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NCT Number: NCT07628647

Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being

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?

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Key information

Conditions

Brain Cancer Astrocytoma Behavior Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Ependymoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Oligodendroglioma Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz, Aurora, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group Self-Management Sessions

Behavioral

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.

Other names: Self-management intervention

Educational Materials Only

Other

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.

Other names: Content only

Primary outcomes

  1. Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)

    Time frame: 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 outcomes

  1. Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress

    Time frame: 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

  2. Change from Baseline in Score of Neuro-QOL Item Bank v1.0 - Positive Affect and Well-Being

    Time frame: 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

  3. Change from Baseline of score from Neuro-QOL Item Bank v1.0 - Depression

    Time frame: Baseline and immediately post-intervention

    Change from baseline to immediately post-intervention of score from the Neuro-QOL Item Bank v1.0 - Depression survey

  4. Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form

    Time frame: 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

  5. Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function

    Time frame: Baseline

    Score evaluated at baseline from the Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function surveys

  6. Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form

    Time frame: Baseline

    Baseline overall score from the Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form surveys

  7. Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form

    Time frame: 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

  8. Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form

    Time frame: 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

  9. Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a

    Time frame: 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

  10. Survival

    Time frame: Immediate post-intervention, 3 months post-intervention

    Self/contact-reported survival

Study contacts

Contact information is provided by the study sponsor or research team.

Research Services Professional

CONTACT

[email protected]

303-724-1723

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Case Western Reserve University
  • U.S. Army Medical Research and Development Command
  • University Hospitals Cleveland Medical Center

Registry information

Official study title

Pilot Study of the Living Well With Brain Cancer Intervention

Acronym: LWBC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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