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

NCT02170350 | Terminated

• 3 other identifiers: 14D.2722013-107JT 5854
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Changes in fatigue assessed by FACIT-F

  Baseline to up to 12 weeks after completion of radiation therapy

• Changes in mindfulness assessed by Freiburg Mindfulness Inventory

  Baseline to up to 12 weeks after completion of radiation therapy

Study Arms (1)

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.

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

Interventions

Meditation therapy PROCEDURE

Use brief mindful meditation practice

Also known as: Meditation

Brief mindful meditation practice

Quality-of-life assessment OTHER

Ancillary studies

Also known as: Quality of life assessment

Brief mindful meditation practice

Questionnaire administration OTHER

Ancillary studies

Brief mindful meditation practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospitals

MeSH Terms

Conditions

Neoplasms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maria Werner-Wasik, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: June 6, 2014
• Primary Completion: July 9, 2015
• Study Completion: August 18, 2016
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)