Moving Foward With Myeloma (MFM)

N/ANot Yet RecruitingNCT07236502

Medical College of Wisconsin184 enrolled

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

184

Conditions

Multiple Myeloma (MM)

Interventions

Immediate interventionBEHAVIORAL

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

WaitlistOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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: 1. 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

Locations (2)

Loyola University Chicago

Maywood, Illinois, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function

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.

Time frame: Baseline, Week 16, Week 32, Week 48

Secondary Outcomes

Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes.

Changes in patient-reported outcomes between the interventional and control groups will be measured using: the Patient Reported Outcomes Measurement Information System (PROMIS) physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, pain intensity, satisfaction with social roles and activities, instrumental support, informational support, emotional support, companionship, cognitive function and social isolation. The PROMIS measures for this study will be used in a CAT Computer adaptive format.

Time frame: Baseline, Week 16, Week 32, Week 48

• Godin Leisure Physical Activity:

A tool querying about light, moderate, strenuous activities over 7-days and one item asking about strength training

Time frame: Baseline, Week 16, Week 32, Week 48

• ASA 24-hour Dietary Recall (DR).

Supported by the National Cancer Institute's ASA24 and with administrative assistance, a minimum of 2 unannounced 24DR will be completed pre/post-intervention using the 5-pass dietary recall methodology.

Time frame: Baseline, Week 16, Week 32, Week 48

• Self-Efficacy for Eating and Exercise Behaviors:

Central Contacts

Melinda Stolley, PhD

CONTACT

(312)735-6044 mstolley@mcw.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.