An interventional study of Group Self-Management Sessions and Educational Materials Only in Brain Cancer, sponsored by University of Colorado, Denver. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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:
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 64 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants in the intervention arm will attend eight 90-minute virtual group sessions with nurse and peer educators that will navigate them through the different self-management content.
Behavioral: Group Self-Management Sessions
Participants in this arm will be invited to use an online learning management system to access the educational materials. There are no group sessions, and there are no nurse or peer educators that will lead the participants through the materials.
Other: Educational Materials Only
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.
Also known as: Self-management intervention
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.
Also known as: Content only
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
Time frame: Baseline, immediately post-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
Time frame: Baseline and immediately post-intervention
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
Time frame: Baseline and immediately post-intervention
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
Time frame: Baseline and immediately post-intervention
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
Time frame: Baseline and immediately post-intervention
Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function
Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys
Time frame: Baseline
Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form
Baseline overall score from the Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form surveys
Time frame: Baseline
Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form
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
Time frame: Baseline and immediately post-intervention
Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form
Change in score from baseline to immediately post-intervention from the Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form survey
Time frame: Baseline and immediately post-intervention
Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a
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
Time frame: Baseline and immediately post-intervention
Survival
Self/contact-reported survival
Time frame: Immediate post-intervention, 3 months post-intervention
Plan to share: No — The datasets generated during and/or analyzed during the current study will not be publicly available, but will be available from the primary investigator on reasonable request.
Started Jun 2026 (actual). Primary completion is estimated for Oct 2027, 16 months after the start.
Of 306 non-industry interventional studies with no phase under Brain Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 125. This study's planned 16 months is below that.
Counting every sponsor, half of 317 studies reached it within 64 months; a quarter within 35 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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