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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA300310 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Loyola University Chicago | OTHER |
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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.
The study uses a randomized, waitlist control design. Following baseline data collection, participants will be randomized to either the immediate lifestyle intervention group or the waitlist control group. Those who are randomized to the waitlist control group will receive the intervention after the 16-week data collection time point.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | 16-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. The intervention targets plant-based eating, increasing physical activity and strength training. |
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| Waitlist control | Active Comparator | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate intervention | Behavioral | 16-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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 16, Week 32, Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Baseline, Week 16, Week 32, Week 48 |
Inclusion Criteria:
Adult (≥ 18 years)
Diagnosed with MM at least one year prior to study enrollment
Has access to a cell phone
Be deemed "clinically stable" by their physician guided by the following:
No reports of severe pain > Grade 3 [defined by the NCI CTCAE as tumor, neurologic, bone, or other pain interfering with self-care ADLs (bathing, dressing, toileting, continence, feeding)].
Able to participate in moderate PA and strength training per clinician approval and confirmed by participant
Able to understand and willing to sign a written informed consent document
English proficient for reading and writing
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melinda Stolley, PhD | Contact | (312)735-6044 | mstolley@mcw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melinda Stolley, PhD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Chicago | Maywood | Illinois | 60153 | United States |
De-identified data on participant characteristics and outcomes will be shared.
Once the study is completed, de-identified data collected during the study will be made available.
Once the study is completed, de-identified data collected during the study will be deposited in the Harvard Dataverse. Raw RNA-seq, alignment, and transcript data will be made available to the research community free of charge through GEO. Since the purpose of this data sharing is to answer questions in the future, your
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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Waitlist Control
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| Waitlist | Other | Participants 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 |
|
| Baseline, Week 16, Week 32, Week 48 |
| • Godin Leisure Physical Activity: | A tool querying about light, moderate, strenuous activities over 7-days and one item asking about strength training | Baseline, Week 16, Week 32, Week 48 |
| • 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. | Baseline, Week 16, Week 32, Week 48 |
| • 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 | Baseline, Week 16, Week 32, Week 48 |
| Fruit and Vegetable Intake - objective measure | • Veggie meter- Participants will be asked to complete reflective spectroscopy using the Veggie Meter; a device that non-invasively measures the level of carotenoid pigments in the skin. | Baseline, Week 16, Week 32, Week 48 |
| Outcome Expectancy. | • Measures positive and negative outcome expectations ("I would sleep more soundly if I exercised regularly"; "Regular exercise would increase my pain.") Higher scores indicate greater positive or negative outcome expectations. | Baseline, Week 16, Week 32, Week 48 |
| Resilience | • The Brief Resilience Scale (BRS) is a psychological measure designed to quantify a person's ability to 'bounce back' or recover from stressful events or trauma | Baseline, Week 16, Week 32, Week 48 |
| Body composition | • DEXA imaging is a 10-minute, noninvasive technique that provides precise whole-body measures of fat (total and visceral) and lean mass. Certified DXA technologists will perform and analyze whole body measures using the same machine for each participant at each time point) | Baseline, Week 16, Week 32, Week 48 |
| Objective Physical Activity. (ActivPal): | • Participants wear this device on the right thigh, held on by a Tegaderm patch to measure PA and sedentary time. Data are downloaded using ActiLife software and will be analyzed using recommended thresholds for moderate and vigorous PA. | Baseline, Week 16, Week 32, Week 48 |
| Lipids and Glucose | Utilizing clinical resources at MCW or LUC phlebotomy will be performed by trained personnel to conduct fasting blood draws and blood processing according to standard procedures. Whole blood will be collected, allowed to clot for 20 mins, and centrifuged at 2,500 rpm for 20 mins. o Lipids (HDL, LDL, Total Cholesterol, Triglycerides) and glucose measures will be procured using the Choletech LDX (Abbott, Inc.) | Baseline, Week 16, Week 32, Week 48 |
| 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. | Baseline, Week 16, Week 32 |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |