Brain Cancer
Conditions
Keywords
Brain cancer, Glioblastoma, Astrocytoma, Ependymoma, Oligodendroglioma, Brain tumor, Mental health, Glioma, Quality of life
Brief summary
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?
Interventions
BEHAVIORALGroup Self-Management Sessions
Our 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.
Self-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.
Sponsors
University of Colorado, Denver
University Hospitals Cleveland Medical Center
U.S. Army Medical Research and Development Command
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* \<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) * Not able to communicate in English at a conversational level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36) | Baseline, immediately post-intervention, and 3 months post-intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress | Baseline and immediately post-intervention | 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 | Baseline and immediately post-intervention | 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 | Baseline and immediately post-intervention | 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 | Baseline and immediately post-intervention | Change from baseline to immediately post-intervention in score from Neuro-QOL Item Bank v1.0 Fatigue - Short Form survey |
| Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function | Baseline | Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys |
| Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form | Baseline | Baseline overall score from the Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form surveys |
| Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form | Baseline and immediately post-intervention | Change in score from baseline to immediately post-intervention of the Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activites - Short Form survey |
| Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form | Baseline and immediately post-intervention | Change in score from baseline to immediately post-intervention from the Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form survey |
| Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a | Baseline and immediately post-intervention | Change in score from baseline to immediately post-intervention from the PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a survey |
| Survival | Immediate post-intervention, 3 months post-intervention | Self/contact-reported survival |
Countries
United States
Contacts
CONTACTResearch Services Professional
PRINCIPAL_INVESTIGATORBethany M Kwan, PhD, MSPH
University of Colorado, Denver
Outcome results
None listed