About this trial
The goal of this study is to determine whether a palliative care intervention (PEACE) can improve the quality of life and experiences of participants with Lymphoma, Leukemia, or Multiple Myeloma receiving adoptive cellular therapy (ACT). After completion of an open pilot, participants will be randomly assigned into one of two study intervention groups.
The names of the study intervention groups involved in this study are:
* Palliative care (PEACE) plus usual oncology care * Usual care (standard oncology care)
Participation in this research study is expected to last for up to 2 years.
It is expected that about 90 people will take part in this research study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Ability to complete surveys in English or with assistance of an interpreter.
Diagnosis of a hematologic malignancy.
Receiving autologous adoptive cellular therapy (ACT) at MGH with an FDA approved cellular therapy product.
Disqualifiers
Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment.
Already receiving palliative care (PC).
Trial design
Parallel
Treatments tested in this trial
Palliative Care
Behavioral* Palliative care (PC) intervention tailored to ACT recipients and addressing multiple PC domains with the input of ACT clinical experts, PC clinicians, and patients and caregivers. * Domains discussed include therapeutic relationship, symptom management, prognostic awareness and illness understanding, coping with illness, treatment decision-making, EOL care. * The palliative care intervention will be refined for the randomized control trial based on the feedback from the open pilot.
Usual Care
BehavioralStandard care for ACT per the treating team.
Treatment groups
Trial outcomes
Primary outcomes
Percentage of Eligible Participants Enrolled to Palliative Care Intervention (PEACE) (Feasibility)
Defined as at least 60% of eligible participants enrolling in the study, and among those enrolled and randomized to PEACE, 80% receiving PEACE as intended.
Secondary outcomes
Acceptability
Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores \>=20.
Quality of Life - FACT-G
Defined by Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item questionnaire that assesses cancer domains of physical well-being, social/family well-being, and emotional and functional well-being.
Anxiety Symptoms
Assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), which is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)
Depression Symptoms
Assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), which is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress)
Sponsors and contacts
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Massachusetts General Hospital
Lead sponsor
Conquer Cancer Foundation
Collaborator