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Completed

NCT Number: NCT03445572

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive standard supportive care

Other names: standard of care, standard therapy

Meditation Therapy

Procedure

Perform MSB

Other names: Meditation

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility of the Meditation Practice defined by Recruitment Rate

    Time frame: Day 7

  2. Feasibility of the Meditation Practice defined by Adherence Rate

    Time frame: Day 7

Secondary outcomes

  1. Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE)

    Time frame: Day 7 and Day 28

  2. Effect of Meditative Practices in Cancer Patients Assessed by Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility Study of Meditative Practices in Hospitalized Cancer Patients

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2018
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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