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A Feasibility Study of Mindfulness Meditation Practice in Malignant Glioma Patients Throughout Standard of Care Chemoradiation
This pilot study is designed to determine the feasibility of providing a mindfulness meditation program to patients with newly diagnosed malignant glioma during standard of care chemoradiation. Newly diagnosed malignant glioma patients will participate in six 1-hour mindfulness sessions over the phone, followed by one 1-hour in-person mindfulness session. Patients will complete various Quality of Life questionnaires and distress measuring tools prior to initiating the mindfulness sessions, at the clinic visit following the mindfulness intervention, and \~2 months after completing the mindfulness intervention. Additionally, patients will be provided with supplemental materials including website references and guided audiotape meditations to guide their individual practice outside of the weekly guided sessions. The main objective of this study is to assess the feasibility of a mindfulness meditation intervention program, designed to mitigate the distress associated with the disease and first line treatment of patients with malignant glioma, and to determine whether it merits additional research in a subsequent trial. There are no risks associated with participation in this study.
Fifteen newly diagnosed WHO grade III or IV malignant glioma patients will be enrolled to this pilot feasibility study. Following completion of informed consent, patients will complete a baseline assessment consisting of various QoL/distress assessments including the Trail Making Test, the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), the Pittsburgh Sleep Quality Index (PSQI), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy-Brain (FACT-Br), the Five Facet Mindfulness Questionnaire - short form (FFMQ-SF), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp12), the NCCN Distress Thermometer with Symptom Inventory, and the Hospital Anxiety and Depression Scale (HADS). They will then begin the mindfulness intervention, consisting of six weekly telephone-based mindfulness sessions followed by one in-person mindfulness session. Post-treatment measures and an Exit Survey will be administered following the one in-person mindfulness session. Two months later, the QoL, cognition and distress assessments will be repeated and a Final Exit Survey will be administered. The Exit Survey will ask the patient about their individual mindfulness practice during the intervention, their intention to continue the practice beyond participation in this study, their satisfaction with the services received, and their perception of the effectiveness of the program. The Final Exit Survey will ask the patient about their mindfulness practice since the Exit Survey, and their intention to continue with the mindfulness practice. The investigators will also collect demographic data such as age, marital status, education, employment, date of diagnosis and death, tumor grade, histology, and type of treatment from the patient.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Duke University Medical Center
Durham, North Carolina, United States
Start Date
April 11, 2019
Primary Completion Date
January 9, 2020
Completion Date
January 9, 2020
Last Updated
June 7, 2023
17
ACTUAL participants
Mindfulness meditation
BEHAVIORAL
Lead Sponsor
Duke University
Collaborators
NCT05099003
NCT05717153
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03749187