Идёт набор NCT06807294

Feasibility Testing of a Tai Chi Program for Chemotherapy-Induced Peripheral Neuropathy Treatment (TCT)

Без фазы С лечением Chemotherapy Induced Peripheral Neuropathy (CIPN) Peripheral Neuropathy Due to Chemotherapy Peripheral Neuropathies Neuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Tai Chi Program.
Кому может быть актуально: Состояния в реестре: Chemotherapy Induced Peripheral Neuropathy (CIPN), Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathies, Neuropathy. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Подробное описание

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.

Вмешательства

Поведенческое Tai Chi Program
12-week virtual Tai Chi program with experienced Tai Chi instructor. Sessions will be conducted via the HIPPA-compliant teleconference platform, Zoom.

Первичные конечные точки

Enrollment Rate for the Tai Chi Program [Срок оценки: 6 months]
Assessment Completion Rate [Срок оценки: 12 weeks]
Session Completion Rate [Срок оценки: 12 weeks]
Acceptability of Intervention Measure (AIM) Score [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

Consent Rate (Arm A) [Срок оценки: Up to 6 months (based on total accrual duration)]
Consent Rate (Arm B) [Срок оценки: Up to 6 months (based on total accrual duration)]
Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm A) [Срок оценки: Baseline and 12 weeks]
Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm B) [Срок оценки: Baseline and 12 weeks]
Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm A) [Срок оценки: Baseline and 12 weeks]
Change in Berg Balance Scale (BBS) Score from Baseline to 12 Weeks (Arm B) [Срок оценки: Baseline and 12 weeks]
Change in Fall Rate from Baseline to 12 Weeks (Arm A) [Срок оценки: Baseline and 12 weeks]
Change in Fall Rate from Baseline to 12 Weeks (Arm B) [Срок оценки: Baseline and 12 weeks]
Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm A) [Срок оценки: Baseline and 12 weeks]
Change in the Number of Fall-Related Injuries from Baseline to 12 Weeks (Arm B) [Срок оценки: Baseline and 12 weeks]
Change in Timed-Up-And-Go (TUG) Test from Baseline to 12 Weeks (Arm A) [Срок оценки: Baseline to 12 weeks]
Change in TUG Test from Baseline to 12 Weeks (Arm B) [Срок оценки: Baseline to 12 weeks]

Критерии участия

Критерии включения

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.