- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03915912
Mindfulness Meditation in Glioma Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 18 years of age
- NCCN distress scale ≥ 4 OR at least one of the following problems indicated on the NCCN distress thermometer worksheet: depression, fears, nervousness, sadness, worry, loss of interest in usual activities, sleep, memory, or fatigue
- Karnofsky Performance Status (KPS) ≥ 70
- Patient must have histologically confirmed, newly diagnosed WHO grade III or IV malignant glioma
- Patient must be prior to a planned 6-week standard of care chemoradiation regimen
- Patient can speak, read, and write English
- Patient has access to a telephone for mindfulness training
- Patient has access to internet
Exclusion Criteria:
- Patients previously or currently practicing or participating in mindfulness meditation practice
- Intermittent or active psychosis
- Psychiatric hospitalization within the last 6 months
- Hospitalized in a rehab facility within the last 6 months for substance abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness meditation
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.
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The study intervention consists of seven mindfulness sessions (six 1-hour telephone sessions and one 1-hour in-person session).
The six weekly telephone-based mindfulness sessions will occur in a one-on-one format and will be followed by one in-person, one-on-one session, which will occur at the post-chemoradiation standard of care clinic visit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability: Number of sessions that the patient attends
Time Frame: 6 weeks
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One measure of the acceptability of the mindfulness intervention is the number of sessions the patient attended.
The number of patients who attend at least 3 of the 6 telephone-based mindfulness session in addition to the in-person session is reported.
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6 weeks
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Acceptability: Patients' satisfaction with the mindfulness sessions: The number of patients that respond either 'somewhat satisfied,' 'mostly satisfied,' or 'very satisfied' to the question 'How satisfied are you with the mindfulness sessions?'
Time Frame: 6 weeks
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One measure of the acceptability of the mindfulness intervention is the extent of satisfaction patients have with the mindfulness sessions.
The number of patients that respond either 'somewhat satisfied,' 'mostly satisfied,' or 'very satisfied' to the question 'How satisfied are you with the mindfulness sessions?' on the exit survey is reported.
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6 weeks
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Acceptability: Percentage of patients who intend to continue meditation after study completion
Time Frame: 6 weeks
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One measure of the acceptability of the mindfulness intervention is the intent to continue practicing mindfulness meditation following study completion.
The percentage of patients who respond 'yes' to the question 'Do you plan on continuing to practice mindfulness meditation?' on the 6-week exit survey is reported.
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6 weeks
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Acceptability: Percentage of patients who continued meditation practice during the 2 months after study completion
Time Frame: 4 months
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One measure of the acceptability of the mindfulness intervention is the percentage of patients that continued mindfulness meditation during the 2 months following the intervention as measured by question 'Did you continue your meditation practice after the training sessions?' captured on the final exit survey given 4 months after study initiation, which is 2 months after completing the mindfulness intervention.
The percentage of patients responding 'yes' to this question is reported.
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4 months
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Demand: Total time required to enroll 15 patients
Time Frame: 2 years
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One measure of the demand of the mindfulness intervention is the length of time required to enroll 15 patients.
The length of time in months needed to enroll 15 patients is reported.
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2 years
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Demand: Percentage of patients who enroll in the study
Time Frame: 2 years
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One measure of the demand of the mindfulness intervention is the percentage of patients enrolling in the study of those to which the study is offered.
This percentage is reported.
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2 years
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Implementation: Percentage of patients who complete the study questionnaires
Time Frame: 4 months
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Implementation of the mindfulness intervention is measured by the percentage of patients who complete the study questionnaires measuring quality of life and evaluation of the mindfulness intervention at each time point of the study.
Questionnaires are completed at baseline during screening, approximately 6 weeks post-baseline at the in-person mindfulness session, and 4 months post-baseline at the follow-up final exit survey.
The percentage of patients who completed all questionnaires at each study time point is reported.
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4 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine B Peters, MD, PhD, Duke University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00101218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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