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

Official title

Pilot Study of the Living Well With Brain Cancer Intervention

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?

Interventions

• Behavioral 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.
• Other 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 measures

• 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]

Secondary outcome measures (10)

• Change from Baseline in Score of NIH Toolbox Item Bank v3.0 - Perceived Stress [Time frame: Baseline and immediately post-intervention]
• Change from Baseline 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 [Time frame: Baseline and immediately post-intervention]
• Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Fatigue - Short Form [Time frame: Baseline and immediately post-intervention]
• Overall Score from Neuro-QOL Item Bank v1.0 - Upper Extremity Function and Lower Extremity Function [Time frame: Baseline]
• Overall score from Neuro-QOL Item Bank v1.0 - Cognitive Function - Short Form and Emotional and Behavioral Dyscontrol - Short Form [Time frame: Baseline]
• Change from Baseline in Score from Neuro-QOL Item Bank v1.1 - Satisfaction with Social Roles and Activities - Short Form [Time frame: Baseline and immediately post-intervention]
• Change from Baseline in Score from Neuro-QOL Item Bank v1.0 - Sleep Disturbance - Short Form [Time frame: Baseline and immediately post-intervention]
• Change from Baseline of Score from PROMIS Item Bank v1.0 - Self Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 8a [Time frame: Baseline and immediately post-intervention]
• Survival [Time frame: Immediate post-intervention, 3 months post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• University of Colorado Anschutz — Aurora
• University Hospitals Cleveland Medical Center — Cleveland

Publications

• Krippendorff K. Content analysis: An introduction to its methodology. Sage publications; 2013.
• Stemler S. An overview of content analysis. Practical Assessment. Research & Evaluation. 2001;7(17): 137-146.
• Gruber-Baldini AL, Velozo C, Romero S, Shulman LM. Validation of the PROMIS(R) measures of self-efficacy for managing chronic conditions. Qual Life Res. 2017 Jul;26(7):1915-1924. doi: 10.1007/s11136-017-1527-3. Epub 2017 Feb 26. PMID 28239781
• Gabel N, Altshuler DB, Brezzell A, Briceno EM, Boileau NR, Miklja Z, Kluin K, Ferguson T, McMurray K, Wang L, Smith SR, Carlozzi NE, Hervey-Jumper SL. Health Related Quality of Life in Adult Low and High-Grade Glioma Patients Using the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) and Neuro-QOL Assessments. Front Neurol. 2019 Mar 15;10:212. doi: 10 PMID 30930834
• Gershon RC, Lai JS, Bode R, Choi S, Moy C, Bleck T, Miller D, Peterman A, Cella D. Neuro-QOL: quality of life item banks for adults with neurological disorders: item development and calibrations based upon clinical and general population testing. Qual Life Res. 2012 Apr;21(3):475-86. doi: 10.1007/s11136-011-9958-8. Epub 2011 Aug 27. PMID 21874314
• Bunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1. PMID 28472964
• Blixen C, Perzynski A, Kanuch S, Dawson N, Kaiser D, Lawless ME, Seeholzer E, Sajatovic M. Training peer educators to promote self-management skills in people with serious mental illness (SMI) and diabetes (DM) in a primary health care setting. Prim Health Care Res Dev. 2015 Apr;16(2):127-37. doi: 10.1017/S1463423614000176. Epub 2014 Apr 7. PMID 24703014
• Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15. PMID 1100130

Identifiers

NCT: NCT07628647 · 25-2124 · HT9425-24-1-0883

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