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

August 4, 2020 updated by: M.D. Anderson Cancer Center

Feasibility Study of Meditative Practices in Hospitalized Cancer Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Meditation Therapy
Perform MSB
Other Names:
  • Meditation
Procedure: Meditation Therapy
Perform IK meditation
Other Names:
  • Meditation
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Meditation Therapy
Perform MSB
Other Names:
  • Meditation
Procedure: Meditation Therapy
Perform IK meditation
Other Names:
  • Meditation
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: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard supportive care
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of the Meditation Practice defined by Recruitment Rate
Time Frame: Day 7
Day 7
Feasibility of the Meditation Practice defined by Adherence Rate
Time Frame: Day 7
Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE)
Time Frame: Day 7 and Day 28
Day 7 and Day 28
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.
Enrollment and a weekly basis until the end of study at four weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2018

Primary Completion (Actual)

August 4, 2020

Study Completion (Actual)

August 4, 2020

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0694 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2018-00927 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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