Moving Forward With Myeloma: A Lifestyle Intervention for Individuals With Multiple Myeloma

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Другое 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

Первичные конечные точки

• Examine the efficacy of the intervention in producing post-intervention changes in performance-based physical function [Срок оценки: Baseline, Week 16, Week 32, Week 48]

Вторичные конечные точки (10)

• Examine the efficacy of the intervention in producing post-intervention changes in patient-reported outcomes. [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• • Godin Leisure Physical Activity: [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• • ASA 24-hour Dietary Recall (DR). [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• • Self-Efficacy for Eating and Exercise Behaviors: [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• Fruit and Vegetable Intake - objective measure [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• Outcome Expectancy. [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• Resilience [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• Body composition [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• Objective Physical Activity. (ActivPal): [Срок оценки: Baseline, Week 16, Week 32, Week 48]
• Lipids and Glucose [Срок оценки: Baseline, Week 16, Week 32, Week 48]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Loyola University Chicago — Maywood
• Medical College of Wisconsin — Milwaukee

Идентификаторы

NCT: NCT07236502 · PRO00040708 · 1R01CA300310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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