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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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. T

Первичные конечные точки

• Use of chemotherapy within the last 30 days of life. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (12)

• Number of Days of hospitalized in the last 30 days of life [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 30 days prior to date of death, if patient dies within 18 months of follow-up period of the study]
• Survival [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Дания · 7 центров

• Aalborg Universitetshospital — Aalborg
• Aarhus Universitetshospital — Aarhus
• Sydvestjysk sygehus - Esbjerg — Esbjerg
• Regionshospitalet Gødstrup — Herning
• Odense Universitetshospital — Odense
• Sjællands universitetshospital Roskilde — Roskilde
• Lillebælt syge - Vejle Sygehus — Vejle

Публикации

• Borregaard Myrhoj C, Clemmensen SN, Jarden M, Johansen C, von Heymann A. Compassionate Communication and Advance Care Planning to improve End-of-life Care in Treatment of Haematological Disease 'ACT': Study Protocol for a Cluster-randomized trial. BMJ Open. 2024 May 21;14(5):e085163. doi: 10.1136/bmjopen-2024-085163. PMID 38772898

Идентификаторы

NCT: NCT05444348 · P-2022-93

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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