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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Completed

Conditions

Malignant Neoplasm

Treatments

Procedure: Meditation Therapy
Other: Questionnaire Administration
Other: Best Practice

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03445572
NCI-2018-00927 (Registry Identifier)
P30CA016672 (U.S. NIH Grant/Contract)
2017-0694 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 3 patient groups

Group I (MSB)
Experimental group
Description:
Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days.
Treatment:
Other: Questionnaire Administration
Procedure: Meditation Therapy
Procedure: Meditation Therapy
Group II (IK meditation)
Experimental group
Description:
Participants are instructed on the 3 steps of IK meditation and then perform IK meditation over 15 minutes BID for 28 days.
Treatment:
Other: Questionnaire Administration
Procedure: Meditation Therapy
Procedure: Meditation Therapy
Group III (waitlist)
Active Comparator group
Description:
Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.
Treatment:
Other: Questionnaire Administration
Other: Best Practice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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