Implementing a Virtual Tobacco Treatment in Community Oncology Practices: “Smoke Free Support Study 2.0”

Principal Investigator(s): Elyse Park, Ph.D; Jamie Ostroff, Ph.D.

Project Director: Brett Goshe, Ph.D.

Study Sites: NCI Community Oncology Research Program (NCORP) Community Sites and Minority/Underserved Community Sites

Study Coordinator: Autumn Rasmussen, B.A.

Funding Source: NIH, NCI

Study Description:

The Smoke Free Support Study 2.0, or SSS2, is designed to examine the effectiveness and implementation of a virtually-delivered, evidence-based tobacco treatment into cancer care for patients in community oncology settings. SSS2 is designed to compare the effectiveness and implementation of an Enhanced Usual Care (EUC; control group) versus a Virtual Intervention Treatment (VIT; intervention group) for tobacco cessation in newly diagnosed cancer patients who smoke. Trial findings will establish the effectiveness and cost of utilizing a virtual strategy to deliver evidence-based tobacco treatment in community oncology settings and provide detailed initial data on implementation processes that will inform subsequent testing of multi-level implementation strategies for broad national dissemination into community cancer care settings.


Organizational readiness and engagement of community oncology practices in implementing tobacco use assessment and treatment

Principal Investigator: Angela Wangari Walter, Ph.D, MP.H.

Project Director: Brett Goshe, Ph.D.

Study Sites: NCORP Community Sites and Minority/Underserved Community Sites

Study Coordinator: Autumn Rasmussen, B.A.

Funding Source: NCI

Study Description:

This diversity supplement enhances the clinical trial for the parent grant (R01CA214427; MPIs Drs. E. Park & J. Ostroff MPIs) by examining organizational contexts that influence adoption of tobacco use assessment and treatment interventions; and identifying strategies to facilitate implementation of evidence based tobacco treatment interventions in community cancer care settings.


Integrating Tobacco Treatment into Lung Screening at PHS / Screen ASSIST

Principal Investigator(s): Elyse Park, Ph.D. ; Nancy Rigotti, M.D. ; Jennifer Haas, M.D.

Study Sites: BWH Faulkner, MGH Chelsea, MGH Danvers, NWH Main, MGH Waltham, MGH Main: Yawkey 6, MGH Main: Blake 2; currently adding Martha’s Vineyard (MVH) and may add Cooley Dickinson

Study Coordinator(s): Caylin Marotta, B.A. ; Elise Noonan, B.A. ; Grace Styklunas, B.A. ; Cayley Bliss, B.A.

Funding Source: NIH / NCI RO1

Study Description:

The trial offers tobacco cessation treatment to smokers having a lung cancer screening test.  It is designed to help us meet the U.S. Preventive Services Task Force recommendation to offer smoking cessation as part of lung cancer screening. Screen ASSIST will identify current smokers who schedule a lung cancer screening test and offer them participation in a smoking cessation study. All study participants will receive evidence-based cessation treatment at no cost.  The goal is to identify the most effective combination of (1) tobacco cessation counseling (4 vs. 8 sessions); (2) nicotine replacement (2 vs. 8 weeks); and referral to a community-based resource to address social stresses that make quitting difficult (referral vs. no referral).  Smoking status (primary outcome) will be measured at 6-month follow-up.


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

Principal Investigator(s): Elyse Park, Ph.D. ; Giselle Perez Lougee Ph.D.

Patient Navigator: Allyson Foor

Study Sites: Affiliate St. Jude’s Cancer Research Center sites

Study Coordinator(s): Cayley Bliss, B.A.

Funding Source: American Cancer Society

Study Description:

Dr. Park and her colleagues published findings in the Journal of Clinical Oncology demonstrating that CCSS survivors, compared to siblings, were significantly more likely to be uninsured and to have difficulties obtaining health insurance. Given the current insurance landscape and the additional insurance burden that childhood cancer survivors face, the present study seeks to develop and pilot a health insurance navigation program targeted at feasibility and acceptability with survivors and improving health insurance literacy and ameliorating financial distress related to medical costs. The proposed health insurance navigation will involve 4 navigator-led health insurance navigation sessions. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.


