Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma

Официальное название

Phase II Feasibility Study of Early Palliative Care for Patients With Multiple Myeloma and Aggressive Lymphoma

Обзор

Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis. Meanwhile, patients with aggressive lymphomas undergo unpredictable illness courses, resulting in goals of care conversations occurring late in the illness trajectory and aggressive care being received in the last 30 days of life. Early palliative care alongside usual cancer care has been shown to improve patient outcomes such as symptom burden, mood, and quality of life in patients with solid tumours (e.g. lung, breast or gynecological cancers), but has not been explored among patients with blood cancers to date. The goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) attending the Princess Margaret Cancer Centre. The main goals of the study are: * To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only) * To see if this early palliative care intervention works well for these patients and caregivers * To compare patient and caregiver experiences with early palliative care and usual care * To explore perceptions and experiences of providing palliative care among healthcare providers involved in the care of these patients and caregivers. Patients, and their respective caregivers if participating, will be randomly assigned to one of two groups: one group will receive early palliative care in addition to usual care from their blood cancer doctor, and the other group will receive usual care from their blood cancer doctor only. All participants will be asked to fill out questionnaires about their quality of life, symptom burden, mood, and satisfaction with care throughout the study. Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care and their caregivers. Some patients and caregivers will be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study. Some healthcare providers who care for these patients will also be asked to take part in interviews at the end of the trial to describe their perceptions and experiences of providing palliative care. The researchers will use the results of this study to guide in the development of a larger clinical trial.

Подробное описание

In this study, the investigators will test an early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma and their caregivers (lymphoma only) in a randomized phase II trial in which outpatients and their caregivers will be allocated to one of two groups: symptom screening alone (usual care) or early palliative care alongside usual care (intervention).

Participants will be recruited from multiple myeloma and lymphoma outpatient clinics at the Princess Margaret Cancer Centre. Consenting patients and caregivers will complete questionnaires measuring outcomes of quality of life, symptom burden, depression, and satisfaction with care at recruitment, 1 month, 2 months, and 3 months. After the 3-month follow-up time point, select patients and caregivers will complete a one-time semi-structured interview that explores their experiences taking part in the study. Select healthcare providers from the multiple myeloma, lymphoma, and palliative care teams will also be invited to participate in a one-time focus group or individual interview. Healthcare providers in malignant hematology will be asked to describe their perceptions of palliative care and providers in palliative care will be asked to describe their experiences providing palliative care to patients with multiple myeloma and aggressive lymphoma and their caregivers.

The purposes of this phase II trial are to:

1. Assess the feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only). 2. Assess preliminary efficacy of early palliative care for these outpatients and caregivers. 3. Qualitatively compare patient and caregiver experiences and perceptions of palliative care between the intervention and usual care arms of the study. 4. Qualitatively describe perceptions of palliative care among healthcare providers in malignant hematology, as well as the experiences of providing palliative care to patients with multiple myeloma and aggressive lymphoma among healthcare providers in palliative care.

Feasibility criteria are: (i) accrual of at least 80 patients (40 with multiple myeloma and 40 with aggressive B cell lymphoma) and up to 40 caregivers of patients with aggressive B cell lymphoma over 12 months; (ii) ≥60% of recruited patients and caregivers complete self-reported outcomes (PROs) at baseline, and monthly for three months; and (iii) ≥60% of patients and their caregivers in the intervention arm have at least one visit to the palliative care clinic.

Вмешательства

• Другое Early Palliative Care
  see previous description

Первичные конечные точки

• Feasibility of early palliative care for outpatients with multiple myeloma and aggressive lymphoma and their caregivers (lymphoma only) [Срок оценки: 12 months]
• Patient quality of life as measured by the FACIT-Pal [Срок оценки: 3 months after enrollment]

Вторичные конечные точки (7)

• Patient quality of life as measured by the FACIT-Pal [Срок оценки: 1 month and 2 months after enrollment]
• Patient symptom control as measured by the ESAS-r-CS [Срок оценки: 1 month, 2 months, and 3 months after enrollment]
• Patient and caregiver depression as measured by the PHQ-9 [Срок оценки: 1 month, 2 months, and 3 months after enrollment]
• Patient satisfaction with care as measured by the FAMCARE-P16 [Срок оценки: 1 month, 2 months, and 3 months after enrollment]
• Patient performance status as measured by the PRFS [Срок оценки: 1 month, 2 months, and 3 months after enrollment]
• Caregiver quality of life as measured by the CQOLC [Срок оценки: 1 month, 2 months, and 3 months after enrollment]
• Caregiver satisfaction with patient care as measured by the FAMCARE-caregiver [Срок оценки: 1 month, 2 months, and 3 months after enrollment]

Критерии участия

Patient eligibility criteria:

Критерии включения

(i) Age ≥18 years; (ii) A new diagnosis of multiple myeloma or at progression of disease necessitating a change in treatment plan, or relapsed/refractory aggressive B cell lymphoma after one prior line of therapy; (iii) Eastern Cooperative Oncology Group (ECOG) performance status 0-3; (iv) Willingness to complete symptom screening; and (v) At least one ESAS-r-plus symptom scored at ≥3 at time of recruitment.

Критерии исключения

(i) Insufficient English literacy to complete study procedures; (ii) Hematologist-determined poor cognitive status; (iii) Current palliative care team involvement at PM or elsewhere; and (iv) Not receiving ongoing follow up with malignant hematology team at PM.

Caregiver eligibility criteria:

Критерии включения

(i) Age ≥18 years; (ii) Caregiver of a patient with relapsed B cell lymphoma; and (iii) Willing to attend at least 1 PCC visit with the patient.

Критерии исключения

(i) Insufficient verbal and/or written English literacy to complete study procedures; or (ii) Patient not participating in study.

Healthcare provider eligibility criteria:

Критерии включения

(i) Specialized staff physician, fellow, clinical nurse specialist, or clinic nurse from the outpatient malignant hematology team or palliative care team at PM working clinically with patients with multiple myeloma; and (ii) Working in their clinical area for at least 12 months.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT06485076 · DeGasperis

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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