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

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)

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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