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This research study is evaluating the effects of a mind body medicine intervention called the Relaxation Response Resiliency Program (3RP) on stress and stress related symptoms in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM).
This research study is a supportive care trial. This means that the intervention program may improve general well-being and comfort, but is not considered a treatment or "cure" for MGUS or SMM. It is considered an investigational intervention because the investigators are examining the effectiveness of a new program - the 3RP - on reducing stress and stress-related symptoms in patients with MGUS and SMM. Standard management of MGUS and SMM involves regular monitoring without chemotherapy. Mind-body medicine, as defined by the National Institutes of Health, "focuses on the interactions among the brain, mind, body, and behavior, and on the powerful ways in which emotional, mental, social, spiritual, and behavioral factors can directly affect health." The 3RP is a newly designed group therapy program that through a variety of mind body principles and self-care interventions seeks to buffer stress and promote psychological resiliency and physical well-being.
This study will examine the effectiveness of the 3RP in reducing stress and symptoms associated with stress in patients diagnosed with MGUS or SMM. Data from this study will also be used to assess changes in gene expression that result from 3RP intervention, particularly genetic pathways that are known to be dysregulated in MM.
Before the research starts (screening): After signing this consent form, the participant will be asked some questions to find out if the participant can be in the research study:
- A medical history, which includes questions about the participant's physical and mental health, current medications, and any allergies.
If these tests show that the participant are eligible to participate in the research study, the participant will receive the study intervention. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
Research Study Plan:
Immediate Group
Waitlist Control
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Group | Active Comparator | If the participant is assigned to the Immediate Group, the participant will immediately receive the Relaxation Response Resiliency Program (3RP) intervention (3 months), followed by 3 months of continuing to practice what the participant learned during the intervention. |
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| Waitlist Group | Active Comparator | If the participant is assigned to the Waitlist Group, the participant will wait for 3 months and then receive the full Relaxation Response Resiliency Program (3RP) intervention (3 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxation Response Resiliency Program (3RP) | Behavioral | The intervention will consist of one intake with a psychologist (approximately 60 minutes), 8 3RP sessions once a week over the course of 8 weeks (approximately 1 hour and 30 minutes each), and one exit visit (approximately 30 minutes) over the course of 3-months. During the intervention, the participant will be asked to practice what the participant has learned in the intervention by listening to a 20-minute audio CD daily. Additionally, the participant will be asked to keep track of their daily practice by filling out an online or paper log. During the 3RP session, the clinician will address any barriers or problems the participant may be having with the daily practice and help to problem solve them with the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| NF-κB pathway expression in PBMCs | The expression of the NF-kB pathway in peripheral blood mononuclear cells will be determined on the basis of cumulative expression of normalized copy number of all the genes in the pathway. The genes for the NF-kB pathway will be obtained from the MSigDB (Molecule Signature Database) 3.0 (Broad Institute). | baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of the previously-defined RR-signature in PBMCs | The expression of previously-defined RR-signature in peripheral blood mononuclear cells (PBMCs) will be determined on the basis of cumulative expression of normalized copy number of all the genes in the signature. The genes for the signature are defined in Bhasin et al., PLoSOne, 2013. | baseline to 3 months |
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Inclusion Criteria:
MGUS
SMM (also referred to as asymptomatic multiple myeloma)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Denninger, MD/PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Dana Farber Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40681960 | Derived | Finkelstein-Fox L, Denninger JW, Walsh LE, Laubach JP, Yee AJ, O'Donnell E, Macklin EA, Gu X, Muzikansky A, Libermann TA, Nicolosi G, Richardson PG, Raje NS, Fricchione GL, Perez GK, Traeger LN, Chad-Friedman E, Park ER. Psychosocial and NF-kappaB Activity Effects of the Stress Management and Resiliency Training: Relaxation Response Resiliency Program (SMART-3RP) on Patients With MGUS and Smoldering Multiple Myeloma: A Randomized Waitlist Control Trial. Psychooncology. 2025 Jul;34(7):e70216. doi: 10.1002/pon.70216. |
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| Gene expression levels in PBMCs | Normalized gene expression levels in peripheral blood mononuclear cells using nanostring technology. | baseline to 3 months |
| PSS-10 score | Change in the 10-item perceived stress scale score. | baseline to 3 months |
| Normalized gene expression levels in clonal, CD138+ BMPCs | Normalized gene expression levels in clonal, CD138+ bone marrow plasma cells (BMPCs) measured using nanostring technology. | baseline to 3 months |
| Beck Anxiety Inventory score | Change in the Beck Anxiety Inventory score. | baseline to 3 months |
| Penn State Worry Questionnaire score | Change in the Penn State Worry Questionnaire score. | baseline to 3 months |
| LOT-R score | Change in the Life Orientation Test-Revised score. | baseline to 3 months |
| MOCS score | Change in the Measure of Current Status score. | baseline to 3 months |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02215 | United States |
| ID | Term |
|---|---|
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D006942 | Hypergammaglobulinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010265 | Paraproteinemias |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
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