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

NCT02988271 | Active Not Recruiting

• 3 other identifiers: 2016-0491NCI-2018-01295P30CA016672
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to 2 weeks

• The study will evaluate participant satisfaction with the meditation delivery and tracking program using appropriate descriptive statistics.

  Up to 2 weeks

• Frequency of meditation and choice of length of meditation

  Up to 2 weeks

Study Arms (2)

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.

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.

Other: Interview; Procedure: Quality-of-Life Assessment; Procedure: Supportive Care

Interventions

Interview OTHER

Participate in interview

Group I (meditation); Group II (waitlist control)

Meditation Therapy PROCEDURE

Complete meditation therapy

Also known as: Meditation

Group I (meditation)

Supportive Care PROCEDURE

Receive supportive care

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Group II (waitlist control)

Quality-of-Life Assessment PROCEDURE

Complete questionnaires

Also known as: Quality of Life Assessment

Group I (meditation); Group II (waitlist control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Anxiety Disorders; Depression; Neoplasms

Interventions

Interviews as Topic; Meditation; Palliative Care

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gabriel Lopez

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: April 11, 2019
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)