Explore our Areas of Research

Behavioral Health and Self-care Projects

Randomized Study of a Psychological Intervention Mobile Application to Promote Coping in Patients with Acute Myeloid Leukemia (NAVIGATE)

Principle Investigator: Areej El-Jawahri, MD
Funding Source: National Palliative Care Research Center
Dreamland logoNAVIGATE is a Randomized Study of a Psychological Intervention Mobile Application (app) “DreAMLand” to Promote Coping in Patients with Acute Myeloid Leukemia (AML). This study assesses the feasibility and preliminary efficacy of the DreAMLand app for patients with a new diagnosis of AML, aiming to assess the ability of the app to help patients cope and provide pertinent information about their diagnosis amid their new hospitalization.

Quality of Life and Psychological Distress in Patients with Multiple Myeloma and their Caregivers (MM QOL)

Principle Investigator: Elizabeth K. O’Donnell, MD
Funding Source: Kully Family Foundation
Description: MM QOL is a multi-center study that aims to assess changes in quality of life, psychological distress, and prognostic understanding among multiple myeloma patients receiving treatment as well as their caregivers. Previous research has found that multiple myeloma patients have lower health-related quality of life compared to other cancer survivors. This study examines the emotional and physical effects of a multiple myeloma diagnosis and associated therapies among 180 patients and 180 caregivers. The principal investigator for this study is Dr. Elizabeth K. O’Donnell, with Dr. Areej El-Jawahri serving as a sub-investigator at Massachusetts General Hospital. Dr. Omar Nadeem is the site principal investigator at Dana-Farber Cancer Institute.

Screen Aiding Screening Support In Stopping Tobacco (Screen ASSIST)

Principle Investigator(s): Elyse Park, PhD, MPH Jennifer Haas, MD, Nancy Rigotti, MD
Funding Source: National Institutes of Health, R01
Description: Screen ASSIST is a randomized factorial design trial that tests the effectiveness of three evidence-based tobacco treatment modalities (4 vs. 8 counseling sessions, 2 vs. 8 weeks of NRT, and referral/non-referral to a community resource) among current smokers undergoing lung cancer screening. The study will evaluate the reach, adoption and implementation of the trial across 7 lung cancer screening sites within Mass General Brigham Healthcare System. The trial began enrolling patients in April 2019 and aims to accrue 720 patients.

Caregiver Projects

NeuroCARE: A Psychological Intervention for Caregivers of Patients with Malignant Gliomas (RCT)

Principal Investigator: Deborah Forst, MD
Funding Source: Conquer Cancer, The ASCO Foundation
Description: NeuroCARE is a single-site randomized controlled trial assessing the efficacy of a caregiver-directed intervention designed to improve anxiety in caregivers of patients with malignant gliomas, in comparison with caregivers who receive usual care. This supportive videoconference-based psychosocial intervention aims to reduce psychological distress and anxiety and improve caregivers’ quality of life through coping strategies and mindfulness exercises.

Communication and Decision-Making Projects

A Study of Patient and Caregiver Understanding of Cancer Immunotherapy Risks, Benefits, and Goals (IO)

Principal Investigator: Laura Petrillo, MD
Funding Source: N/A
Description: IO is a mixed methods study to elucidate how patients with metastatic melanoma or non-small cell lung cancer (NSCLC), their caregivers, and oncology clinicians currently communicate about the risks, benefits, and goals of treatment with immunotherapy, and understand what makes such communication challenging from the perspective of patients, caregivers, and oncology clinicians. Immunotherapy, specifically a class of drugs called immune checkpoint inhibitors, has demonstrated impressive survival benefits in both of these diseases for a minority of patients who receive them. However, the range of possible outcomes with immunotherapy makes understanding the goal of treatment difficult for patients, especially given the potential for indefinite, long-term responses. This study will inform the development of a supportive care intervention tailored to patients with metastatic melanoma or NSCLC and their caregivers.

Exploring Clinician, Patient, and Caregiver Perceptions of Factors Relevant for Discharge Decision-Making (TRANSITIONS)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: Internal Funding
Description: TRANSITIONS is a 45-participant qualitative study that addresses a gap in the literature about discharge decision-making and posthospital transitions of care among older adults with advanced cancer. The goal of the study is to identify components of the discharge decision-making process for patients hospitalized with advanced cancer in order to inform future interventions to improve their quality of end-of-life care and reduce burdensome transitions of care at the end-of-life. We aim to 1) explore clinicians’ perceptions of the factors relevant to making discharge decisions for hospitalized patients with advanced cancer, 2) explore patients’ and caregivers’ perceptions of the factors relevant to making discharge decisions; and 3) assess patients’ and caregivers’ perceptions of post-discharge care after hospitalization.

Geriatric Projects

A Geriatric Oncology Collaborative Care Intervention for Older Adults with Advanced Cancer (K12)

Principal Investigator: Ryan Nipp, MD, MPH
Funding Source: National Institutes of Health
Description: Cancer disproportionately affects older adults, and older adults with advanced cancer often possess a distinct set of medical and psychosocial issues that makes caring for the geriatric oncology population challenging. Due to the existence of a critical knowledge gap regarding how to best deliver comprehensive cancer care targeting the unique geriatric and palliative care needs of these individuals, this study proposes the creation of a geriatric oncology collaborative care intervention to improve supportive care outcomes for older adults with advanced cancer. The intervention will entail visits with a specially trained clinician in the cancer center to address patients' unique needs, who will meet regularly with a supervising team of geriatric, palliative care, social work, and pharmacy clinicians for feedback and iterative reevaluation of the care plan.

Health Disparities and Inequities Projects

BRIDGE: Proactive Psychiatry Consultation and Case Management for Patients with Cancer

Principal Investigator: Kelly Irwin, MD
Funding Source: National Cancer Institute
Description: The BRIDGE Trial: Proactive Psychiatry Consultation and Case Management for Patients with Cancer is a randomized controlled trial assessing the impact of proactive psychiatry consultation and person-centered collaborative case management for patients who have both a serious mental illness and a recent cancer diagnosis. The trial examines the impact of proactive psychiatric consultations and social work consultations on cancer care, as well as on patient and caregiver-reported outcomes. BRIDGE also aims to determine and address barriers and facilitators to implementing and disseminating a proactive psychiatry and social work intervention. To learn more, please email the study contact, Maura Barry.

Clinical Trials page

Palliative Care Projects

A Longitudinal Study of Quality of Life and Psychological Distress in Patients Receiving CAR T Therapy and their Caregivers (CAR-T PRO)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: Leukemia and Lymphoma Society
Description: CAR-T PRO is a Longitudinal Study of Quality of Life and Psychological Distress in Patients Receiving CAR T Therapy and Their Caregivers. This study examines the experience of CAR-T therapy on patients along with their prognostic understanding with receiving their CAR-T therapy. Since this is a new type of cancer therapy, our goal is to better understand this experience so that we may better assist them and their caregivers through this process in the future. This study also involves a neurocognitive assessment to better understand the potential cognitive effects of CAR-T over the course of their treatment. We have an accrual goal of 100 patients.

A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy (CREATE Video 19-790)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: Leukemia and Lymphoma Society
Description: CREATE is a Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy. This study is assessing the feasibility, efficacy, and acceptability of this educational video tool on these patients, and we are attempting to determine its impact on preferences and knowledge of CAR-T Therapy. We have an accrual goal of 60 patients.

The Prognostic Awareness Questionnaire: Scale Development and Evaluation (ENVISION 2.0)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: Internal Funding
Description: ENVISION 2.0 is a 600-patient cross-sectional study that seeks to refine and further develop an instrument to assess the multi-dimensional aspects of prognostic awareness. Our group has previously developed the Perception of Treatment and Prognosis Questionnaire (PTPQ) to assess patients’ overall perception of their prognosis and treatment goals. Studies utilizing the PTPQ have shown that patients with cancer have substantial misperceptions about their prognosis and overall goals of their treatment. However, we have noted important limitations of the PTPQ in assessing important domains of prognostic awareness including the cognitive acknowledgement of having a life limiting illness, how patients cope with their prognostic awareness, and their distress from prognostic uncertainty. The goal of this study is to conduct further scale development and evaluation of the PTPQ by testing its psychometric properties.

PALCare: Patient Reported Outcomes and Prognostic Understanding in Patients with End-Stage Liver Disease (PALCare)

Principal Investigator: Nneka N. Ufere, MD
Funding Source: GI Innovations Award
Description: PALCare is a prospective longitudinal survey study of patients with end-stage liver disease (ESLD) and their caregivers to generate a comprehensive assessment of their experiences. This study aims to assess the quality of life, symptom burden, and perception of illness and prognosis for patients with ESLD as well as assessing the quality of care received by these patients at end of life. Additionally, the study aims to assess the burden and distress for caregivers of patients with end-stage liver disease. The results of this project will be used to develop palliative care interventions that address the specific needs of ESLD patients and their caregivers over the course of their illness trajectory both pre- and post-transplant and at end of life."

Multi-Site Randomized Trial of Inpatient Palliative Care for Patients with Hematologic Malignancies Undergoing Hematopoietic Stem Cell Transplantation (PROTECT)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: Internal Funding
ProtectDescription: PROTECT is a multisite, randomized control trial of inpatient palliative care integrated with transplant care versus transplant care alone in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation. The primary goal of this study is to test the efficacy of inpatient palliative care integrated with transplant care for improving patient-and caregiver-reported outcomes. Additionally, we will assess participants’ long-term quality of life and psychological outcomes. There are three sites participating in the study – MGH, Duke Cancer Center, and Fred Hutchinson Cancer Center.

Comparative Effectiveness of Early Integrated Telehealth versus In-Person Palliative Care for Patients with Advanced Lung Cancer (REACH PC)

Principal Investigators: Jennifer Temel, MD and Joseph Greer, PhD
Funding Source: Patient-Centered Outcomes Research Institute
Description: REACH PC is a multisite study of 1250 patients that compares the effectiveness of early integrated palliative care versus in-person palliative care for patients with advanced lung cancer. Early and longitudinal involvement of palliative care in the outpatient management of patients with advanced cancer has been shown to improve patient-reported and end-of-life care outcomes. Many cancer care settings, however, have insufficient outpatient palliative care services and patients who receive care in remote, resource-poor, and rural settings may have no access to these services. By using secure video-conferencing technology, it is possible to overcome these barriers and increase patients' access to palliative care services in a patient-centered manner. The primary goal of this study is to determine if telehealth palliative care is just as effective as in-person palliative care for improving quality of life, mood, symptoms, and satisfaction with care for patients with advanced lung cancer and their caregivers.

Randomized Trial of a Collaborative Palliative and Leukemia Care Model for Patients with Acute Myeloid Leukemia and myelodysplastic syndrome Receiving Non-Intensive Therapy (SPRINT)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: Massachusetts General Hospital Executive Committee on Research
Description: SPRINT is a multi-site randomized controlled trial of collaborative palliative and leukemia care versus standard leukemia care alone in patients with AML and high-risk MDS receiving non-intensive chemotherapy. The intervention entails longitudinal inpatient and outpatient palliative care visits for this population focusing on symptom management, illness understanding, treatment decision-making, EOL care planning, and patients’ coping. This research will benefit the field of oncology by demonstrating improvements in the quality of care and resource utilization through timely integration of palliative care for patients with AML and high-risk MDS receiving palliative chemotherapy. 

