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

University of Colorado Denver (CU Denver)

Status: Not yet enrolling

Conditions: Brain Cancer

Treatments: Other: Educational Materials Only; Behavioral: Group Self-Management Sessions

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07628647

25-2124

HT9425-24-1-0883 (Other Grant/Funding Number)

Details and patient eligibility

About

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?

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Group Self-Management Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Group Self-Management Sessions

Education Only Arm

Active Comparator group

Description:

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.

Treatment:

Other: Educational Materials Only