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| Name | Class |
|---|---|
| Conquer Cancer Foundation | OTHER |
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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative Care Intervention (PEACE) Group | Experimental | Participants will be randomly assigned, and stratified by disease, to the PEACE Group.
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| Usual Care Group | Active Comparator | Participants will be randomly assigned, and stratified by disease, to the Usual Care Group and will receive standard care for ACT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palliative Care | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Quality of Life - FACT-G |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick C Johnson | Contact | 617-724-4000 | PCJOHNSON@MGH.HARVARD.EDU |
| Name | Affiliation | Role |
|---|---|---|
| Patrick C Johnson, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Cancer Center | Recruiting | Boston | Massachusetts | 02215 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation
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| Usual Care | Behavioral | Standard care for ACT per the treating team. |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Prognostic Understanding | Defined by Perception of Treatment and Prognosis (PTPQ), a survey that assesses participant understanding of illness and prognosis. | Baseline to day 90 |
| 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 |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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