An interventional study of Best Practice and Meditation Therapy in Malignant Neoplasm, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-06.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days.
Procedure: Meditation Therapy · Other: Questionnaire Administration
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
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
Receive standard supportive care
Also known as: standard of care, standard therapy
Perform MSB
Also known as: Meditation
Perform IK meditation
Also known as: Meditation
Ancillary studies
Feasibility of the Meditation Practice defined by Recruitment Rate
Time frame: Day 7
Feasibility of the Meditation Practice defined by Adherence Rate
Time frame: Day 7
Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE)
Time frame: Day 7 and Day 28
Effect of Meditative Practices in Cancer Patients Assessed by Edmonton Symptom Assessment Scale (ESAS)
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.
Time frame: Enrollment and a weekly basis until the end of study at four weeks.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center