Mindfulness Meditation in Glioma Patients
Mindfulness Meditation in Glioma Patients
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.
Inclusion Criteria:

 1. ≥ 18 years of age

 2. 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

 3. Karnofsky Performance Status (KPS) ≥ 70

 4. Patient must have histologically confirmed, newly diagnosed WHO grade III or IV
 malignant glioma

 5. Patient must be prior to a planned 6-week standard of care chemoradiation regimen

 6. Patient can speak, read, and write English

 7. Patient has access to a telephone for mindfulness training

 8. Patient has access to internet

 Exclusion Criteria:

 1. Patients previously or currently practicing or participating in mindfulness meditation
 practice

 2. Intermittent or active psychosis

 3. Psychiatric hospitalization within the last 6 months

 4. Hospitalized in a rehab facility within the last 6 months for substance abuse