Effects of Reiki, Yoga, Meditation, on the Physical and Psychological Symptoms of Chemotherapy-Induced Peripheral Neuropathy

NCT01569269 | Completed

• 1 other identifier: 6870
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether people with symptoms of chemotherapy-induced peripheral neuropathy (CIPN) receive physical or psychological benefits from participating in a six-week Reiki, Yoga, Meditation, or Educational experience.

Conditions

Peripheral Neuropathy

Keywords

chemotherapy induced peripheral neuropathy; cancer; psychological distress; mindfulness; complementary and alternative

Outcome Measures

Primary Outcomes (1)

• FACT GOG-ntx scale

  This scale measures two outcomes:symptoms of neurotoxicity and quality of life. The FACT GOG-ntx combines the 27-item general Functional Assessment of Cancer Therapy scale (FACT-G) with an 11-item neurotoxicity subscale. Completion of the FACT-G does not require assistance and can be completed in less than five minutes. Cronbach's coefficient for each item on this scale has been demonstrated at 0.70 or higher, and the instrument is sensitive to respondent changes over time.

  change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks

Secondary Outcomes (2)

• The Brief Symptom Inventory - 18 (BSI-18)

  change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks

• Mindful Attention Awareness scale (MAAS)

  change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks

Study Arms (4)

Yoga

EXPERIMENTAL

See intervention description

Behavioral: Yoga Intervention

Meditation

EXPERIMENTAL

See intervention description

Behavioral: Meditation Intervention

Reiki

EXPERIMENTAL

see intervention description

Behavioral: Reiki

Holistic Education

ACTIVE COMPARATOR

see intervention description

Other: Holistic Education

Interventions

Yoga Intervention BEHAVIORAL

The yoga intervention will take place for one hour per week for six weeks. All sessions will be guided by a Registered Yoga Teacher (RYT) who is also a Licensed Clinical Social Worker (LCSW). Each yoga session will follow a similar protocol. The introductory period (10 minutes) will focus participants on increasing interoceptive and proprioceptive capacity. The main segment is comprised of a series of yoga postures that progress from lying or seated postures that provide gentle muscle stretching to standing stretches that increase balance and flexibility. The postures will be introduced, practiced, and combined with breathing exercises for forty minutes. The conclusion of the session will be comprised of 10 minutes of relaxation.

Yoga

Meditation Intervention BEHAVIORAL

The meditation intervention will be conducted weekly for weeks. Each class will follow a similar protocol: During the one-hour meeting, participants will focus on developing attention to the breath. In a supine or seated position and with eyes closed, participants will be guided to attend solely to their breathing. As physical sensations, thoughts, and emotions begin to arise, participants will be taught to recognize, acknowledge, and accept the presence of the sensations or emotions and then to step back, release the thought or sensation, and refocus attention toward the breath At the conclusion of each meeting, the meditation instructor will encourage participants to voluntarily engage in daily meditation practices.

Meditation

Reiki BEHAVIORAL

The Reiki intervention will be conducted for one hour per week for 6 weeks. Protocol for each session: Briefly meet with the Reiki practitioner to review experiences with symptoms of CIPN. Then, the participant will be directed to lie supine and fully clothed on a massage table. Beginning at the top of the head, the practitioner will move inferiorly and pause while holding their hands above, but facing the participant at each energy point until reaching the feet. Upon reaching the participant's feet, the participant will roll from the supine position to a prone position and the process repeated. After being guided to a seated position on the massage table, the practitioner will spend a few moments in conversation with the participation before ending the session.

Reiki

Holistic Education OTHER

The psychoeducational intervention will be presented in a traditional classroom format with weekly one hour meetings taking place during the six week study period. Each class meeting will address specific aspects of CIPN. Participants will be presented with content related to basic neuroanatomy, physiology, the effects of chemotherapy on peripheral nervous system, how available allopathic treatments (pharmacological/psychopharmacological) can be helpful, and psychosocial issues related to CIPN. The final week of the psychoeducational group will include the identification of complementary interventions that may be of help to people living with CIPN.

Holistic Education

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• participants must be of at least 18 years of age,
• participants must have persistent symptoms of CIPN resulting from treatment with vinca alkaloid, taxane, platinum class chemotherapies or immunomodulators (Thalidomide) or antineoplastic agents (Velcade) for a known cancer diagnosis
• participants must have completed chemotherapy at least three months prior to beginning the study,
• participants cannot concurrently receive chemotherapy treatment for cancer, nor
• actively take part in one of the complementary modalities offered in this pilot study.
• participants will be required to have an ability to comfortably speak, read, and understand English.
• participants must be fully oriented and possess the capacity to understand and provide informed consent for participation in the study.

Sponsors & Collaborators

• George Mason University: lead

Study Sites (1)

Life with Cancer Family Center

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neoplasms

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Paul G Clark, PhD

  George Mason University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 3, 2012
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: March 1, 2012
• Last Updated: April 3, 2012

Record last verified: 2012-04

Locations

US (1)