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

N/ANot Yet RecruitingNCT07628647

University of Colorado, Denver64 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Brain Cancer

Interventions

Group Self-Management SessionsBEHAVIORAL

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 OnlyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Colorado Anschutz

Aurora, Colorado, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Research Services Professional

CONTACT

303-724-1723 lwbc@cuanschutz.edu

Data from ClinicalTrials.gov

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