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

NCT ID: NCT02988271

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-11

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Depression Malignant Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Interview

Intervention Type OTHER

Participate in interview

Meditation Therapy

Intervention Type PROCEDURE

Complete meditation therapy

Quality-of-Life Assessment

Intervention Type PROCEDURE

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.

Group Type ACTIVE_COMPARATOR

Interview

Intervention Type OTHER

Participate in interview

Quality-of-Life Assessment

Intervention Type PROCEDURE

Complete questionnaires

Supportive Care

Intervention Type PROCEDURE

Receive supportive care

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Interview

Participate in interview

Intervention Type OTHER

Meditation Therapy

Complete meditation therapy

Intervention Type PROCEDURE

Quality-of-Life Assessment

Complete questionnaires

Intervention Type PROCEDURE

Supportive Care

Receive supportive care

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Meditation Quality of Life Assessment Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gabriel Lopez

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2018-01295

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-0491

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-0491

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.