Effects of Reiki, Yoga, Meditation, on the Physical and Psychological Symptoms of Chemotherapy-Induced Peripheral Neuropathy
- Conditions
- Peripheral Neuropathy
- Interventions
- Behavioral: Yoga InterventionBehavioral: Meditation InterventionBehavioral: ReikiOther: Holistic Education
- Registration Number
- NCT01569269
- Lead Sponsor
- George Mason University
- 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.
- Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) is a side effect that occurs with many of the most common chemotherapeutic agents used to treat cancer. Typically, CIPN is experienced as tingling, burning, numbness, or pain in the upper and lower extremities and other parts of the body. Severity of symptoms can range from bothersome to disabling and can have profoundly negative effects on quality of life. Although the specific incidence or prevalence of CIPN is unknown, it is generally estimated at 30 to 40 percent in patients who have received the classes of chemotherapeutic agents used to treat breast, colon, and lung, cancers, and lymphomas. There are no treatments or drugs that consistently ameliorate or lead to the reversal of CIPN symptoms.Typically, symptoms of CIPN are considered along with other pain symptoms and treated with opioids and analgesics. Additionally, the prescription of anticonvulsant medications and tricyclic antidepressants can help alleviate neuropathic pain. While these strategies can provide relief from cancer-related pain, they often yield limited results for symptoms of CIPN. With few allopathic treatment alternatives for attenuating the symptoms of CIPN, people living with these symptoms have few options other than to endure them.
Unlike treatments based upon nociceptive and neuropathic models of pain that regard the pain response as the outcome of a finite and mechanistic chain of biochemical events, complementary treatments acknowledge the interpenetrating nature of the relationships between body, mind, and spirit. Typically, complementary or integrative health strategies incorporate psychological, emotional, and spiritual elements along with biochemical strategies when addressing pain. Of particular interest in the proposed pilot study are complementary techniques that include Yoga, Meditation, and Reiki.
Utilizing a pretest-posttest control group design with random assignment, this four-arm experimental pilot study will be undertaken to determine the feasibility of three complementary approaches in reducing the signs and symptoms of CIPN. This design was chosen for its ability to support causal inference while managing threats to internal and external design validity. The use of random assignment in the development of intervention and comparison groups will strengthen the ability of this design to manage threats to internal validity more efficiently. This pilot study involves the collection of quantitative data from self-administered instruments that have been designed to measure health related quality of life, symptoms of neurotoxicity, psychological distress, and mindfulness.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- 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.
- failure to meet any one of the inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Yoga Yoga Intervention See intervention description Meditation Meditation Intervention See intervention description Reiki Reiki see intervention description Holistic Education Holistic Education see intervention description
- Primary Outcome Measures
Name Time Method FACT GOG-ntx scale change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks 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.
- Secondary Outcome Measures
Name Time Method The Brief Symptom Inventory - 18 (BSI-18) change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks The BSI-18 is an 18-item brief psychological screening instrument that has been designed to measure distress and yields a global distress score as well as subscale scores for somatic concerns, anxiety, and depression. The BSI-18 has been found to have good internal reliability with a Cronbach's alpha value of 0.89
Mindful Attention Awareness scale (MAAS) change from baseline in quality of life and symptoms of neurotoxicity in 6 weeks The MAAS is a 15-item scale that is self-administered, requires no assistance to complete, and can be taken in five minutes or less. The instrument was developed to evaluate states of mindfulness or the respondent's capacity to simply observe and be aware of internal and external events in the present moment as a method of self-regulation. Internal reliability of items on the MAAS has been established with Cronbach's Alpha coefficients at 0.80 or higher per item.
Trial Locations
- Locations (1)
Life with Cancer Family Center
🇺🇸Fairfax, Virginia, United States