Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Percentage of Participants Completing Intervention Sessions
研究概览
简要总结
The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •18 years of age or older
- •Any sex/gender
- •Able to provide consent
- •Able to read or understand English or Spanish
- •Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring at least 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:
- •R-CHOP or R-CHOP-like regimen
- •BV-AVD or ABVD or checkpoint inhibitor+AVD
- •ECOG Performance Status grade of <2
- •a. PI approval needed if ECOG = 2
- •Approval from treating oncologist, confirmed via email or in writing
- •Delivery of chemotherapy treatments at one of the following institutions:
- •Sylvester Comprehensive Cancer Center (including satellite/network sites)
- •University of Miami Hospital/UHealth Tower
- •Internet access on a smart phone, tablet, or computer
- •Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.
排除标准
- •Individuals younger than 18 years of age
- •Unable to provide consent
- •Unable to read or understand English or Spanish
- •Any contraindication for diet change or exercising as determined by physician
- •Currently following a vegan or ketogenic diet, or consuming more than 5 servings of fruit and vegetables per day for the prior month
- •Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
- •History of dementia or major psychiatric disease
- •History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure
研究组 & 干预措施
LIFE-L Group
Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.
干预措施: LIFE-L Mediterranean Diet (Behavioral)
LIFE-L Group
Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.
干预措施: LIFE-L Home-Based Exercise Program (Behavioral)
LIFE-L Group
Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.
干预措施: Supportive Materials (Behavioral)
Control Group
Participants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention.
干预措施: Supportive Materials (Behavioral)
结局指标
主要结局
Percentage of Participants Completing Intervention Sessions
时间窗: Up to 26 weeks (Post-Intervention)
Percentage of intervention session completion at the end of treatment will be assessed, using a threshold of greater than or equal to (\>=) 80-percent.
Change in percentage of participant satisfaction
时间窗: 4 weeks (post-intervention), up to 30 weeks
The change in percentage of participant satisfaction rate at the end of study participation will be assessed, using a threshold of greater than or equal to (\>=) 80-percent. Participant satisfaction will be assessed via exit interviews.
Percentage of Survivors who participate
时间窗: Up to 12 months
Percentage of survivors who agree to participate out of the total number of participants recruited will be assessed using a threshold of greater than or equal to (\>=) 50-percent.
次要结局
- Average Relative Dose Intensity (RDI)(Up to 30 weeks)
研究者
Tracy E Crane, PhD, RDN
Associate Professor
University of Miami