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| Name | Class |
|---|---|
| Oncology Nursing Society | OTHER |
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This research study will examine the feasibility of conducting an eight-week yoga intervention for individuals with chronic painful chemotherapy-induced peripheral neuropathy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga Program | Experimental | Eight-weeks, therapist and self-guided yoga |
|
| Treatment as usual | No Intervention | Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yoga | Behavioral | 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:
|
| 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. |
| 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 |
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Inclusion Criteria:
-≥18 years of age,
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Knoerl, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34524631 | Derived | Knoerl R, Giobbie-Hurder A, Berfield J, Berry D, Meyerhardt JA, Wright AA, Ligibel JA. Yoga for chronic chemotherapy-induced peripheral neuropathy pain: a pilot, randomized controlled trial. J Cancer Surviv. 2022 Aug;16(4):882-891. doi: 10.1007/s11764-021-01081-z. Epub 2021 Sep 15. | |
| 33772364 | Derived | Knoerl R, Phillips CS, Berfield J, Woods H, Acosta M, Tanasijevic A, Ligibel J. Lessons learned from the delivery of virtual integrative oncology interventions in clinical practice and research during the COVID-19 pandemic. Support Care Cancer. 2021 Aug;29(8):4191-4194. doi: 10.1007/s00520-021-06174-0. Epub 2021 Mar 26. |
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The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Robert Knoerl, PhD; Study PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Data can be shared no earlier than 1 year following the date of publication
Brigham and Women's Hospital - Contact the Partners Innovations team at http://www.partners.org/innovation
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 19, 2020 | Mar 9, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015013 | Yoga |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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|
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. |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D026241 |
| Exercise Movement Techniques |
| D026741 | Physical Therapy Modalities |