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

NCT ID: NCT03824860

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-06

Study Completion Date

2021-02-18

Brief Summary

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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.

Detailed Description

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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. 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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy Yoga Chronic Pain Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Yoga Program

Eight-weeks, therapist and self-guided yoga

Group Type EXPERIMENTAL

Yoga

Intervention Type 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:

* guided breathing exercises,
* upper and lower extremity stretching
* structured postures and movements to improve balance and strength

Treatment as usual

Control group participants will continue to receive usual care and symptom management strategies from clinicians during the study.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oncology Nursing Society

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Robert Knoerl, PhD, RN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Knoerl, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34524631 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33772364 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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18-578

Identifier Type: -

Identifier Source: org_study_id

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