Randomized Trial of Stepped Palliative Care versus Early Integrated Palliative Care in Patients with Advanced Lung Cancer (STEP PC)

Principal Investigator: Jennifer Temel, MD
Funding Source: National Institutes of Health (R01 CA215188)
Description: STEP is a randomized controlled trial designed to determine whether a stepped palliative care model is non-inferior to an early integrated palliative care model for patients with advanced lung cancer. In the stepped care group, patients meet with a palliative care clinician only at clinically relevant times, unless their quality of life worsens a great deal and then they “step up” to monthly visits. Patients assigned to the early integrated palliative care intervention maintain monthly visits with a palliative care clinician. The primary outcome is patient-reported quality of life, and secondary outcomes include quality of end of life care, palliative care resource utilization, and cost-effectiveness.

Quality Improvement Projects

Cancer and Mental Health Collaborative (Engage Initiative)

Principal Investigator: Kelly Irwin, MD
Funding Source: Patient-Centered Outcomes Research Institute
Description: The Engage Initiative is a coalition dedicated to ensuring that mental illness is never a barrier to cancer care or research. Through advocacy, person-centered research, education, and clinical innovation, we aim to close the cancer mortality gap experienced by individuals affected by mental illness. We partner in this work with the Massachusetts Department of Mental Health, the National Alliance on Mental Illness - Massachusetts, and North Suffolk Mental Health, among others. The Engage Initiative is guided by a community stakeholder board which includes individuals affected by mental illness and cancer, clinicians, advocates, and researchers. We are committed to anti-racist action and to advancing equity in care and research for all people affected by mental illness and cancer. We host the annual Bridging the Divide Symposium and other virtual events.

Learn more and join us at Engage Initiative

Trefler Virtual Equity Hub

Principal Investigator: Kelly Irwin, MD
Funding Source: Trefler Foundation
Description: The Trefler Virtual Equity Hub for Cancer Treatment is a program that utilizes telehealth technology to link community-based clinicians to specialty care teams at the Cancer Center who provide personalized, multi-disciplinary guidance for the initial treatment of breast and colorectal cancer and address barriers to care via virtual equity tumor boards. The goal of this project is to provide timely, cutting-edge, person-centered care to all people at risk for or diagnosed with cancer by holding monthly virtual tumor boards with Boston Medical Center and Massachusetts General Hospital North Shore.

Survivorship

Bounce Back: A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors

Principal Investigator: Giselle Perez, PhD
Funding Source: National Cancer Institute
Description: Bounce Back is a pilot randomized control trial examining the preliminary feasibility and acceptability of a virtual group stress management and resiliency program for adolescent and young adult (AYA) cancer survivors. The program consists of eight 90-minute sessions led by an experienced MGH clinician during which participants will learn tailored stress management skills and discuss survivor-specific topics (i.e. exercise, healthy eating). Survivors will be eligible if they 1) are between the ages of 16-29, 2) were diagnosed with cancer between the ages of 14-29, and 3) completed cancer treatment within the last 5 years. 

Interested participants can sign up for the study and learn more information here

Pilot Study to Assess Prolonged Nightly Fasting in Breast Cancer Survivors (Fasting Study)

Principle Investigator: Elizabeth K. O’Donnell, MD
Funding Source: Kully Family Foundation
Description: Fasting Study is a pilot study evaluating the feasibility of a 12-week prolonged nightly fasting intervention in breast cancer survivors. Effects on body size, blood biomarkers, quality of life, emotional regulation, fatigue, and levels of physical activity will be assessed. Drs. Jeffrey Peppercorn and Amy Comander serve as the sub-investigators at Massachusetts General Hospital.

A Pilot Study to Assess the Haymakers for Hope Fitness Program in Cancer Survivors (Haymakers for Hope)

Principle Investigator: Elizabeth K. O’Donnell, MD
Funding Source: Haymakers for Hope
Description: Haymakers for Hope is a pilot study examining the feasibility of a 16-week boxing-based fitness program for cancer survivors sponsored by Haymakers for Hope (H4H), a non-profit organization that raises money for cancer through charity boxing events. Participants attend weekly supervised sessions comprising strength, flexibility, and balance exercises. This intervention aims to improve cardiopulmonary fitness, muscle strength, body composition, quality of life, fatigue, and mood. 

