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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-21

Study Completion Date

2020-08-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Meditation Therapy

Intervention Type PROCEDURE

Perform MSB

Questionnaire Administration

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Meditation Therapy

Intervention Type PROCEDURE

Perform IK meditation

Questionnaire Administration

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard supportive care

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard supportive care

Intervention Type OTHER

Meditation Therapy

Perform MSB

Intervention Type PROCEDURE

Meditation Therapy

Perform IK meditation

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Meditation Meditation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 32153208 (View on PubMed)

Related Links

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http://www.mdanderson.org

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

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0694

Identifier Type: -

Identifier Source: org_study_id

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