Recruiting

Self-Management Program

Sponsor:

University of Colorado, Denver

Code:

NCT07628647

Conditions

Brain Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group Self-Management Sessions

Educational Materials Only

Study Details

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

Study ID

NCT07628647

Start date

Jun 10, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group Self-Management Arm

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.

active comparator: Education Only Arm

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.

Interventions

Group 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.

Educational Materials Only

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Research Services Professional

303-724-1723lwbc@cuanschutz.edu

Locations

University of Colorado Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Research Services Professional

LWBC@cuanschutz.edu

Principal Investigator:

Bethany M Kwan, PhD, MSPH

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Molly McVoy, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.