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
- 1
- 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
Arms & Interventions
Yoga Program
Eight-weeks, therapist and self-guided yoga
Intervention: Yoga (Behavioral)
Treatment as usual
Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.
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