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NCT01955395 · ClinicalTrials.gov registry record · NA
Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma
A NA study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- NA
- Development phase
- 93
- Enrollment target
NCT01955395: Completed NA study, sponsored by Dana-Farber Cancer Institute.
NCT01955395 is a NA study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 93 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01955395, a NA study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- NA
- Development phase
- 93 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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).
Interventions
- BEHAVIORAL Relaxation Response Resiliency Program (3RP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2013-10 |
| Est. Completion | 2016-09 |
| Phase | NA |
What the finished NCT01955395 record still lists
NCT01955395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Relaxation Response Resiliency Program (3RP) is the first listed.
NCT01955395 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01955395 about?
NCT01955395 is a clinical study titled "Genomic and Psychosocial Effects of the 3RP on Patients With MGUS and Smoldering Multiple Myeloma". 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 res...
What is the current status of trial NCT01955395?
This trial is currently completed. It is a NA study. The enrollment target is 93 participants. The study started on 2013-10. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01955395?
The interventions under investigation include: Relaxation Response Resiliency Program (3RP) (BEHAVIORAL).
Who is sponsoring clinical trial NCT01955395?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01955395's enrollment target sits among peer trials
93 937th of 2000 higher than 1,064 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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