Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical College of Wisconsin
- Enrollment
- 184
- Locations
- 2
- Primary Endpoint
- Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function
Study Overview
Brief Summary
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.
- In-person assessment to measure physical function, height/weight, body composition, and includes a blood draw
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Immediate intervention (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. The intervention targets plant-based eating, increasing physical activity and strength training.
Intervention: Immediate intervention (Behavioral)
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.
Intervention: Waitlist (Other)
Outcomes
Primary Outcomes
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
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.
Secondary Outcomes
- Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes.(Baseline, Week 16, Week 32, Week 48)
- • Godin Leisure Physical Activity:(Baseline, Week 16, Week 32, Week 48)
- • ASA 24-hour Dietary Recall (DR).(Baseline, Week 16, Week 32, Week 48)
- • Self-Efficacy for Eating and Exercise Behaviors:(Baseline, Week 16, Week 32, Week 48)
- Fruit and Vegetable Intake - objective measure(Baseline, Week 16, Week 32, Week 48)
- Outcome Expectancy.(Baseline, Week 16, Week 32, Week 48)
- Resilience(Baseline, Week 16, Week 32, Week 48)
- Body composition(Baseline, Week 16, Week 32, Week 48)
- Objective Physical Activity. (ActivPal):(Baseline, Week 16, Week 32, Week 48)
- Lipids and Glucose(Baseline, Week 16, Week 32, Week 48)
Investigators
Melinda Stolley
Principal Investigator
Medical College of Wisconsin