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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02170350
• Other study ID #: 14D.272
• Secondary ID: 2013-107
• Status: Terminated
• Phase: N/A
• Start date: June 6, 2014
• Est. completion date: August 18, 2016

Study information

• Verified date: May 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: August 18, 2016
• Est. primary completion date: July 9, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Meditation therapy
Use brief mindful meditation practice

Other:
• Quality-of-life assessment
Ancillary studies
• Questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

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