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

Multiple Myeloma Clinical Trial

— PEACE  

Official title:

Defining the Role of Palliative carE for Patients With Hematologic Malignancies Undergoing Adoptive CEllular Therapy: The PEACE Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646576
• Other study ID #: 22-487
• Status: Recruiting
• Phase: N/A
• Start date: December 30, 2022
• Est. completion date: April 1, 2027

Study information

• Verified date: May 2024
• Source: Massachusetts General Hospital
• Contact: Patrick C Johnson
• Phone: 617-724-4000
• Email: PCJOHNSON[@]MGH.HARVARD.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a single-center, parallel-group, randomized controlled study 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).

10 participants with planned ACT will be enrolled into an open pilot and will receive a palliative care intervention (PEACE) for the duration of treatment. Once the palliative care intervention has been refined by feedback from the pilot participants, the study will enroll 80 participants and will randomly assign the participants into one of two study intervention groups. Randomization means that a participant is put into a group by chance.

The names of the study intervention groups involved in this study are:

• Palliative care intervention (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.

The American Society of Clinical Oncology is supporting this research study by providing funding support.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 1, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment.

• Already receiving palliative care (PC).

Related Conditions & MeSH terms

• Blood Cancer
• Hematologic Malignancy
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Multiple Myeloma
• Neoplasms

Intervention

Behavioral:
• Palliative Care
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
Standard care for ACT per the treating team.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Conquer Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	Acceptability	Defined as at least 80% of participants reporting satisfaction with PEACE on an adapted version of the Client Satisfaction Questionnaire with scores >=20.	Up to Day 90
Secondary	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.	Baseline to day 90
Secondary	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)	Baseline to day 90
Secondary	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)	Baseline to day 90
Secondary	Post-Traumatic Stress Disorder (PTSD) Symptoms	Defined by Post-Traumatic Stress Disorder Checklist (PCL), comprised of 17 items that corresponds to key symptoms of PTSD.	Baseline to day 90
Secondary	Physical Symptom Burden	Defined by Edmonton Symptom Assessment (ESAS-R), which is a 10-item measure to assess symptoms relevant to patients undergoing adoptive cellular therapy	Baseline to day 90
Secondary	Coping	Defined by Brief COPE which is comprised of 14 items that assesses the degree to which a participant utilizes specific coping strategies.	Baseline to day 90
Secondary	Prognostic Understanding	Defined by Perception of Treatment and Prognosis (PTPQ), a survey that assesses participant understanding of illness and prognosis.	Baseline to day 90
Secondary	End-of-Life Communication	Defined by PTPQ, a survey that assesses participant understanding of illness and prognosis and includes an item on patient-reported end-of-life communication.	Baseline to day 90