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

NCT03445572 | Completed

• 3 other identifiers: 2017-0694NCI-2018-00927P30CA016672
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• Feasibility of the Meditation Practice defined by Recruitment Rate

  Day 7

• Feasibility of the Meditation Practice defined by Adherence Rate

  Day 7

Secondary Outcomes (2)

• 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.

Study Arms (3)

Group I (MSB)

EXPERIMENTAL

Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days.

Procedure: Meditation Therapy; Other: Questionnaire Administration

Group II (IK meditation)

EXPERIMENTAL

Participants are instructed on the 3 steps of IK meditation and then perform IK meditation over 15 minutes BID for 28 days.

Procedure: Meditation Therapy; Other: Questionnaire Administration

Group III (waitlist)

ACTIVE COMPARATOR

Participants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard supportive care

Also known as: standard of care, standard therapy

Group III (waitlist)

Meditation Therapy PROCEDURE

Perform MSB

Also known as: Meditation

Group I (MSB)

Questionnaire Administration OTHER

Ancillary studies

Group I (MSB); Group II (IK meditation); Group III (waitlist)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 32153208 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Meditation

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Santhosshi Narayanan

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: February 26, 2018
• Study Start: September 21, 2018
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

US (1)