Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Enrollment Rate for the Tai Chi Program
研究概览
简要总结
This research is being done to determine whether a 12-week virtual Tai Chi training program, designed to improve balance and small nerve fiber function, is feasible and acceptable among cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN).
详细描述
This is a prospective, randomized, waitlist-controlled pilot trial to examine the suitability of the virtual Tai Chi program in cancer survivors with CIPN. Tai Chi is a mind-body practice that involves gentle body movements, meditation, and breathing techniques. It has proven to be effective in enhancing balance control and relieving musculoskeletal pains.
This study randomly assigns cancer survivors with CIPN with self-perceived balance difficulties to one of two groups: Group A Tai Chi Group versus Group B Waitlist Group. Randomization means a participant is placed into a study group by chance.
The research study procedures including screening for eligibility, questionnaires, and sensory and functional testing.
Participation in this study is expected to last for up to 12 weeks.
It is expected that about 21 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
- •Age 18 years old and older
- •Cancer survivors with no evidence of disease (cancer);
- •Completed neurotoxic chemotherapy, i.e., platinum agents, taxanes, vinca alkaloids, and bortezomib, at least three months before enrollment;
- •A CIPN diagnosis based on symptom history, loss of deep tendon reflexes, or presence of symmetrical stocking-glove pain, numbness, or paresthesia;
- •Answers "yes" to the following question: "Do you feel as though your balance is affected from experiencing CIPN?" or "Are you afraid of falling as a result of your CIPN?";
- •On a stable regimen (no change in past three months) if taking anti-neuropathy or other pain medications;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Scale score ≤ 2
- •Willing to adhere to all study-related procedures, including randomization to the Tai Chi or waitlist group, 2 in-person visits to Dana-Farber Cancer Institute (DFCI) (one within 2 weeks of enrollment and one at week 12);
- •Willing to adhere to requirement that no new pain medication be taken throughout the study period; and
- •Individuals receiving endocrine therapy or targeted/antibody therapy, such as trastuzumab, pertuzumab, or immunotherapy, will be eligible to participate.
排除标准
- •Patients who have received physical therapy or Tai Chi training, specifically for CIPN, in the past three months.
研究组 & 干预措施
Arm A: Tai Chi Treatment Group
14 randomized participants will complete:
- 1 baseline visit session.
- Virtual Tai Chi session 2x weekly (60 minutes per session).
- Independent Tai Chi sessions 3 days a week (60 minutes per session).
- 12 week follow up visit.
干预措施: Tai Chi Program (Behavioral)
Arm B: Waitlist Control Group
7 randomized participants will complete:
- 1 baseline visit session
- Standard CIPN care prescribed by primary care physician/oncologist.
- 12 week follow up visit
- Participants will be offered 24 complimentary, virtual, Tai Chi training sessions over 12 weeks after completion of the 12-week follow-up visit.
结局指标
主要结局
Enrollment Rate for the Tai Chi Program
时间窗: 6 months
The intervention is considered feasible if 21 participants are enrolled within the first 6 months of the study period.
Assessment Completion Rate
时间窗: 12 weeks
The intervention is considered feasible if 75% of all evaluable participants, 16 out of 21, complete the biobehavioral assessments during the intervention period.
Session Completion Rate
时间窗: 12 weeks
The intervention is considered feasible if 62% of participants in the intervention arm, 9 out of 14, attend at least 80% or 20 of the 24 online sessions.
Acceptability of Intervention Measure (AIM) Score
时间窗: 12 weeks
Assessed by the Acceptability of the Intervention Measure (AIM), 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.
次要结局
- Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm A)(Baseline and 12 weeks)
- Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm B)(Baseline and 12 weeks)
- Consent Rate (Arm A)(Up to 6 months (based on total accrual duration))
- Consent Rate (Arm B)(Up to 6 months (based on total accrual duration))
- Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm A)(Baseline and 12 weeks)
- Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm B)(Baseline and 12 weeks)
- Change in Fall Rate from Baseline to 12 Weeks (Arm A)(Baseline and 12 weeks)
- Change in Fall Rate from Baseline to 12 Weeks (Arm B)(Baseline and 12 weeks)
- Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm A)(Baseline and 12 weeks)
- Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm B)(Baseline and 12 weeks)
- Change in Timed-Up-And-Go (TUG) Test from Baseline to 12 Weeks (Arm A)(Baseline to 12 weeks)
- Change in TUG Test from Baseline to 12 Weeks (Arm B)(Baseline to 12 weeks)
- Change in Brief Pain Inventory-Short For (BPI-SF) Score from Baseline to 12 Weeks (Arm A)(Baseline to 12 weeks)
- Change in BPI-SF Score from Baseline to 12 Weeks (Arm B)(Baseline to 12 weeks)
- Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm A)(Baseline to 12 weeks)
- Change in the Neurotoxicity (Ntx) Subscale Score from Baseline to 12 Weeks (Arm B)(Baseline and 12 weeks)
- Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm A)(Baseline and 12 weeks)
- Change in Tactile Threshold Value from Baseline to 12 Weeks (Arm B)(Baseline and 12 weeks)
- Change in Vibration Threshold Value from Baseline to 12 weeks (Arm A)(Baseline to 12 weeks)
- Change in Vibration Threshold Value from Baseline to 12 weeks (Arm B)(Baseline to 12 weeks)
- Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm A)(Baseline to 12 weeks)
- Change in the Short Falls Efficacy Scale - International (Short FES-I) from Baseline to 12 Weeks (Arm B)(Baseline to 12 weeks)
- Change in Functional Reach Test from Baseline to 12 Weeks (Arm A)(Baseline to 12 weeks)
- Change in Functional Reach Test from Baseline to 12 Weeks (Arm B)(Baseline to 12 weeks)
研究者
Weidong Lu, MB, MPH, PhD
Principle Investigator
Dana-Farber Cancer Institute