Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 920
- 试验地点
- 14
- 主要终点
- Change from baseline through 3,6,9,12 and 18 months follow-up in patient's anxiety symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
研究组 & 干预措施
control
Participants will receive no intervention only usual care.
ACT intervention
Participants will receive the ACT intervention
干预措施: Advance consultation concerning your life and treatment (ACT ) (Behavioral)
结局指标
主要结局
Change from baseline through 3,6,9,12 and 18 months follow-up in patient's anxiety symptoms
时间窗: 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.
Change from baseline through 3,6,9,12 and 18 months follow-up in caregiver's anxiety symptoms
时间窗: 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.
Use of chemotherapy within the last 30 days of life.
时间窗: 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
次要结局
- Change from baseline through 3,6,9,12 and 18 months follow-up in caregivers' depressive symptoms(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 Satisfaction with intervention sessions(7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group)
- Bereaved caregivers' anxiety symptoms(1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study)
- Self-efficacy - advance care planning(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.)
- Survival(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 social support(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(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 patients with referral to hospice in the last 30 days of life(30 days prior to date of death, if patient dies within 18 months of follow-up period of the study)
- Number of Days of hospitalized in the last 30 days of life(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(30 days prior to date of death,if patient dies within 18 months of follow-up period of the study)
- Burnout(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(After completion of 5 ACT-intervention sessions (intervention group) through study completion, an average of 1 year,)
- Change from baseline through 3,6,9,12 and 18 months follow-up in patient's prognostic understanding(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 social support(baseline, 3,6,9,12, and 18 months of follow-up. investigator will use mixed effects models to utilize the repeated mea)
- Patient satisfaction with intervention sessions(7 days after each ACT intervention session through the study until 8 months of follow-up for intervention group)
- Post-traumatic stress(1 and 6 months after patient's 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 quality of life(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(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 relationship 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 caregiver's relationship 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 caregiver's satisfaction with health care(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(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.)
- Bereaved caregivers' depressive symptoms(1 and 6 months after patient's death, if the patient dies within 18 months follow-up period of the study.)
- Prolonged Grief(six months after patient's death, if patient dies within 18 months of follow-up period of the study)
- Existential communication(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.)
- Perception of the patient's quality of death(One months after patient's death, if patient dies within 18 months of follow-up period of the study)
研究者
Christoffer Johansen
Professor MD, PhD, DMsc (Med)
Rigshospitalet, Denmark