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

NCT07628647 | Not Yet Recruiting

• 2 other identifiers: 25-2124HT9425-24-1-0883
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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?

Conditions

Brain Cancer

Keywords

Brain cancer; Glioblastoma; Astrocytoma; Ependymoma; Oligodendroglioma; Brain tumor; Mental health; Glioma; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, immediately post-intervention, and 3 months post-intervention

Secondary Outcomes (10)

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

  Baseline and immediately post-intervention

• 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 of score from Neuro-QOL Item Bank v1.0 - Depression

  Baseline and immediately post-intervention

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

  Baseline and immediately post-intervention

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

  Baseline

Study Arms (2)

Group Self-Management Arm

EXPERIMENTAL

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

Education Only Arm

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Self-management intervention

Group Self-Management Arm

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.

Also known as: Content only

Education Only Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: collaborator
• U.S. Army Medical Research and Development Command: collaborator
• Case Western Reserve University: collaborator
• University of Colorado, Denver: lead

Study Sites (2)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

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MeSH Terms

Conditions

Brain Neoplasms; Glioblastoma; Astrocytoma; Ependymoma; Oligodendroglioma; Psychological Well-Being; Glioma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Personal Satisfaction; Behavior

Study Officials

• Bethany M Kwan, PhD, MSPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Services Professional

CONTACT

303-724-1723; lwbc@cuanschutz.edu

Study Design

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

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)