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Trial record 11 of 123 for:    IK

Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03445572
Recruitment Status : Active, not recruiting
First Posted : February 26, 2018
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well meditative slow breathing or Isha Kriya meditation works in improving cancer-related symptoms in hospitalized participants with cancer. Meditative slow breathing or Isha Kriya meditation may help to decrease perceived stress and enhance well-being in hospitalized cancer participants.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Other: Best Practice Procedure: Meditation Therapy Other: Questionnaire Administration Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility Study of Meditative Practices in Hospitalized Cancer Patients
Actual Study Start Date : September 21, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Group I (MSB)
Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days.
Procedure: Meditation Therapy
Perform MSB
Other Name: Meditation

Other: Questionnaire Administration
Ancillary studies

Experimental: 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.
Procedure: Meditation Therapy
Perform IK meditation
Other Name: Meditation

Other: Questionnaire Administration
Ancillary studies

Active Comparator: 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.
Other: Best Practice
Receive standard supportive care
Other Names:
  • standard of care
  • standard therapy

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Feasibility of the Meditation Practice defined by Recruitment Rate [ Time Frame: Day 7 ]
  2. Feasibility of the Meditation Practice defined by Adherence Rate [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE) [ Time Frame: Day 7 and Day 28 ]
  2. Effect of Meditative Practices in Cancer Patients Assessed by Edmonton Symptom Assessment Scale (ESAS) [ Time Frame: Enrollment and a weekly basis until the end of study at four weeks. ]

    Scale is from 0 to 10 with 0 being no symptoms to 10 being worse symptoms.

    Proportions of participants who consider that the study makes their symptoms better estimated along with a 90% confidence interval for each of the intervention groups. The Linear mixed model used to examine the differential changes over time for ESAS scores among the three groups.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of malignancy
  • 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 life expectancy less than 2 months per attending physician or advance practice provider's note or assessment of prognosis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445572


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Santhosshi Narayanan M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03445572     History of Changes
Other Study ID Numbers: 2017-0694
NCI-2018-00927 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0694 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasms