Dietary Intervention for Multiple Myeloma or Precursor Disease
This study, called FAST-M, is looking at whether a specific dietary approach is practical for people with Multiple Myeloma (a type of blood cancer), Monoclonal Gammopathy of Undetermined Significance (MGUS), or Smoldering Multiple Myeloma (SMM) (these are conditions that can sometimes lead to Multiple Myeloma). The study is testing two behavioral interventions: Prolonged Overnight Fasting (POF), where you don't eat after 8 PM and wait 14 hours before eating again, and following a Mediterranean Diet, which encourages eating lots of vegetables, fruits, whole grains, legumes, nuts, seeds, and seafood. Participants will receive health coaching and supportive materials to help them follow these dietary goals. The main goal is to see if people can stick to these dietary changes and if they are satisfied with the program. The study plans to enroll 120 participants and is currently in an unclear status regarding recruitment. You can join if you are 18 or older, can consent, and have a diagnosis of MGUS, SMM, or Multiple Myeloma.
- Study design
- This is an interventional study, meaning participants will receive specific interventions. It aims to enroll 120 participants.
- What's involved
- Participants will receive weekly health coaching sessions and will be asked to track their fasting and dietary goals using an online platform. The study duration for measuring retention and satisfaction is up to 35 weeks (8 months).
- Compensation
- Not stated in the trial record.
- Follow-up
- Retention and satisfaction rates are measured up to 35 weeks (8 months) after starting the intervention.
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FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Tracy E Crane, PhD, RDN · PRINCIPAL_INVESTIGATOR · University of Miami
- Carl O Landgren, MD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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What this trial measures
- Feasibility: Percentage of Participants That Agree to ParticipateBaseline
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 ArmUp 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 ArmsUp 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.