Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer
NCT ID: NCT03445572
Last Updated: 2020-08-06
Study Results
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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COMPLETED
NA
41 participants
INTERVENTIONAL
2018-09-21
2020-08-04
Brief Summary
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Detailed Description
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I. Test the feasibility of the meditation practice.
SECONDARY OBJECTIVES:
I. Explore the acceptability of meditation in cancer patients through modified Global Symptom Evaluation (GSE) and on day 7 +/- 1 day and day 28 +/- 3 days.
II. Explore the effect of meditative practices in cancer patients through Edmonton Symptom Assessment Scale (ESAS) on the day of enrolment and a weekly basis until the end of study at four weeks.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I (MSB): Participants are instructed on the meditative slow breathing (MSB) technique and then perform MSB over 15 minutes twice daily (BID) for 28 days.
GROUP II (IK MEDITATION): Participants are instructed on the 3 steps of Isha Kriya (IK) meditation and then perform IK meditation over 15 minutes BID for 28 days.
GROUP III (WAITLIST): Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (MSB)
Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days.
Meditation Therapy
Perform MSB
Questionnaire Administration
Ancillary studies
Group II (IK meditation)
Participants are instructed on the 3 steps of IK meditation and then perform IK meditation over 15 minutes BID for 28 days.
Meditation Therapy
Perform IK meditation
Questionnaire Administration
Ancillary studies
Group III (waitlist)
Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.
Best Practice
Receive standard supportive care
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive standard supportive care
Meditation Therapy
Perform MSB
Meditation Therapy
Perform IK meditation
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted to the hospital
* Able to follow instructions
* Eastern Cooperative Oncology Practice (Eastern Cooperative Oncology Group \[ECOG\]) score of 3 or below
* Fluency in English
Exclusion Criteria
* Patients with cognitive dysfunction
* Patients who are admitted for observation for \< 48 hours will be excluded from the study, as one day would be difficult to provide the necessary information
* Patients who are delirious
* Patients who are unable to follow instructions due to their medical condition
* Patients admitted to the intensive care unit
* Patients with ESAS \> 4/10 on dyspnea
* Patients requiring oxygen more than 2 liters
* Patients who are current meditation practitioners
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Santhosshi Narayanan
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Narayanan S, Reddy A, Lopez G, Liu W, Wu J, Liu D, Manzano J, Williams JL, Mallaiah S, George M, Amaram J, Subramaniam B, Cohen L, Bruera E. Randomized Feasibility Study of Meditative Practices in Hospitalized Cancer Patients. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420909903. doi: 10.1177/1534735420909903.
Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-00927
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0694
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0694
Identifier Type: -
Identifier Source: org_study_id
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