Group Self-Management for Brain Cancer

(LWBC Trial)

Not yet recruiting at 1 trial location
RS
Overseen ByResearch Services Professional
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a group self-management program for individuals diagnosed with brain cancer. The goal is to determine whether this program can be successfully implemented and if it improves mental and behavioral health more effectively than educational materials alone. Participants will either attend virtual group self-management sessions with nurse and peer educators or access educational materials online without group support. It suits those living in the U.S. with a confirmed malignant brain tumor diagnosis who can regularly follow up with their healthcare provider. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in managing brain cancer.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this group self-management program is safe for brain cancer patients?

Research has shown that group self-management programs, like the one in this trial, are generally safe for participants. A similar program, HOBSCOTCH-CA, designed for people with brain cancer, proved to be safe. Another study found that telehealth group sessions were well-received, with 98% of participants choosing to join. These findings suggest that group self-management sessions are safe for most people, with few side effects reported. This evidence supports the safety of joining group sessions aimed at improving mental and behavioral health.12345

Why are researchers excited about this trial?

Researchers are excited about the Group Self-Management approach for brain cancer because it empowers patients to actively participate in their own care through interactive virtual sessions. Unlike standard treatments that primarily focus on medical interventions, this method emphasizes holistic self-management skills taught by nurses and peers. Participants not only gain valuable knowledge but also build a supportive community, which could enhance their overall well-being and quality of life. This approach could complement existing medical treatments by fostering a sense of control and community among patients.

What evidence suggests that this group self-management program is effective for brain cancer?

Research has shown that group activities can significantly enhance mental and behavioral health for brain cancer patients. In this trial, participants in the Group Self-Management Arm will attend eight 90-minute virtual group sessions with nurse and peer educators. One study found that 35% of patients in a group focused on cognitive rehabilitation (helping with thinking and memory) improved, compared to 24% in a group that did not receive this treatment. Another program demonstrated that intensive rehabilitation helped brain tumor patients improve their motor skills, thinking, and daily activities. These findings suggest that organized group sessions can help brain cancer patients manage their condition more effectively. Meanwhile, participants in the Education Only Arm will access educational materials through an online learning management system without group sessions or guidance from nurse or peer educators.678910

Who Is on the Research Team?

BM

Bethany M Kwan, PhD, MSPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with brain cancer or certain types of brain tumors, such as glioblastoma, oligodendroblastoma, papillary ependymoma, or those with brain metastases. Participants should be able to join group sessions and are not excluded by any specific criteria listed.

Inclusion Criteria

Currently living in the United States
Treating prescribing provider who follows regularly with participant
I am 18 years old or older.
See 1 more

Exclusion Criteria

Enrollment in hospice
Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)
Not able to communicate in English at a conversational level
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm attend eight 90-minute virtual group sessions with nurse and peer educators.

8 weeks
8 virtual group sessions

Education Only

Participants access educational materials through an online learning management system without group sessions.

8 weeks

Follow-up

Participants are monitored for changes in mental and behavioral health outcomes post-intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Group Self-Management Sessions

Trial Overview

The study compares a new group self-management program designed to support mental and behavioral health in people with brain cancer against receiving only educational materials. Participants are randomly assigned to either the group sessions or the control group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group Self-Management ArmExperimental Treatment1 Intervention
Group II: Education Only ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

University Hospitals Cleveland Medical Center

Collaborator

Trials
348
Recruited
394,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials
296
Recruited
249,000+

Case Western Reserve University

Collaborator

Trials
314
Recruited
236,000+

Citations

Intensive Rehabilitation Therapy Following Brain Tumor Surgery

To conclude, brain tumor patients who received intensive rehabilitation following surgery achieved improvements in the outcomes of motor, cognition, and ADL ...

Living Well With Brain Cancer: A Group-Based Intervention ...

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 ...

Cognitive Rehabilitation of Brain Tumor Survivors

Between 3-month and 1-year follow-up, improvement was seen in 35% of the intervention group participants compared to 24% of the control group ...

Effects of a Post-Discharge Care Program for Surgery ...

This study developed and applied a post-discharge care program for patients who underwent brain tumor surgery and then examined the effectiveness of the program ...

Advancing Brain Tumor Treatment Through Clinical Research

This session will review the preclinical and laboratory work that is needed to support translating an exciting treatment to the clinic.

Living Well With Brain Cancer: A Group-Based Intervention ...

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 ...

Telehealth group Cognitive–Behavioral Therapy for Insomnia ...

Telehealth group CBT-I was deemed safe. Following the 76% screening rate, 85% of interested individuals met study eligibility and 98% enrolled (N = 44).

Living Well With Brain Cancer: A Group-Based Intervention to ...

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 ...

Co-designing a web-based intervention (RESTORE) to ...

Co-designing a web-based intervention (RESTORE) to support self-management of cancer-related fatigue in people living with a brain tumour.

HOBSCOTCH-CA for Brain Cancer

Research has shown that HOBSCOTCH-CA, a home-based program, is generally safe for participants. The program incorporates problem-solving therapy and ...