Mindfulness Meditation in Glioma Patients

NCT ID: NCT03915912

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2020-01-09

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.

Conditions

Malignant Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness meditation

Intervention Type: BEHAVIORAL

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.

Interventions

Mindfulness meditation

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke Cancer Institute

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine B Peters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Related Links

https://tischbraintumorcenter.duke.edu/

The Preston Robert Tisch Brain Tumor Center at Duke

http://www.dukecancerinstitute.org/

Duke Cancer Institute

Other Identifiers

Pro00101218

Identifier Type: -

Identifier Source: org_study_id