Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma, Smoldering Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to find out whether a dietary approach that includes prolonged overnight fasting, guided by a Mediterranean-style eating pattern, is feasible for patients with myeloma precursor disease or newly diagnosed multiple myeloma.
Interventions
BEHAVIORALHealth Coaching
Participants will receive weekly health coaching sessions via telephone, video call, or in-person. The health coach will contact the participant after randomization to begin the intervention, which will include education on POF and following a Mediterranean diet. Sessions are expected to last 30-45 minutes and may be divided per participant preference. Participant safety and well-being will be addressed at each session, and modifications to the diet or session schedule will be made as necessary and documented. The sessions will be centrally administered by trained nutrition counselors within the Crane Lab under the supervision of a registered dietitian specializing in oncology.
BEHAVIORALProlonged Overnight Fasting (POF)
Participants will be instructed to not consume any calorie-containing food/drinks after 8pm and to wait 14 hours after the fasting start before resuming eating the next day. Participants will use the My Wellness Research (MWR) platform to record fasting start and stop times and times food intake daily. Additionally, workbook containing educational materials and guidance to support adherence to POF goals will be provided. In the first two weeks, participants will be encouraged to fast for at least 12 hours nightly, gradually increasing to 14 hours. Participants will aim to fast up to 14 hours overnight for six days per week, with the option of taking the seventh day off from fasting.
BEHAVIORALMediterranean Diet
Participants will be encouraged to adopt key components of the Mediterranean diet, including consuming 4+ vegetable servings (2.5-3 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week.
BEHAVIORALSupportive Materials
Participants in the intervention arm will be provided with a workbook with information and support to encourage meeting the POF and Mediterranean diet goals. Additionally, participants will be requested to utilize the My Wellness Research (MWR) platform to track their dietary goals as well as a Fitbit. For participants who choose not to use the app, a paper diet tracking sheet will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to the research team each week. Participants will also receive supportive and informational short message service (SMS) text messages 3 times per week during the study; participants can opt-out of these messages.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned to either the intervention or waitlist control group using a 2:1 randomization ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older. 2. Any sex/gender. 3. Able to provide consent. 4. Able to speak, read, and understand English or Spanish. 5. Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard criteria: 1. Cohort 1 - Participants must have a confirmed diagnosis of MGUS and SMM. 2. Cohort 2 - Participants must have a confirmed new diagnosis of MM and be initiating anti-myeloma therapy. 6. Delivery of anti-myeloma therapies at one of the following institutions: 1. Sylvester Comprehensive Cancer Center (SCCC) (including satellite/network sites). 2. University of Miami Health System. 7. Approval from treating oncologist, confirmed via email or in writing. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status grade of \<2 a. PI approval needed if ECOG ≥ 2. 9. Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months. 10. Not consuming a Mediterranean diet by not meeting 2 or more out of the following 3 Mediterranean eating pattern goals in the prior 3 months: ≥3 servings of vegetables per day, ≥ 3 servings of beans and legumes per week, or ≥ 1 serving of nuts per day. Mediterranean diet will be screened with select components of a Mediterranean Diet Adherence Screener (MEDAS). 11. Internet access on a smart phone, tablet, or computer. 12. Willing to be randomized to a prolonged overnight fasting and guided Mediterranean dietary intervention or waitlist-control group.
Exclusion criteria
1. Individuals younger than 18 years of age. 2. Unable to provide consent. 3. Unable to read or understand English or Spanish. 4. Any contraindication for diet changes as determined by physician. 5. History of a clinical eating disorder. 6. History of dementia or major psychiatric disease. 7. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure. 8. History of autoimmune disease and on treatment at time of screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Percentage of Participants That Agree to Participate | Baseline | Feasibility will be measured as the percentage of participants that consent and agree to participate. Criterion for success: At least (≥) 50% of all eligible participants consent to participate. |
| Retention Rate Among Participants Assigned to the Intervention Arm | Up to 35 weeks (8 months) | The retention rate will be reported as the percentage of participants assigned to the intervention arm who complete all intervention sessions. Criterion for success: At least (≥) 80% of all assigned participants complete intervention sessions across both cohorts: * Cohort 1: Participants with Myeloma Precursor Disease * Cohort 2: Participants with Newly Diagnosed Multiple Myeloma (NDMM) |
| Satisfaction Rate Among Participants on Both Arms | Up to 35 weeks (8 months) | The satisfaction rate among participants on both arms (intervention and waitlist control) will be measured via structured exit interviews and reported. Criterion for success: At least (≥) 80% of all participants report satisfaction with the assigned intervention components on both arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Calculated changes in relative dose intensity (RDI) and reasons for change. | Baseline, 24 weeks (6 months), up to 35 weeks (8 months) | Change in anti-myeloma therapy relative dose intensity (RDI) at 24 weeks (6 months) and about 35 weeks (8 months) compared to baseline will be reported between both the intervention and waitlist control arms. RDI is an integrated measure of dose delays and reductions in anti-myeloma therapy. The investigators will calculate the effect sizes for RDI with Cohen's D (Mean difference divided by the pooled standard deviation) and hazard ratio, respectively. The investigators will also calculate those effect sizes for each anti-myeloma therapy. |
| Reason for changes in relative dose intensity (RDI). | Baseline, 24 weeks (6 months), up to 35 weeks (8 months) | The reasons for change in anti-myeloma therapy relative dose intensity (RDI) at 24 weeks (6 months) and about 35 weeks (8 months) compared to baseline will be reported between both the intervention and waitlist control arms. The investigators will run statistical test for the intervention effects on the repeatedly observed RDI at post-intervention and follow-up using the generalized linear mixed model (GLMM) incorporating correlation within-subject. |
Countries
United States
Contacts
CONTACTGrey Freylersythe, BS
CONTACTMichelle Armogan, MHA
PRINCIPAL_INVESTIGATORTracy E Crane, PhD, RDN
University of Miami
PRINCIPAL_INVESTIGATORCarl O Landgren, MD
University of Miami
Outcome results
None listed