndromes
- Multiple Myeloma
- Death
- Hematologic Diseases
Other Study ID Numbers
- P-2022-93
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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