Clinical trial NCT03915912: Mindfulness Meditation in Glioma Patients
Official title: A Feasibility Study of Mindfulness Meditation Practice in Malignant Glioma Patients Throughout Standard of Care Chemoradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Glioma
Keywords: Malignant Glioma
Mindfulness
Dina Randazzo
Meditation
Katherine Barnett Peters
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Cancer Institute
First posted: 2019-04-16
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability: Number of sessions that the patient attends
timeFrame: 6 weeks
measure: 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?'
timeFrame: 6 weeks
measure: Acceptability: Percentage of patients who intend to continue meditation after study completion
timeFrame: 6 weeks
measure: Acceptability: Percentage of patients who continued meditation practice during the 2 months after study completion
timeFrame: 4 months
measure: Demand: Total time required to enroll 15 patients
timeFrame: 2 years
measure: Demand: Percentage of patients who enroll in the study
timeFrame: 2 years
measure: Implementation: Percentage of patients who complete the study questionnaires
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Katherine B Peters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: