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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-107 | Other Identifier | CCRRC | |
| JT 5854 | Other Identifier | JeffTrial Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief mindful meditation practice | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation therapy | Procedure | Use brief mindful meditation practice |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Werner-Wasik, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Thomas Jefferson University Hospitals | View source |
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| Quality-of-life assessment | Other | Ancillary studies |
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| Questionnaire administration | Other | Ancillary studies |
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| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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