Brief Mindful Meditation Practice in Improving Quality of Life in Patients With Cancer Undergoing Radiation Therapy

NCT ID: NCT02170350

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-06
• Study Completion Date: 2016-08-18

Brief Summary

This pilot clinical trial studies how well brief mindful mediation practice works in improving quality of life in patients with cancer undergoing radiation therapy. Brief mindful mediation practice may improve the well-being and quality of life of patients with cancer who are undergoing radiation therapy by increasing levels of mindfulness and reducing stress, anxiety/depression, and fatigue.

Detailed Description

PRIMARY OBJECTIVES:

I. To investigate the feasibility of a clinical trial using a brief mindful meditation practice during radiation therapy.

SECONDARY OBJECTIVES:

I. To explore the measurable changes in quality of life, fatigue, and mindfulness while using a brief mindful meditation practice during radiation therapy.

OUTLINE:

Patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy.

After completion of study, patients are followed up 4-12 weeks after completion of radiation therapy.

Conditions

Malignant Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Brief mindful meditation practice

Patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy.

Group Type: EXPERIMENTAL

Meditation therapy

Intervention Type: PROCEDURE

Use brief mindful meditation practice

Quality-of-life assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

Meditation therapy

Use brief mindful meditation practice

Intervention Type: PROCEDURE

Quality-of-life assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Meditation; Quality of life assessment

Eligibility Criteria

Inclusion Criteria

1. Pathologically proven diagnosis of cancer any stage, based upon the following minimum diagnostic workup: History & physical examination, including documentation of Karnofsky Performance Status of 70 - 100% for at least 60 days prior to study entry

2. Patients who are receiving a course of radiation therapy for curative or adjuvant intent

3. Patient who have reported fatigue moderate or higher fatigue (based on the 0-10 Fatigue scale, a fatigue score of 5 or; see Appendix III) while on radiation treatment

4. The patient must be an adult male or female 18 or older

5. Patient must be capable to read and speak English and provide study specific informed consent prior to study entry

6. No prior history of radiation therapy

7. No history of or current active drug/alcohol dependence

8. No patients being decisionally impaired

9. Patients who have home access to a computer, or compact disc audio player

Exclusion Criteria

1. Patient is under the age of 18

2. Diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer

3. Patient who have reported less than moderate fatigue (based on the 0-10 Fatigue scale, a fatigue score less than 5; see Appendix III)

4. Karnofsky performance status of less than 70% within the last 60 days prior to study

5. Prior history of radiation therapy

6. History of or active drug/alcohol dependence or abuse

7. Decisionally impaired patients

8. No access to a computer, or compact disc audio player

9. Patient who are unable to read and speak English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Werner-Wasik, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

Related Links

http://www.JeffersonHospital.org

Thomas Jefferson University Hospitals

Other Identifiers

2013-107

Identifier Type: OTHER

Identifier Source: secondary_id

JT 5854

Identifier Type: OTHER

Identifier Source: secondary_id

14D.272

Identifier Type: -

Identifier Source: org_study_id