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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00927 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2017-0694 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (MSB) | Experimental | Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard supportive care |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Meditation Practice defined by Recruitment Rate | Day 7 | |
| Feasibility of the Meditation Practice defined by Adherence Rate | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santhosshi Narayanan | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32153208 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| Meditation Therapy | Procedure | Perform MSB |
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| Meditation Therapy | Procedure | Perform IK meditation |
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| Questionnaire Administration | Other | Ancillary studies |
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| Enrollment and a weekly basis until the end of study at four weeks. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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