Interrupting Sedentary Time to Improve Cardiometabolic Health and Toxicity in Patients With Lymphoma Receiving Chemotherapy: The iSTAND Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Intervention Completion Rate (Feasibility)
研究概览
简要总结
This study aims to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.
详细描述
The purpose of this study is to see if a 12-week exercise program designed to reduce long periods of inactivity is feasible in newly diagnosed lymphoma participants receiving R-CHOP or POLA-R-CHP chemotherapy treatments, and whether it can improve heart health and reduce chemotherapy drug side effects.
Participants will be randomized into one of two groups: Group A: Interrupted Sedentary Time Intervention vs. Group B: Usual Care Control Group. Randomized means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, assessments of fitness and physical health, blood tests, and questionnaires.
Participation in this research study is expected to last about 3 months.
It is expected that about 24 people will take part in this research study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign informed consent prior to any study- related procedures.
- •Patients diagnosed with lymphoma.
- •Will receive first line R-CHOP or POLA-R-CHP chemotherapy regimens, patients do not need to be within a certain timeframe from diagnosis.
- •Aged ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included.
- •Engaging in ≤60-minutes of structured moderate or vigorous intensity exercise.
- •Have physician clearance to participate in exercise.
- •Speak English.
- •Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.
- •Access to a phone that can receive text messages.
排除标准
- •Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
- •Participate in more than 60 minutes of structured moderate-to-vigorous exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current interrupted sedentary time intervention.
- •Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting lymphoma chemotherapy-related effects.
- •Patients currently taking weight loss drugs.
- •Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.
- •Unable to travel to DFCI Longwood campus for necessary data collection and chemotherapy infusions.
研究组 & 干预措施
Interrupted Sedentary Time Intervention
The first 3 participants enrolled with be placed into the intervention group. After this, participants will be randomized in a group allocation ratio of 2:1 using permuted blocked design with varying block size and stratified by treatment plan. 14 participants will complete:
- Baseline visit
- Standard of care chemotherapy treatment regimen
- Daily exercise sessions in-clinic up to 4x weekly and at home 6 days per week
- Week 14 post-intervention visit
干预措施: Interrupted Sedentary Time Intervention (Behavioral)
Usual Care Control Group
Participants will be randomized in a group allocation ratio of 2:1 using permuted blocked design with varying block size and stratified by treatment plan. 7 participants will complete:
- Baseline visit
- Standard of Care chemotherapy treatment regimen
- Week 14 visit
- Participants will be offered Fitbit activity tracker and resistance bands at the end of the study.
结局指标
主要结局
Intervention Completion Rate (Feasibility)
时间窗: 12 weeks
Intervention feasibility is defined as: 1) A participant completes ≥70% of the supervised activity breaks on at least 3 out of the 4 infusion appointments. 2) A participant completes ≥70% of the prescribed home-based resistance activity breaks on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention). 3) A participant completes ≥70% of the prescribed home-based step goals (i.e., \>250 steps per hour) on at least 48 days out of the possible 68 days (12 week) intervention (excluding the 4 infusion days and 1 rest day per week) (i.e., meet interrupting sedentary behavior goals across at least 70% of the intervention).
Refusal Rate
时间窗: 12 weeks
Defined as ≤50% of eligible screened participants refuse to complete intervention.
Retention Rate
时间窗: 13 weeks
Retention of consented participants to study end is ≥70%.
Acceptability of Intervention Measure (AIM) Scale
时间窗: 13 weeks
Assessed by the Acceptability of the Intervention Measures, a 4-item measure rated on a 5-point Likert scale with answers ranging from "Completely disagree" to "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability. The intervention will be deemed acceptable by participants if ≥70% of participants have a mean score ≥ 4 on the AIM.
Acceptability Exit Survey
时间窗: 13 weeks
The intervention will be deemed acceptable by participants if 1) ≥70% of participants report "agree" or "strongly agree" to the prompt "Participation in this study helped me reduce my daily sedentary time" and 2) ≥70% of participants report "probably" or "yes" to the prompt "I would recommend this program to other patients being treated for cancer."
次要结局
- Participant Glucose Level(Assessed for one week at each timepoint (baseline & post-intervention).)
- Participant Insulin Resistance(Assessed for one week at each timepoint (baseline & post-intervention).)
研究者
Christina Dieli-Conwright, PhD
Principal Investigator
Dana-Farber Cancer Institute