Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

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 volunteers

Qualifiers

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

Design model

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

    Behavioral

    Standard care for ACT per the treating team.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Palliative Care Intervention (PEACE) GroupExperimental treatment 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day

Secondary outcomes

1

Acceptability

Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores \>=20.

Time frame
Up to Day 90
2

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.

Time frame
Baseline to day 90
3

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)

Time frame
Baseline to day 90
4

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)

Time frame
Baseline to day 90

Other outcomes

Sponsors and contacts

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Massachusetts General Hospital

Lead sponsor

Conquer Cancer Foundation

Collaborator