NutriCare Intervention on Optimizing Nutritional Status, Reducing Treatment-Related Toxicities, and Improving Quality of Life Among Vulnerable Patients With Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 299
- 试验地点
- 8
- 主要终点
- Weight
研究概览
简要总结
The NutriCare study aims to develop, implement, and evaluate the efficacy of an innovative intervention strategy (medically tailored meals plus nutrition counseling) to integrate nutrition into the standard of care for oncology to improve outcomes of vulnerable patients with lung cancer. The NutriCare study evaluates the efficacy of the intervention on optimizing nutritional status, reducing treatment-related toxicities, and improving the quality of life of patients with lung cancer who are economically disadvantaged, uninsured, racial and ethnic minorities, elderly, and/or rural residents from four major medical centers in diverse regions of the United States (U.S.). There will be two cohorts for NutriCare with cohort 1 recruiting 150 patients completing an 8-month intervention and cohort 2 recruiting 120 patients completing a 6-month intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18+ years of age)
- •Newly diagnosed patients with lung cancer (non-small cell and small cell lung cancer):
- •Patients with stages I-III lung cancer:
- •1) starting multimodality therapy including chemoradiation (either concurrent or sequential), systemic treatment, or radiation alone; and may be followed by surgery; or 2) starting adjuvant therapy after lung resection ((chemotherapy alone, radiation alone, or chemoradiation (either concurrent or sequential))
- •Patients with stage IV lung cancer or recurrent/metastatic:
- •Eligible at diagnosis and for up to 3 months after starting treatment
- •o Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-3
- •Vulnerable patients who meet at least one of the following criteria:
- •Economically disadvantaged (household gross monthly income at or below 130% of the Federal Poverty Level)
- •Racial and ethnic minorities (African Americans, American Indians and Alaska Natives, Asians and Pacific Islanders, and Hispanics)
- •No health insurance
- •Elderly patients (ages 65 years or older)
- •Reside in rural areas (non-metropolitan counties with less than 50,000 people)
- •Voluntarily provide consent, HIPPA authorization form, and consent from treating oncologist.
- •Able to speak and read English themselves or with minimal help.
- •Able to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, and willing to sign the MTM agreement.
排除标准
- •Cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program.
- •Have medical conditions that significantly impact digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon; pancreas dysfunction; brain surgery that alters cognition; severe food allergies; etc.) or have active metabolic or digestive illnesses (i.e., Celiac disease, IBS, renal insufficiency, hepatic insufficiency).
- •Pregnant or planning to become pregnant during the study.
- •Unable to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, including lack of a permanent address to which meals can be delivered (a friend or home address is acceptable given it is used on a consistent basis), not having a fully functioning kitchen with a microwave or oven for cooking, not having a standard-sized refrigerator with a freezer with storage capacity to hold one week's worth of meals; or unwilling to sign the MTM agreement.
结局指标
主要结局
Weight
时间窗: Recorded at each clinical visit. From date of beginning baseline until the date of completing the final (6 or 8 month) study visit, an average of 3-4 clinic visits dependent on course of treatment.
Change in weight measured in the clinic
Weight
时间窗: Recorded at each clinical visit. From date of beginning baseline until the date of completing the final (6 or 8 month) study visit, an average of 3-4 clinic visits dependent on course of treatment.
Change in weight measured in the clinic
Nutritional Intake
时间窗: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Change in diet quality and intake of key food groups and nutrients as assessed by the National Cancer Institute Diet History Questionnaire (DHQ III)
次要结局
- Food Insecurity(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Patient-reported Symptoms(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Treatment-related Toxicities(From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.)
- Patient-reported Functional Outcomes - Anxiety(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Treatment Compliance(Recorded at each clinical visit. From date of beginning baseline until the date of completing the final (6 or 8 month) study visit, an average of 3-4 clinic visits dependent on course of treatment.)
- Gut Microbial Composition(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Cancer Mortality(5-8 Years)
- Patient-reported Functional Outcomes - Depression(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Health-Related Quality of Life in Cancer Patients(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Quality of Life in Lung Cancer Patients(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Hospitalizations(From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.)
- ED visits(From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.)
- Patient-reported Symptoms(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Food Insecurity(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Hospitalizations(From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.)
- Treatment-related Toxicities(From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.)
- Treatment Compliance(Recorded at each clinical visit. From date of beginning baseline until the date of completing the final (6 or 8 month) study visit, an average of 3-4 clinic visits dependent on course of treatment.)
- Gut Microbial Composition(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Cancer Mortality(5-8 Years)
- Patient-reported Functional Outcomes - Anxiety(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Patient-reported Functional Outcomes - Depression(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Health-Related Quality of Life in Cancer Patients(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- Quality of Life in Lung Cancer Patients(Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1])
- ED visits(From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.)
研究者
Fang Fang Zhang
Associate Professor, The Neely Family Professor and Associate Professor
Tufts University