The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:
* Is it feasible to conduct this program? * Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?
Currently living in the United States
Aged 18 years or older
Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)
Treating prescribing provider who follows regularly with participant
<1 month since initial diagnosis and/or <1 month since surgical resection
Enrollment in hospice
Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed
Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)
Parallel
Group Self-Management Sessions
BehavioralOur targeted self-management intervention will be delivered virtually through eight 90-minute sessions over a 3-4-month period using materials adapted from previous focus groups of people with brain cancer and an expert design panel. A nurse educator and peer educator will facilitate the virtual sessions. The content covers topics focused on how to improve the quality of life in people diagnosed with brain cancer.
Educational Materials Only
Other interventionSelf-management content specifically designed for people with brain cancer will be uploaded into a learning management system. The content will be broken up into modules that will be unlocked at the same frequency as the self-management group sessions arm. There are no group sessions involved, and there are no nurse or peer educators to lead the participants through this content.
Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)
Evaluated by the change overall score of the RAND 36-Item Short Form Survey Instrument (SF-36) at baseline, immediate after intervention, and 3 months post-intervention
Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress
Change from Baseline to immediately after intervention in score of NIH Toolbox Item Bank v3.0 - Percevied Stress (Ages 18+) - Fixed Form
Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Change from baseline to immediately post-intervention in score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being
Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression
Change from baseline to immediately post-intervention of score from the Neuro-QOL Item Bank v1.0 - Depression survey
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form
Change from baseline to immediately post-intervention in score from Neuro-QOL Item Bank v1.0 Fatigue - Short Form survey
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
University Hospitals Cleveland Medical Center
Collaborator
U.S. Army Medical Research and Development Command
Collaborator
Case Western Reserve University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
