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

Not Applicable

Terminated

• Conditions: Malignant Neoplasm
• Interventions: Procedure: Meditation therapy; Other: Quality-of-life assessment; Other: Questionnaire administration

• Registration Number: NCT02170350
• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Brief 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.

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 Timeline

• Study Start: 2014-06-06
• Study First Submitted: 2014-06-19
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Primary Completion: 2015-07-09
• Study Completion: 2016-08-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Brief mindful meditation practice	Quality-of-life assessment	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.
Brief mindful meditation practice	Meditation therapy	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.
Brief mindful meditation practice	Questionnaire administration	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.

Primary Outcome Measures

Name	Time	Method
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	Up to 12 weeks after completion of radiation therapy	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States