Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study

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.

Official Title
-----------------
Yoga for Painful Chemotherapy-Induced Peripheral Neuropathy: A Pilot, Randomized-Controlled Study

Conditions
-----------------
Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain, Neuropathic Pain

Intervention / Treatment
-----------------
* Behavioral: Yoga


Participation Criteria
=================
Eligibility 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, 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Program<br>Eight-weeks, therapist and self-guided yoga | Behavioral: Yoga<br>* 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<br>|
| No Intervention: Treatment as usual<br>Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants recruited to participate in the study | Feasibility of participant recruitment to the study | From enrollment to end of treatment at 8 weeks. | 
| Frequency of yoga practice by participants | Feasibility of participant adherence to the yoga intervention | From enrollment to end of treatment at 8 weeks. | 
| Frequency of outcome assessments completed by participants. | Feasibility of participant adherence to outcome assessments | From enrollment to end of treatment at 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and Satisfaction with Participation in Yoga Intervention | We will use semi-structured interviews to gain information about participants' experience with the yoga program | At the end of treatment, 8 weeks after enrollment | 
| Worst Chemotherapy-Induced Peripheral Neuropathy Pain Intensity | 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. | At the time of enrollment and at the end of treatment, 8 weeks after enrollment | 
| Chemotherapy-Induced Peripheral Neuropathy Severity | 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. | From enrollment to end of treatment at 8 weeks.At the time of enrollment and at the end of treatment, 8 weeks after enrollment | 
| Pain Interference | 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. | At the time of enrollment and at the end of treatment, 8 weeks after enrollment | 
| Sleep-Related Impairment | 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. | At the time of enrollment and at the end of treatment, 8 weeks after enrollment | 
| Anxiety assessed by the Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety | 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. | 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 | 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. | At the time of enrollment and at the end of treatment, 8 weeks after enrollment | 
| Fatigue assessed by Change in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue | 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. | At the time of enrollment and at the end of treatment, 8 weeks after enrollment | 
| Physical Function | 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. | At the time of enrollment and at the end of treatment, at 8 weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain, Neuropathic Pain