Understanding and Improving Health Insurance Coverage among Long-Term Follow-up Study Cohort Participants (HINT)

Principle Investigator(s): Elyse Park, PhD, MPH
Funding Source: American Cancer Society
Description: The HINT (Health Insurance Navigation Tools) study seeks to develop a health insurance navigation program for survivors of childhood cancer. The present study proposes a health insurance navigation program to assist childhood survivors in understanding and utilizing their health insurance in a positive manner. The proposed navigation intervention will include 4 weekly videoconferencing-based sessions with a health insurance navigator on the following domains: 1. Learning Abut Survivorship Healthcare Needs; 2. Learning About Your Plan in Relation to Policy; 3. Navigating One's Own Plan and Overcoming Obstacles; 4. Managing Care Costs. This study aims to develop a psychoeducational health insurance navigation program (HINP), to conduct a videoconferencing-based pilot randomized trial of the HINP (n= approximately 80), and to refine the HINP program for future use. 

Randomized Trial of a Multimodal Sexual Dysfunction Intervention for Hematopoietic Stem Cell Transplant Survivors (SPARK)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: American Cancer Society, Research Scholar Grant
Description: SPARK is a randomized trial assessing the effectiveness of multimodal sexual health consults for hematopoietic stem cell transplant (HCT) survivors experiencing disruption in sexual health or intimacy following transplant. Despite the prevalence of sexual dysfunction in HCT survivors, interventions to improve sexual function are lacking, creating a critical need for comprehensive intervention. The study aims to evaluate the efficacy of clinician consult in improving patient-reported sexual function. We additionally aim to assess the impact of the intervention on patient-reported quality of life and psychological outcomes. We hope data from this project will lay the foundation for a future multi-site trial to enhance sexual function and survivorship care for HCT survivors. 

Multimodal Mobile Intervention Application (app) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors (SHIFT)

Principal Investigator: Areej El-Jawahri, MD
Funding Source: National Institute of Nursing Research
Description: SHIFT is a randomized trial assessing the effectiveness of an intervention aiming to improve sexual dysfunction in hematopoietic stem cell transplant (HCT) survivors. Despite the high prevalence of sexual dysfunction in HCT survivors, there are currently no interventions to address the disruptions in sexual health affecting this population. Additionally, to our knowledge no studies exist regarding the efficacy of a mobile app to specifically address sexual dysfunction. The goal of this study is to develop, refine, and test a self-administered, mobile sexual dysfunction intervention application (app). In addition to assessing the feasibility of the intervention in addressing sexual dysfunction in HCT survivors, we additionally plan to determine the preliminary efficacy of the intervention in improving patient-reported sexual function, quality of life, and psychological outcomes.

Implementing a Virtual Tobacco Treatment for Cancer Patients in Community Oncology Practices “Smoke Free Support Study 2.0” (SSS 2.0)

Principle Investigator: Elyse Park, PhD, MPH
Funding Source: National Institutes of Health, Sponsor: ECOG-ACRIN Cancer Research Group, Collaborator: National Cancer Institute (NCI)
Description: The Smoke Free Support Study 2.0 examines the effectiveness and implementation of a virtually delivered evidence-based tobacco treatment at community-based cancer centers (NCORP). This phase II trial studies how well smoking cessation treatment plans work in tobacco-dependent cancer patients in community oncology practices when delivered virtually as a part of their cancer care. Providing virtual information and counseling sessions may help cancer patients quit smoking. The study aims include assessing treatment effectiveness by comparing participants assigned to Enhanced Usual Care (EUC) and Virtual Tobacco Treatment (VIT) study arms abstinence post enrollment, assessing the potential effect of moderators (e.g. sociodemographic, medical and smoking history, cancer variables) on treatment effectiveness between the two arms, and assessing the processes of implementation and dissemination (acceptability, adoption, appropriateness, treatment fidelity, cost effectiveness, penetration/reach, and sustainability) of delivering these interventions at community oncology sites.

