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

Use of a Brief Mindful Meditation Practice in Adult Cancer Patients Receiving Radiation Therapy

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire administration; Procedure: Meditation therapy; Other: Quality-of-life assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Questionnaire administration; Ancillary studies; Procedure: Meditation therapy; Use brief mindful meditation practice; Other Names: Meditation; Other: Quality-of-life assessment; Ancillary studies; Other Names: Quality of life assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility measured by the proportion of patients who are adherent, defined as successful completion of the course of home base brief mindful meditation practice (at least 8 out of 14 days) and completion of questionnaires at all time points	The portion of patients who complete the brief mindful meditation practice intervention and questionnaires will be computed, along with a one-sided 95% exact confidence interval.	Up to 12 weeks after completion of radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in quality of life assessed by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	Will be analyzed using mixed-effects linear regression. Average changes and associated 95% confidence intervals will be estimated from these models.	Baseline to up to 12 weeks after completion of radiation therapy
Changes in fatigue assessed by FACIT-F	Will be analyzed using mixed-effects linear regression. Average changes and associated 95% confidence intervals will be estimated from these models.	Baseline to up to 12 weeks after completion of radiation therapy
Changes in mindfulness assessed by Freiburg Mindfulness Inventory	Will be analyzed using mixed-effects linear regression. Average changes and associated 95% confidence intervals will be estimated from these models.	Baseline to up to 12 weeks after completion of radiation therapy

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospitals
• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2014
• Primary Completion (Actual): July 9, 2015
• Study Completion (Actual): August 18, 2016

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: June 20, 2014
• First Posted (Estimate): June 23, 2014

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 14D.272; 2013-107 (Other Identifier: CCRRC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No