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NCT Number: NCT05444348

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

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.

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Key information

Conditions

Multiple Myeloma Acute Myeloid Leukemia Blood Protein Disorders Bone Marrow Diseases Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg Universitetshospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advance consultation concerning your life and treatment (ACT )

Behavioral

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.

Primary outcomes

  1. 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

    Counts of patients receiving chemotherapy in the last 30 days of their life

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    Counts of days in hospital in the last 30 days of life of deceased patients

  2. 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

    Counts of medical consultation in the last 30 days of life of deceased patients

  3. 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

    Referral to hospice and days from referral to death

  4. Survival

    Time frame: days from diagnosis to death, if patient dies within 18 months follow-up period of the study

    Overall survival

  5. 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.

    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

  6. 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.

  7. 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.

    Caregiver reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.

  8. 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

    Patient reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"

  9. 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

    Caregiver reported outcome, questionnaire: Ways of providing support, 19-item, measure on a 5-point scale ranging from "never" to "very often"

  10. 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

    Patient reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality

  11. 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

    Caregiver reported outcome, questionnaire: Relationship ladder, single-item, measure on a scale from 0-10, with higher value as better quality

  12. 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.

    Patient reported outcome: Family Satisfaction With Advanced Cancer Care, measure on a 5-point scale where 1 is best and 5 is worst.

  13. 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.

    Caregiver reported outcome: Family Satisfaction With Advanced Cancer Care, measure on a 5-point scale where 1 is best and 5 is worst.

  14. 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.

    Patient reported outcome: Prognostic understanding, single item questionnaire

  15. 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.

    Caregiver reported outcome: Prognostic understanding, single item questionnaire

  16. 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

    Patient reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.

  17. 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

    Caregiver reported outcome: Satisfaction with intervention sessions, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.

  18. 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.

    Caregiver reported outcome of depression (patient Health Questionaires), reporting on a 4-point scale from 0-3 with high value as worse outcome.

  19. 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

    Caregiver reported outcome of anxiety (General anxiety disorder), reporting on a 4-point scale from 0-3 with high value as worse outcome.

  20. 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

    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

  21. 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

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

  22. Prolonged Grief

    Time frame: six months after patient's death, if patient dies within 18 months of follow-up period of the study

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

  23. 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.

    Clinician reported outcome: Advance care planning self-efficacy, 5 point scale from 1-5, higher score is better outcome

  24. 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.

    Clinician reported outcome: burnout (Copenhagen Burnout Inventory) 5-point scale, value 0-5, higher score means worse outcome

  25. 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.

    Clinician reported outcome: Existential communication, 5 point scale from 1-5, higher score is better outcome.

  26. Satisfaction with intervention

    Time frame: After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,

    Clinician reported outcome: satisfaction with intervention, questionnaire developed for the intervention, 5 point scale from 1-5, higher score is better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Annika von Heymann, PhD

CONTACT

[email protected]

+45 21310881

Cæcilie Borregaard Myrhøj, MScN

CONTACT

[email protected]

+45 60701620

Sponsors and collaborators

Lead sponsor

Christoffer Johansen

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Gødstrup Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark
  • Vejle Hospital
  • Zealand University Hospital

Registry information

Official study title

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

Acronym: ACT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2022
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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