Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Frequency of yoga practice by participants
Study Overview
Brief Summary
This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.
Detailed Description
This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy. The investigators will also explore participants' perceptions of acceptability and satisfaction with the yoga intervention. Lastly, the investigators will examine changes in chemotherapy-induced peripheral neuropathy severity, physical function, sleep-related impairment, fatigue, anxiety, depression, and pain following the eight-week yoga intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age,
- •self-report ≥ 4/10 worst chemotherapy-induced peripheral neuropathy pain over the past week,
- •at least three months post neurotoxic chemotherapy completion
- •signed informed consent,
- •willingness to participate in all study activities
- •speak/read English
Exclusion Criteria
- •prognosis of less than three months,
- •documented peripheral neuropathy due to other causes (e.g., diabetes),
- •planned receipt of neurotoxic chemotherapy during the study period,
- •practice yoga >45 minutes per week over the past six months,
- •diagnosis or documented recent history of significant psychiatric comorbidity (i.e., psychosis, suicidal ideation, or substance abuse)
- •clinician deems that the patient is physically/functionally unable to participate in a yoga program
Outcomes
Primary Outcomes
Frequency of yoga practice by participants
Time Frame: From enrollment to end of treatment at 8 weeks.
Feasibility of participant adherence to the yoga intervention
Number of participants recruited to participate in the study
Time Frame: From enrollment to end of treatment at 8 weeks.
Feasibility of participant recruitment to the study
Frequency of outcome assessments completed by participants.
Time Frame: From enrollment to end of treatment at 8 weeks.
Feasibility of participant adherence to outcome assessments
Secondary Outcomes
- Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Physical Function(At the time of enrollment and at the end of treatment, at 8 weeks.)
- Anxiety assessed by the "Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety"(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Acceptability and Satisfaction with Participation in Yoga Intervention(At the end of treatment, 8 weeks after enrollment)
- Pain Interference(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Chemotherapy-Induced Peripheral Neuropathy Severity(From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Sleep-Related Impairment(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
- Depression assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression(At the time of enrollment and at the end of treatment, 8 weeks after enrollment)
Investigators
Robert Knoerl, PhD, RN
Principal Investigator
Dana-Farber Cancer Institute