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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tai Chi Program

    Behavioral

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

Treatment groups

21 Participants
are divided into 2 treatment groups
Group A: Arm A: Tai Chi Treatment GroupExperimental treatment 1 intervention
Group B: Arm B: Waitlist Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Enrollment Rate for the Tai Chi Program

The intervention is considered feasible if 21 participants are enrolled within the first 6 months of the study period.

Time frame
6 months
2

Assessment Completion Rate

The intervention is considered feasible if 75% of all evaluable participants, 16 out of 21, complete the biobehavioral assessments during the intervention period.

Time frame
12 weeks
3

Session Completion Rate

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.

Time frame
12 weeks
4

Acceptability of Intervention Measure (AIM) Score

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.

Time frame
12 weeks

Secondary outcomes

1

Consent Rate (Arm A)

Defined as the proportion of participants enrolled out of those eligible for study entry.

Time frame
Up to 6 months (based on total accrual duration)
2

Consent Rate (Arm B)

Defined as the proportion of participants enrolled out of those eligible for study entry.

Time frame
Up to 6 months (based on total accrual duration)
3

Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm A)

Assessed by the Berg Balance Scale (BBS), the incidence of falls, fall-related injuries, the Functional Reach Test (FRT) to measure dynamic balance and muscle flexibility (lower scores indicating higher fall risk), the Single Leg Stance Test (SLS) to evaluate static balance with eyes open and closed (abnormal values indicating balance impairment), the Timed Up and Go (TUG) test, the 30-second Chair Stand (30CS) test to assess motor performance (with lower TUG scores and higher 30CS scores reflecting better functional balance, strength, and endurance), and gait speed measurement across an 8-meter hallway under three conditions (quiet walking, fast speed, and cognitive dual task) at baseline and after 12 weeks of Tai Chi training.

Time frame
Baseline and 12 weeks
4

Change in balance, strength, gait health and mobility factors from Baseline to 12 Weeks (Arm B)

Assessed by the Berg Balance Scale (BBS), the incidence of falls, fall-related injuries, the Functional Reach Test (FRT) to measure dynamic balance and muscle flexibility (lower scores indicating higher fall risk), the Single Leg Stance Test (SLS) to evaluate static balance with eyes open and closed (abnormal values indicating balance impairment), the Timed Up and Go (TUG) test, the 30-second Chair Stand (30CS) test to assess motor performance (with lower TUG scores and higher 30CS scores reflecting better functional balance, strength, and endurance), and gait speed measurement across an 8-meter hallway under three conditions (quiet walking, fast speed, and cognitive dual task) at baseline and after 12 weeks of Tai Chi training.

Time frame
Baseline and 12 weeks

Other outcomes

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