Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress
NCT ID: NCT02988271
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
35 participants
INTERVENTIONAL
2019-04-11
2026-02-28
Brief Summary
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Detailed Description
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I. To determine the feasibility of having patients self-administer meditation recordings using a portable, computer-based program during a 2-week period.
SECONDARY OBJECTIVES:
I. Assess the effect of self-administered meditation on anxiety, depression and other symptoms that are part of the Edmonton Symptom Assessment Scale (ESAS) questionnaire.
II. Evaluate participant satisfaction with the meditation delivery and tracking program.
III. Examine the association between the frequency of practice (number of sessions a day) and choice of length of practice (5, 10, or 15 minute sessions) and anxiety, depression and other patient reported outcomes.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (MEDITATION): Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes once daily (QD) for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.
GROUP II (WAITLIST CONTROL): Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (meditation)
Patients watch a pre-recorded instructional meditation video via an iPod meditation app. Patients then complete meditation exercises using the meditation app over 5-15 minutes QD for up to 2 weeks. Patients also complete questionnaires before and after meditation sessions and participate in an interview over 10 minutes.
Interview
Participate in interview
Meditation Therapy
Complete meditation therapy
Quality-of-Life Assessment
Complete questionnaires
Group II (waitlist control)
Patients receive supportive care, such as access to social workers, support groups, spiritual care, or other patient services for up to 2 weeks. Patients also complete questionnaires over 15-20 minutes and participate in an interview over 10 minutes.
Interview
Participate in interview
Quality-of-Life Assessment
Complete questionnaires
Supportive Care
Receive supportive care
Interventions
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Interview
Participate in interview
Meditation Therapy
Complete meditation therapy
Quality-of-Life Assessment
Complete questionnaires
Supportive Care
Receive supportive care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must understand and read English, sign a written informed consent, and follow protocol requirements
* Willing to come to MD Anderson Main Campus (Texas Medical Center) for enrollment
* Patient self-reported ESAS psychological scale score (sum of anxiety and depression scores) between 4 and 11 (and/or) individual anxiety or depression score between 4 and 7 on a 0 to 10 numeric scale, where 10 is the worst possible
* If on medication for anxiety, stable dose of medications for management of anxiety symptoms for at least six weeks prior to enrollment with no plans to change meditations in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable
Exclusion Criteria
* Known history of a neurological and/or psychological disorder that in the physician's opinion may interfere with the patient's ability to cooperate with study procedures
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gabriel Lopez
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-01295
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0491
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0491
Identifier Type: -
Identifier Source: org_study_id
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