AnxietyNCT02988271
Meditation Therapy in Improving Anxiety and Depression in Cancer Patients With Psychosocial Distress
A study testing Interview, Meditation Therapy and Quality-of-Life Assessment in people with Anxiety and Depression, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Malignant Neoplasm
- What is being tested?
- Interview, Meditation Therapy and Quality-of-Life Assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Administered Meditation Intervention for Cancer Patients With Psychosocial Distress
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of having patients self-administer meditation recordings using a portable, computer-based program during a 2-week period.
SECONDARY OBJECTIVES:
- 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
- Anxiety, Depression, Malignant Neoplasm
- Being tested
- Interview, Meditation Therapy, Quality-of-Life Assessment, Supportive Care
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participate in interview
Meditation TherapyProcedure or surgery
Also called Meditation
Complete meditation therapy
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Complete questionnaires
Supportive CareProcedure or surgery
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive supportive care
| Study group | Role | What they receive |
|---|---|---|
| Group I (meditation) | Experimental | 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. Receives: Other: Interview; Procedure: Meditation Therapy; Procedure: Quality-of-Life Assessment |
| Group II (waitlist control) | Active comparator | 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. Receives: Other: Interview; Procedure: Quality-of-Life Assessment; Procedure: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of self-administered meditation
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.
Measured: Up to 2 weeks
Secondary outcomes (3)
Self-administered meditation effect on anxiety and depression as measured by the Edmonton Symptom Assessment Scale (ESAS) questionnaire
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.
Measured: Up to 2 weeks
The study will evaluate participant satisfaction with the meditation delivery and tracking program using appropriate descriptive statistics.
The questionnaire purpose is to learn more about meditation's effect on your health over the past two weeks. It asks, how much do you agree or disagree? Options are, strongly disagree, disagree, neutral, agree and strongly agree. The questionnaire asks patients to pick the closest answer for each statement. The first statements asks, 'My well-being has improved', the second, "I am more focused', the third asks, 'I am in a better mood', the fourth asks, 'My energy level had increased', and lastly, 'I am sleeping better'. The exit questionnaire is scored as a sum value for each scale range provided. For each scale range provided, higher values/and or lower values represent whether participants agree or disagree with the statements listed.
Measured: Up to 2 weeks
Frequency of meditation and choice of length of meditation
The study will explore the association between frequency of meditation and choice of length of meditation and patient reported outcomes using correlation analyses.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start11 Apr 2019
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- 35 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
- Gabriel Lopez, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988271
- Sponsor's protocol ID
- 2016-0491
- Other IDs
- NCI-2018-01295, 2016-0491, P30CA016672
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2016
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered Meditation Intervention for Cancer Patients With Psychosocial Distress
- ClinicalTrials.gov ID
- NCT02988271
- Acronym / sponsor ID
- 2016-0491
- Conditions
- Anxiety, Depression, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- 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 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.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of having patients self-administer meditation recordings using a portable, computer-based program during a 2-week period.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (meditation) | Experimental | Other: Interview, Procedure: Meditation Therapy, Procedure: Quality-of-Life AssessmentPatients 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. |
| Group II (waitlist control) | Active comparator | Other: Interview, Procedure: Quality-of-Life Assessment, Procedure: Supportive CarePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| InterviewParticipate in interview | Other | Group I (meditation), Group II (waitlist control) |
| Meditation TherapyAlso: MeditationComplete meditation therapy | Procedure or surgery | Group I (meditation) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentComplete questionnaires | Procedure or surgery | Group I (meditation), Group II (waitlist control) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive supportive care | Procedure or surgery | Group II (waitlist control) |
Primary outcome
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.
3 secondary outcomes
Self-administered meditation effect on anxiety and depression as measured by the Edmonton Symptom Assessment Scale (ESAS) questionnaire
Time frame: Up to 2 weeks
The study will evaluate participant satisfaction with the meditation delivery and tracking program using appropriate descriptive statistics.
Time frame: Up to 2 weeks
Frequency of meditation and choice of length of meditation
Time frame: Up to 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- 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.
Gabriel Lopez 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 Interview, Meditation Therapy and Quality-of-Life Assessment in people with Anxiety and Depression, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 self-administered meditation (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.