Mindfulness Meditation in Glioma Patients

NCT03915912 | Completed

• 1 other identifier: Pro00101218
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Glioma

Keywords

Malignant Glioma; Mindfulness; Dina Randazzo; Meditation; Katherine Barnett Peters

Outcome Measures

Primary Outcomes (7)

• Acceptability: Number of sessions that the patient attends

  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.

  6 weeks

• 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?'

  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.

  6 weeks

• Acceptability: Percentage of patients who intend to continue meditation after study completion

  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.

  6 weeks

• Acceptability: Percentage of patients who continued meditation practice during the 2 months after study completion

  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.

  4 months

• Demand: Total time required to enroll 15 patients

  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.

  2 years

• Demand: Percentage of patients who enroll in the study

  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.

  2 years

• Implementation: Percentage of patients who complete the study questionnaires

  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.

  4 months

Study Arms (1)

Mindfulness meditation

EXPERIMENTAL

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.

Behavioral: Mindfulness meditation

Interventions

Mindfulness meditation 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.

Mindfulness meditation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Duke Cancer Institute: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Tumor Center at Duke
• Duke Cancer Institute

MeSH Terms

Conditions

Glioma

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Katherine B Peters, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: April 11, 2019
• Primary Completion: January 9, 2020
• Study Completion: January 9, 2020
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)