Clinical trial NCT03445572: Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer
Official title: Feasibility Study of Meditative Practices in Hospitalized Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-02-26
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Meditation Practice defined by Recruitment Rate
timeFrame: Day 7
measure: Feasibility of the Meditation Practice defined by Adherence Rate
timeFrame: Day 7
Secondary outcomes:
measure: Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE)
timeFrame: Day 7 and Day 28
measure: Effect of Meditative Practices in Cancer Patients Assessed by Edmonton Symptom Assessment Scale (ESAS)
timeFrame: Enrollment and a weekly basis until the end of study at four weeks.
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Santhosshi Narayanan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.