The purpose of this project is to evaluate the impact of a 16-week lifestyle program that promotes changes in eating and exercise patterns. The main questions the study will answer are:
Do improvements in eating and exercise patterns lead to improved physical function, quality of life and blood biomarkers of biologial aging among individuals with multiple myeloma? Participants will complete study activities 3-4 times during the study.
1. In-person assessment to measure physical function, height/weight, body composition, and includes a blood draw 2. Surveys completed online or on paper at home
Adult (≥ 18 years)
Diagnosed with MM at least one year prior to study enrollment
100 days post transplant (if applicable)
Has access to a smart phone or device with internet access
Coexistent amyloidosis, POEMS syndrome will not be approached
Fully adherent to the ACS nutrition and physical activity guidelines
If participant is of child-bearing age they cannot be pregnant, planning to come pregnant or lactating during the study period
On another interventional clinical trial that precludes co-enrollment
Crossover
Immediate intervention
Behavioral16-session intervention that facilitates changes in nutrition and physical activity behaviors to promote improvements in physical function, Patient Reported Outcomes, body composition and general health
Waitlist
Other interventionParticipants will be asked to maintain their behavior over the 16 week waitlist period and will receive weekly text message relating positive messages unrelated to lifestyle
Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function
Changes in performance-based physical function between the interventional and control groups will be measured using the Short Physical Performance Battery (SPPB), which comprises a 4-meter walk test to assess gait speed, sit-to-stand test to assess lower body strength, and standing balance tests to assess balance. Scoring for the SPPB ranges from 0 to 12; higher scores indicate higher function.
Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes.
Changes in patient-reported outcomes between the interventional and control groups will be measured using: the Patient Reported Outcomes Measurement Information System (PROMIS) physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, pain intensity, satisfaction with social roles and activities, instrumental support, informational support, emotional support, companionship, cognitive function and social isolation. The PROMIS measures for this study will be used in a CAT Computer adaptive format.
• Godin Leisure Physical Activity:
A tool querying about light, moderate, strenuous activities over 7-days and one item asking about strength training
• ASA 24-hour Dietary Recall (DR).
Supported by the National Cancer Institute's ASA24 and with administrative assistance, a minimum of 2 unannounced 24DR will be completed pre/post-intervention using the 5-pass dietary recall methodology.
• Self-Efficacy for Eating and Exercise Behaviors:
A validated tool consisting of 12 items to assess exercise self-efficacy and 20 items to assess healthy eating and exercise self-efficacy
Inflammation
Examine the associations between lifestyle behaviors and serum biomarkers for inflammation. Markers of inflammation including CRP, IL-6; TNF-alpha will be analyzed (blind to randomization) in batch at the end of data collection using commercially available ELISA kits. Each sample will be assayed in duplicate and repeated if variability exceeds 15%.
Biological Aging
o Biological Aging/Cellular Senescence. Additional blood samples will be collected in PAXgene RNA (2.5 mL) tubes and stored (-80° C). Cellular senescence will be assessed via transcript abundance of the p16INK4a- and p21-encoding genes (CDKN2A and CDKN1A, respectively).23-25 A priori-defined sets of genes known to be up-regulated during the DNA damage response (DDR; 30 genes; e.g., CHEK1, SIRT1, TP53, TERF2), and the senescence-associated secretory phenotype (SASP; 61 genes; e.g., IL1A, IL13, CXCL8, CSF2, VEGF) will also be assessed.
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Medical College of Wisconsin
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Loyola University Chicago
Collaborator
