A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year.
Patients with a diagnosis of MGUS or SM who are willing and able to participate in this 12-month multimodal lifestyle approach. Eligible patients include those 18 years of age and older diagnosed with MGUS/SM, ECOG PS 0-2, absence of significant comorbidities, and ability to speak/read/understand English. The multimodal lifestyle intervention has six foci: Positive cognition \[mindset\], Exercise/movement, Stress Reduction, Social Connection, Emotional Wellbeing, and Nutrition. All programming will take place online to maximize convenience/sustained participation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
67
The multimodal lifestyle intervention has six foci: positive cognition, exercise/movement, stress reduction, social connection, emotional well-being, and nutrition
Efficacy of multi-modal lifestyle intervention based on any of the 3 specified myeloma tumor burden biomarker surrogates
Efficacy of the multi-modal lifestyle intervention will be based on measurements of 3 myeloma-relevant biomarkers: M-Spike Protein, Free kappa light chains, and Free lambda-light chains. We will first determine which monoclonal protein is dominant for a given patient based on his/her/their individual lab values. These labs will be taken at baseline and compared to levels at 4-, 8-, and 12-month intervals to assess for changes in protein levels.
Time frame: At study entry, 4 months, 8 months, and up to 12 months
Patient Acceptability (engagement) of the Lifestyle Intervention
Patient acceptability will be measured by a patient acceptability questionnaire
Time frame: At study entry, 4 months, 8 months, and up to 12 months
Patient Adherence (compliance) to the Lifestyle Intervention
Patient adherence will be measured based on attendance at clinic visits, the various scheduled individual and group meetings across all intervention components, and via the use of wearable technology
Time frame: At study entry, 4 months, 8 months, and up to 12 months
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