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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07628647
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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?

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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.

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

Locations (2)

FacilityCityStateZIP
University of Colorado AnschutzAuroraColorado80045
University Hospitals Cleveland Medical CenterClevelandOhio44106

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