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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 is a NA study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 93 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01955395
The ClinicalTrials.gov registry entry for NCT01955395 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Relaxation Response Resiliency Program (3RP) is the first listed.
NCT01955395 reports 0 study locations.
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.
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