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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Procedure: Meditation therapy
* Other: Quality-of-life assessment
* Other: Questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Patients who are receiving a course of radiation therapy for curative or adjuvant intent 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 The patient must be an adult male or female 18 or older Patient must be capable to read and speak English and provide study specific informed consent prior to study entry No prior history of radiation therapy No history of or current active drug/alcohol dependence No patients being decisionally impaired Patients who have home access to a computer, or compact disc audio player Exclusion Criteria: Patient is under the age of 18 Diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer Patient who have reported less than moderate fatigue (based on the 0-10 Fatigue scale, a fatigue score less than 5; see Appendix III) Karnofsky performance status of less than 70% within the last 60 days prior to study Prior history of radiation therapy History of or active drug/alcohol dependence or abuse Decisionally impaired patients No access to a computer, or compact disc audio player Patient who are unable to read and speak English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief mindful meditation practice<br>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. | Procedure: Meditation therapy<br>* Use brief mindful meditation practice<br>* Other names: Meditation;Other: Quality-of-life assessment<br>* Ancillary studies<br>* Other names: Quality of life assessment;Other: Questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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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 |