Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Yoga Program Eight-weeks, therapist and self-guided yoga |
Behavioral: Yoga
Participants will attend at least one group class per week (in-person or Zoom) and practice one self-guided yoga video class at home on their own per week, over eight weeks
Participants may choose to attend "Flow Yoga" and/or "Chair Flow Yoga" classes. These classes will be videotaped and made available to participants electronically.
Classes consist of:
guided breathing exercises,
upper and lower extremity stretching
structured postures and movements to improve balance and strength
|
| No Intervention: Treatment as usual Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study. |
Outcome Measures
Primary Outcome Measures
- Number of participants recruited to participate in the study [From enrollment to end of treatment at 8 weeks.]
Feasibility of participant recruitment to the study
- Frequency of yoga practice by participants [From enrollment to end of treatment at 8 weeks.]
Feasibility of participant adherence to the yoga intervention
- Frequency of outcome assessments completed by participants. [From enrollment to end of treatment at 8 weeks.]
Feasibility of participant adherence to outcome assessments
Secondary Outcome Measures
- Acceptability and Satisfaction with Participation in Yoga Intervention [At the end of treatment, 8 weeks after enrollment]
We will use semi-structured interviews to gain information about participants' experience with the yoga program
- Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity [At the time of enrollment and at the end of treatment, 8 weeks after enrollment]
Change in 0 - 10 numerical rating scale of worst chemotherapy-induced peripheral neuropathy pain (via 7-day pain diary) from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 10, with higher scores representing worse pain.
- 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]
Change in European Organization of Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Scale-20 score from enrollment to end of treatment at 8 weeks. Total scores range from 0 - 100, with higher scores representing worse chemotherapy-induced peripheral neuropathy severity.
- Pain Interference [At the time of enrollment and at the end of treatment, 8 weeks after enrollment]
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.6 - 75.6, with higher scores representing worse pain interference.
- Sleep-Related Impairment [At the time of enrollment and at the end of treatment, 8 weeks after enrollment]
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment 8a score from enrollment to the end of treatment at 8 weeks. Total scores range from 30.0 - 80.1 with higher scores representing worse sleep-related impairment.
- 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]
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 40.3 - 81.6, with higher scores representing worse anxiety.
- 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]
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Depression 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 41.0 - 79.4, with higher scores representing worse depression.
- 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]
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 33.7 - 75.8, with higher scores representing worse fatigue.
- Physical Function [At the time of enrollment and at the end of treatment, at 8 weeks.]
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function 4a score from enrollment to the end of treatment at 8 weeks. Total scores range from 22.5 - 57.0, with higher scores representing better physical function.
Eligibility Criteria
Criteria
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,
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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,
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practice yoga >45 minutes per week over the past six months,
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- Oncology Nursing Society
Investigators
- Principal Investigator: Robert Knoerl, PhD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
More Information
Publications
None provided.- 18-578