Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: Waitlist (Other)
结局指标
主要结局
Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function
时间窗: 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.
次要结局
- 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)
研究者
Melinda Stolley
Principal Investigator
Medical College of Wisconsin