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Trial record 9 of 100 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Texas, United States ) | NIH, U.S. Fed

Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress

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ClinicalTrials.gov Identifier: NCT02988271
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This trial studies how well self-administered meditation therapy works in improving anxiety and depression in cancer patients who exhibit psychosocial distress. Meditation therapy is a mind-body approach that uses a variety of techniques, such as deep breathing, sound, or movement, that may help to decrease distress and anxiety and enhance the health and quality of life of patients with cancer.

Condition or disease Intervention/treatment Phase
Anxiety Depression Malignant Neoplasm Other: Interview Procedure: Meditation Therapy Procedure: Quality-of-Life Assessment Procedure: Supportive Care Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Self-Administered Meditation Intervention for Cancer Patients With Psychosocial Distress
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 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.
Other: Interview
Participate in interview

Procedure: Meditation Therapy
Complete meditation therapy
Other Name: Meditation

Procedure: Quality-of-Life Assessment
Complete questionnaires
Other Name: Quality of Life Assessment

Active Comparator: 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.
Other: Interview
Participate in interview

Procedure: Quality-of-Life Assessment
Complete questionnaires
Other Name: Quality of Life Assessment

Procedure: Supportive Care
Receive supportive care
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive




Primary Outcome Measures :
  1. Feasibility of self-administered meditation [ Time Frame: Up to 2 weeks ]
    Feasibility will be confirmed if at least 50% of the eligible patients approached consent to the study and at least 70% of subjects complete at least two meditation sessions each week during the 2-week period. The study will calculate rates, frequencies, and 90% confidence intervals (CIs) of the rates.


Secondary Outcome Measures :
  1. Self-administered meditation effect on anxiety and depression as measured by the Edmonton Symptom Assessment Scale (ESAS) questionnaire [ Time Frame: Up to 2 weeks ]
    Summary statistics and 90% CIs will be calculated to assess differences in mean anxiety, depression and other outcomes measured at the end of the study, as well as the change scores from baseline, between subjects randomized to meditation and those randomized to wait-list. Additional analysis may include analysis of covariance (ANCOVA) to control for relevant baseline outcome variables or other patient characteristics. Summary statistics and 90% CIs will also be calculated separately by intervention arm and to examine within-subject differences for those who were randomized to wait-list and then received the meditation intervention.

  2. The study will evaluate participant satisfaction with the meditation delivery and tracking program using appropriate descriptive statistics. [ Time Frame: Up to 2 weeks ]
    At end of the study, specifics of the exit survey will include asking participants to identify aspects of the meditation program they liked or disliked and identify what they found most and least useful. Participants will also be asked about satisfaction with the meditation application, overall ease of use, and whether or not they would like to continue using the application if made available.

  3. Frequency of meditation and choice of length of meditation [ Time Frame: Up to 2 weeks ]
    The study will explore the association between frequency of meditation and choice of length of meditation and patient reported outcomes using correlation analyses.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at MD Anderson with a cancer history who are either undergoing active treatment or who have completed treatment for their cancer
  • 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:

  • Diagnosis of a formal thought disorder (e.g., schizophrenia)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988271


Contacts
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Contact: Gabriel Lopez, MD 713-792-5105 glopez@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gabriel Lopez-Berestein    713-792-5105      
Principal Investigator: Gabriel Lopez-Berestein         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Gabriel Lopez M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02988271     History of Changes
Other Study ID Numbers: 2016-0491
NCI-2018-01295 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0491 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders