Malignant NeoplasmNCT03445572
Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer
A study testing Best Practice, Meditation Therapy and Questionnaire Administration in people with Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Best Practice, Meditation Therapy and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2018to 4 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Patients with ESAS > 4/10 on dyspnea
- Patients requiring oxygen more than 2 liters
- Patients who are current meditation practitioners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Meditative Practices in Hospitalized Cancer Patients
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Test the feasibility of the meditation practice.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Malignant Neoplasm
- Being tested
- Best Practice, Meditation Therapy, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard supportive care
Meditation TherapyProcedure or surgery
Also called Meditation
Perform MSB
Meditation TherapyProcedure or surgery
Also called Meditation
Perform IK meditation
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (MSB) | Experimental | Participants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days. Receives: Procedure: Meditation Therapy; Other: Questionnaire Administration |
| 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. Receives: Procedure: Meditation Therapy; Other: Questionnaire Administration |
| 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. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Meditation Practice defined by Recruitment Rate
Measured: Day 7
Feasibility of the Meditation Practice defined by Adherence Rate
Measured: Day 7
Secondary outcomes (2)
Acceptability of Meditation in Cancer Patients Assessed by Modified Global Symptom Evaluation (GSE)
Measured: 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.
Measured: Enrollment and a weekly basis until the end of study at four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start21 Sep 2018
- Primary completion4 Aug 2020
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Santhosshi Narayanan, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445572
- Sponsor's protocol ID
- 2017-0694
- Other IDs
- NCI-2018-00927, 2017-0694, P30CA016672
- Status last verified
- Aug 2020
- First submitted
- 19 Feb 2018
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32153208
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Meditative Practices in Hospitalized Cancer Patients
- ClinicalTrials.gov ID
- NCT03445572
- Acronym / sponsor ID
- 2017-0694
- Conditions
- Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Test the feasibility of the meditation practice.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (MSB) | Experimental | Procedure: Meditation Therapy, Other: Questionnaire AdministrationParticipants are instructed on the MSB technique and then perform MSB over 15 minutes BID for 28 days. |
| Group II (IK meditation) | Experimental | Procedure: Meditation Therapy, Other: Questionnaire AdministrationParticipants are instructed on the 3 steps of IK meditation and then perform IK meditation over 15 minutes BID for 28 days. |
| Group III (waitlist) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationParticipants are placed on a waitlist and receive standard supportive care for 28 days. After 28 days, participants may crossover to Group II. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard supportive care | Other | Group III (waitlist) |
| Meditation TherapyAlso: MeditationPerform MSB | Procedure or surgery | Group I (MSB) |
| Meditation TherapyAlso: MeditationPerform IK meditation | Procedure or surgery | Group II (IK meditation) |
| Questionnaire AdministrationAncillary studies | Other | Group I (MSB), Group II (IK meditation), Group III (waitlist) |
Primary outcome
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
2 secondary outcomes
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)
Time frame: Enrollment and a weekly basis until the end of study at four weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Derived from this study: PubMed 32153208Narayanan 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santhosshi Narayanan principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Meditation Therapy and Questionnaire Administration in people with Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Meditation Practice defined by Recruitment Rate (time frame: Day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.