Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer
- Conditions
- Malignant Neoplasm
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
- 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
M D Anderson Cancer Center🇺🇸Houston, Texas, United States