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

Not Applicable

Completed

• Conditions: Malignant Neoplasm
• Interventions: Procedure: Meditation Therapy; Other: Best Practice; Other: Questionnaire Administration

• Registration Number: NCT03445572
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-02-19
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Study Start: 2018-09-21
• Status Verified: 2020-08
• Primary Completion: 2020-08-04
• Study Completion: 2020-08-04
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility of the Meditation Practice defined by Recruitment Rate	Day 7
Feasibility of the Meditation Practice defined by Adherence Rate	Day 7

Secondary Outcome Measures

Name	Time	Method
Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE)	Day 7 and Day 28
Effect of Meditative Practices in Cancer Patients Assessed by Edmonton Symptom Assessment Scale (ESAS)	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States