Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma
Purpose
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
Condition
- Multiple Myeloma (MM)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Adult (≥ 18 years) 2. Diagnosed with MM at least one year prior to study enrollment 3. Has access to a cell phone 4. Be deemed "clinically stable" by their physician guided by the following: 1. 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) 2. no new significant myeloma symptoms (e.g., fractures) meriting changes in anti-neoplastic therapies; AND 3. stable performance status (ECOG 0-2) 5. 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)]. 6. Able to participate in moderate PA and strength training per clinician approval and confirmed by participant 7. Able to understand and willing to sign a written informed consent document 8. 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 2. Fully adherent to the ACS nutrition and physical activity guidelines 3. Currently pregnant or lactating, or anticipating pregnancy 4. On another interventional clinical trial that precludes co-enrollment 5. Psychiatric or other clinical conditions that preclude study compliance 6. Other important medical or safety considerations at the discretion of the investigator(s) and/or approving clinician
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Waitlist Control
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. The intervention targets plant-based eating, increasing physical activity and strength training. |
|
|
Active Comparator Waitlist control |
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. |
|
Recruiting Locations
Maywood, Illinois 60153
Milwaukee, Wisconsin 53226
More Details
- Status
- Recruiting
- Sponsor
- Medical College of Wisconsin
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.