Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immediate intervention, Waitlist.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma (MM). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Detailed description
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.
Interventions
- Behavioral Immediate intervention
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 - Other Waitlist
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
Primary outcome measures
- Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function [Time frame: Baseline, Week 16, Week 32, Week 48]
Secondary outcome measures (10)
- Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes. [Time frame: Baseline, Week 16, Week 32, Week 48]
- • Godin Leisure Physical Activity: [Time frame: Baseline, Week 16, Week 32, Week 48]
- • ASA 24-hour Dietary Recall (DR). [Time frame: Baseline, Week 16, Week 32, Week 48]
- • Self-Efficacy for Eating and Exercise Behaviors: [Time frame: Baseline, Week 16, Week 32, Week 48]
- Fruit and Vegetable Intake - objective measure [Time frame: Baseline, Week 16, Week 32, Week 48]
- Outcome Expectancy. [Time frame: Baseline, Week 16, Week 32, Week 48]
- Resilience [Time frame: Baseline, Week 16, Week 32, Week 48]
- Body composition [Time frame: Baseline, Week 16, Week 32, Week 48]
- Objective Physical Activity. (ActivPal): [Time frame: Baseline, Week 16, Week 32, Week 48]
- Lipids and Glucose [Time frame: Baseline, Week 16, Week 32, Week 48]
Eligibility criteria
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 near-term changes in planned myeloma-directed therapy anticipated. (e.g., patient who is 3 months from autologous stem cell transplant just starting on maintenance lenalidomide is eligible since maintenance is planned therapy following transplant)
- no new significant myeloma symptoms (e.g., fractures) meriting changes in anti-neoplastic therapies; AND
- stable performance status (ECOG 0-2)
- 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
- Individuals with <6 months of life anticipated, coexistent amyloidosis, and/or receiving appetite stimulants will not be approached
- Fully adherent to the ACS nutrition and physical activity guidelines
- Currently pregnant or lactating, or anticipating pregnancy
- On another interventional clinical trial that precludes co-enrollment
- Psychiatric or other clinical conditions that preclude study compliance
- Other important medical or safety considerations at the discretion of the investigator(s) and/or approving clinician
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Loyola University Chicago — Maywood
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT07236502 · PRO00040708 · 1R01CA300310