Chemotherapy-induced Peripheral Neuropathy, Chronic Pain, Neuropathic Pain, Yoga
Conditions
Keywords
Chemotherapy-induced Peripheral Neuropathy, Yoga, Chronic Pain, Neuropathic Pain
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.
Interventions
BEHAVIORALYoga
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
Sponsors
Oncology Nursing Society
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed