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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Terminated

Conditions: Malignant Neoplasm

Treatments: Procedure: Meditation therapy; Other: Questionnaire administration; Other: Quality-of-life assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT02170350

14D.272

2013-107 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Brief mindful meditation practice

Experimental group

Description:

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.

Treatment:

Other: Quality-of-life assessment

Other: Questionnaire administration

Procedure: Meditation therapy