The Transitions Project: Supporting Adults During the Shift from Cancer Treatment to Surveillance

Principle Investigator: Lara Traeger, PhD
Funding Source: Internal Funding and Support from the Phyllis & Jerome Lyle Rappaport Foundation
Description: The Transitions Project is a feasibility randomized clinical trial testing whether the program is feasible and acceptable to patients. As patients with thoracic cancers complete treatment with curative intent, they may face heightened uncertainty about the future or other stressors during their shift to follow-up care. We have developed a supportive care program to help patients learn and practice specific skills for maintaining quality of life during this unique transition. We also will explore how the program may help patients improve different aspects of their quality of life. Findings from this study will help us to enhance the standard of care for patients with thoracic cancers.

Symptom Management Projects

Brief Behavioral Intervention for Dyspnea in Patients with Advanced Lung Cancer (BREEZE)

Principle Investigator(s): Joseph Greer, PhD and Jennifer Temel, MD
Funding Source: National Institutes of Health (R01 NR016694)
Description: BREEZE is a randomized controlled trial designed to test the efficacy of a two-session behavioral intervention for improving self-reported dyspnea in patients with advanced lung cancer. This nurse-delivered intervention aims to improve patients’ dyspnea, quality of life, psychological distress, and activity level through psychoeducation, relaxation training, and behavioral symptom management techniques. The principal investigators for this study are Drs. Joseph Greer and Jennifer Temel at Massachusetts General Hospital, with Dr. Mary Cooley serving as the site principal investigator at Dana-Farber Cancer Institute.

Feasibility of Integrating the Outcomes4Me Smartphone Navigation Application into the Care Management of Breast Cancer Patients (FIONA)

Principle Investigator: Jeffrey Peppercorn, MD, MPH
Funding Source: Outcomes4Me, Inc.
Description: FIONA is a single-arm pilot study of a breast cancer management smartphone app that is intended to assist patients in understanding their diagnosis and treatment options and managing their care, through symptom tracking and disease-directed information and resources. The purpose of this study is to understand how the Outcomes4Me app could be used to provide personalized support and care management for patients. This study aims to assess the feasibility of introducing use of the Outcomes4Me app within the standard care experience of breast cancer patients; evaluate the usability, satisfaction, and engagement of the app among patients.

Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) among Breast Cancer Survivors: A pilot feasibility trial

Principle Investigator: Jamie Jacobs, PhD
Funding Source: National Cancer Institute
Description: STRIDE is a randomized control trial examining the feasibility and acceptability of a small-group, videoconference intervention to optimize AET adherence, improve symptom management, and reduce distress for women taking adjuvant endocrine therapy (AET) after treatment for early stage, hormone receptor positive breast cancer. The primary objective of the current randomized controlled trial is to examine the feasibility and acceptability of the program. The secondary objectives are to examine changes in medication adherence, symptom distress, and overall satisfaction with AET. Findings from this study may inform survivorship care and inform next steps for improving clinical and psychological outcomes for patients taking AET. 

Supportive Oncology Care at Home for Patients With Pancreatic Cancer Receiving Preoperative FOLFIRINOX (SU2C-Medically Home Study)

Principal Investigator: Ryan Nipp, MD, MPH
Funding Source: Stand Up to Cancer; Dana Farber/Harvard Cancer Center
Description: Patients receiving preoperative FOLFIRINOX often experience numerous symptoms and side effects. Frequently, these patients require hospital admissions to help address uncontrolled symptoms related to their cancer and treatment. Medically Home interventions, which entail providing medical care to patients in their homes, may provide a solution. Additionally, previous research has demonstrated that symptom monitoring interventions can enhance patient outcomes. Thus, the goal of this study is to evaluate the feasibility and acceptability of an intervention, which we call "Supportive Oncology Care at Home," that entails both remote patient monitoring (e.g. symptoms, vital signs, and body weight) and a Medically Home care model (e.g. algorithms for phone calls and visits to patients' homes to address and manage any concerning issues identified). To accomplish this, we are conducting a single-arm pilot study in patients with pancreatic cancer receiving neoadjuvant FOLFIRINOX.