Using a Virtual Health Insurance Navigation Pilot Program to Understand and Improve Health Insurance Coverage Among Survivors of Colorectal Cancer / HINT-C

Principal Investigator(s): Elyse Park, Ph.D. ; Giselle Perez Lougee Ph.D.

Patient Navigator: Allyson Foor

Study Sites: MGH

Study Coordinator(s): Cayley Bliss, B.A.

Funding Source: n/a

Study Description:

This trial aims to assess the feasibility and acceptability of colorectal survivors approached and engaged in HINT and aims to assess the preliminary efficacy of HINT to improve 1) health insurance literacy and 2) financial burden related to medical cost concerns colorectal survivors. The study investigators propose that, compared to the control arm (who will receive a health insurance information guide, but will not receive the navigation intervention), participants in the HINT intervention arm will have improved health insurance literacy and decreased financial distress related to medical costs.


Intervention for Fear of Cancer Recurrence and Uncertainty in Survivorship (IN FOCUS)

Principal Investigator: Daniel L. Hall, Ph.D.

Project Director: Emma Siefring, BA

Study Sites: MGH and BIDMC (DF/HCC)

Study Coordinator: Emma Siefring, B.A.

Funding Source: National Center for Complementary and Integrative Health K23At010157

Study Description:

This is a study to adapt and pilot test a virtual, multimodal mind-body resiliency intervention (SMART-3RP) to help cancer survivors manage fear of recurrence (FOR). FOR is a common, highly distressing difficulty after diagnosis of a chronic and/or life threatening illness that may increase risk for poorer clinical outcomes by influencing healthcare engagement (e.g., frequency of follow-up screening). Among cancer survivors, a population growing in prevalence, clinically-impairing FOR is pervasive and can persist for years. Using qualitative and quantitative methods, this project will assess the feasibility and acceptability of an adapted mind-body intervention targeting FOR among cancer survivors and will inform the science of managing these fears and their clinical consequences among medical populations more broadly. Phase 1 of this study included focus groups and individual interviews with cancer survivors to identify targets for adaptation, including FOR-related coping and healthcare engagement patterns. Phase 2 will test the feasibility of the adapted intervention in a pilot RCT and will explore preliminary effects on FOR and healthcare engagement outcomes.

Interested in participating? Email us at
FOCUS@mgh.harvard.edu or visit our recruitment website: https://rally.partners.org/study/infocus


Survivorship Sleep Program (SSP): An Adapted Telehealth Intervention for Insomnia among Cancer Survivors

Principal Investigator: Daniel L. Hall, Ph.D.

Study Sites: MGH (DF/HCC)

Study Coordinator: Emma Siefring, B.A.

Funding Source: American Cancer Society / MGH Institutional Research Grant

Study Description:

This is a study to test the feasibility, acceptability, and preliminary effects of a virtual cognitive behavioral therapy for insomnia (CBT-I) program for cancer survivors. Insomnia is a significant and often unaddressed problem for adults treated for various types of cancer, with a prevalence rate (30-50%) approximately three times as high as in the general population. CBT-I is a safe, highly effective, and affordable treatment for insomnia that may be delivered to patients in as few as four sessions; however, attrition is common, and engaging patients may require a patient-centered approach.
Using qualitative and quantitative methods, this project will seek to adapt CBT-I to address survivor late effects and unique sleep related concerns. Phase 1 of this study included 10 individual interviews with cancer survivors with insomnia to identify perceived needs and preferences for virtually-delivered CBT-I. Phase 2 is testing the feasibility and preliminary efficacy of the Survivorship Sleep Program in a pilot RCT and will explore preliminary effects on evening actigraphy measures. (NCT04566068)


Prevalence and Patterns of Vaping Nicotine and Cannabis by Patients with Opioid Use Disorder

Principal Investigator(s): Nancy Rigotti, M.D. ; Eden Evins, M.D.

Project Director: Joanna Streck (K12 Scholar)

Study Sites: MGH

Study Coordinator: Kelly Kalagher (Former CRC, Current Med Student)

Funding Source: NIDA K12 DA043490

Study Description:

Mixed-methods cross-sectional study to examine vaping and cigarette smoking behaviors, and corresponding risk perceptions, among adults with OUD who are treated with buprenorphine at MGH-affiliated community health centers.


Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors

Principal Investigator(s): Christina Luberto, Ph.D.

Study Sites: Mongan Institute

Study Coordinator: Maria Lopes, B.A.

Funding Source: NIH/NIA

Study Description:

Spontaneous coronary artery dissection (SCAD) is an important cause of cardiac events, primarily affecting young healthy women with no cardiovascular risk factors. The 10-year recurrence rate is 30%, but SCAD recurrence cannot be predicted. Approximately half of SCAD survivors struggle with significant anxiety and fear of recurrence (FOR), which contributes to poor sleep and physical inactivity and, thereby, increased risk of recurrence. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention with evidence to improve FOR and health behaviors (sleep, physical activity), through psychological mechanisms that directly target key FOR processes (interoceptive bias, intolerance of uncertainty). I adapted MBCT to target FOR, sleep, and physical activity in cardiac event survivors via group videoconferencing delivery (UpBeat-MBCT), however this intervention has not yet been targeted to SCAD survivors. I propose an open pilot trial to test the feasibility, acceptability, and changes in psychological and behavioral health variables in SCAD survivors participating in UpBeat-MBCT (N=16). Participants will be recruited from the MGH SCAD Program and asked to complete self-report surveys and actigraphy before and after the intervention. The primary outcomes are feasibility and acceptability of the intervention and research procedures. Exploratory outcomes are changes in psychological and behavioral variables and their inter-correlations. This project would be the first and only behavioral intervention for SCAD survivors and would provide preliminary data for an NIH Stage II efficacy trial to develop an accessible and efficacious intervention for a vulnerable group of SCAD survivors, with generalizability to survivors of other cardiac events.


Mindfulness-Based Cognitive Therapy Delivered via Group Videoconferencing for Acute Coronary Syndrome Patients with Depressive Symptoms

Principal Investigator(s): Christina Luberto, Ph.D.

Study Sites: Mongan Institute

Study Coordinator: Maria Lopes, B.A.

Funding Source: NIH/NCCIH

Study Description:

The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.


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

Principal Investigator(s): Kelly Irwin, M.D., M.P.H.

Project Director: Zoe Nelson, B.A.

Study Sites: MGH

Study Coordinator: Samar Shaqour, B.A.

Funding Source: NIH-NCI National Cancer Institute

Study Description:

Our overall goal in this program of research is to eliminate disparities in cancer mortality of patients with SMI. With this proposed single-site RCT, we will assess the preliminary efficacy of the PPC model and create an implementation strategy that can be tested in a larger scale, R01-funded trial to investigate the effectiveness of PPC in improving cancer care for patients with SMI and their caregivers.


Bridging the Virtual Divide during COVID19: Virtual Outreach Strategies

Principal Investigator(s): Kelly Irwin, M.D., M.P.H.

Project Director: Emily Gorton, M.P.H.

Study Sites: MGH

Study Coordinator: Samar Shaqour, B.A. ; Zoe Nelson, B.A.

Funding Source: PCORI

Study Description:

With this study, we aim to (1) identify barriers and facilitators to engagement and use of technology among vulnerable older adults with SMI, their caregivers, and clinicians during the COVID19 pandemic and (2) capture emerging research questions, create a shared agenda for patient-centered research, and co-design and disseminate a toolkit for virtual engagement for older adults with SMI.


Enhancing Resilience in Senior Living Community Residents

Principal Investigator(s): Lara Traeger, Ph.D.

Project Director(s): Lara Traeger, Ph.D.; Elyse Park, Ph.D.

Study Sites: Maryland, Massachusetts, Texas, Colorado

Study Coordinator: Grace Styklunas, B.A.

Funding Source: Erickson Senior Living

Study Description:

Feasibility pilot trial, implementing SMART-3RP program at four senior living communities.


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

Principal Investigator: Giselle Perez, Ph.D.

Study Sites: MGH

Study Coordinator: Emma Siefring, B.A.

Funding Source: NCI

Study Description:

Bounce Back is a pilot randomized waitlist-control trial of a highly-scalable virtual group program aimed at promoting stress management and coping among post-treatment adolescent and young adult cancer survivors. Bounce Back was adapted from an existing evidence-based resiliency program, the Stress Management And Relaxation Training Relaxation Response Resiliency Program.