The National Cancer Institute clinical trials planning meeting to address gaps in observational and intervention trials for cancer-related cognitive impairment
Cancer-related cognitive impairment is a broad term encompassing subtle cognitive problems to more severe impairment. The severity of this impairment is influenced by host, disease, and treatment factors, and the impairment affects patients before, during, and following cancer treatment. The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee (SxQoL SC) convened a clinical trial planning meeting to review the state of the science on cancer-related cognitive impairment and develop phase II/III intervention trials aimed at improving cognitive function in cancer survivors with non-central nervous system disease and longitudinal studies to understand the trajectory of cognitive impairment and contributing factors. Participants included experts in the field of cancer-related cognitive impairment, members of the SxQoL SC, patient advocates, representatives from all 7 NCI Community Oncology Research Program research bases, and the NCI. Presentations focused on the following topics: measurement, lessons learned from pediatric and geriatric oncology, biomarker and mechanism endpoints, longitudinal study designs, and pharmacological and behavioral intervention trials. Panel discussions provided guidance on priority cognitive assessments, considerations for remote assessments, inclusion of relevant biomarkers, and strategies for ensuring broad inclusion criteria. Three clinical trial planning meeting working groups (longitudinal studies as well as pharmacological and behavioral intervention trials) convened for 1 year to discuss and report on top priorities and to design studies. The meeting experts concluded that sufficient data exist to advance phase II/III trials using selected pharmacological and behavioral interventions for the treatment of cancer-related cognitive impairment in the non-central nervous system setting, with recommendations included herein.
Authors
- Jeffrey Scott Wefel (ORCID: https://orcid.org/0000-0003-3584-023X)
- Brian D. Gonzalez (ORCID: https://orcid.org/0000-0001-5108-5735)
- Cobi J. Heijnen (ORCID: https://orcid.org/0000-0002-1928-3050)
- Glenn Jay Lesser (ORCID: https://orcid.org/0009-0003-5471-8907)
- Vinai Gondi
- Yvette P. Conley (ORCID: https://orcid.org/0000-0002-1784-6067)
- Brenna C. McDonald (ORCID: https://orcid.org/0000-0001-6895-4490)
- Saurabh Dahiya (ORCID: https://orcid.org/0000-0001-8291-1796)
- Michelle Monje (ORCID: https://orcid.org/0000-0002-3547-237X)
- Robert J. Ferguson (ORCID: https://orcid.org/0000-0001-9711-022X)
- Andrew J. Saykin (ORCID: https://orcid.org/0000-0002-1376-8532)
- Thuy T. Koll
- Debra L. Barton (ORCID: https://orcid.org/0000-0001-6624-3476)
- David A. Morilak (ORCID: https://orcid.org/0000-0001-6689-6258)
- Worta McCaskill‐Stevens (ORCID: https://orcid.org/0000-0002-0487-7526)
- Judith O. Hopkins (ORCID: https://orcid.org/0000-0002-9829-1242)
- Karen Michelle Mustian (ORCID: https://orcid.org/0000-0001-6525-7518)
- Diane St. Germain (ORCID: https://orcid.org/0000-0003-0399-5579)
- Peter D. Cole (ORCID: https://orcid.org/0000-0002-3525-8015)
- Christina K. Cramer (ORCID: https://orcid.org/0000-0001-7618-3921)
- Stephen R. Rapp (ORCID: https://orcid.org/0000-0002-9766-3104)
- Leanne Embry
- Alicia Katherine Morgans (ORCID: https://orcid.org/0000-0002-6563-4587)
- Allison Magnuson (ORCID: https://orcid.org/0000-0002-0968-8265)
- Donald Mabbott (ORCID: https://orcid.org/0000-0001-6161-5066)
- Kristina K. Hardy (ORCID: https://orcid.org/0000-0002-5479-5043)
- Lynne I. Wagner (ORCID: https://orcid.org/0000-0001-9685-4796)
- Michelle C. Janelsins (ORCID: https://orcid.org/0000-0003-2258-7247)
- Sheri J. Hartman (ORCID: https://orcid.org/0000-0002-3719-0624)
- James C. Root (ORCID: https://orcid.org/0000-0001-7332-6165)
- Susan G. Dorsey (ORCID: https://orcid.org/0000-0001-7648-1312)
- Kathleen Van Dyk (ORCID: https://orcid.org/0000-0003-1500-930X)
- Patricia A. Ganz (ORCID: https://orcid.org/0000-0002-1841-4143)
- Alexis Bakos
- Catherine Bender
Institutions
- Rutgers, The State University of New Jersey (US)
- University of North Carolina at Chapel Hill (US)
- University of Maryland, Baltimore (US)
- Atrium Health Wake Forest Baptist (US)
- Memorial Sloan Kettering Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- University of California, Los Angeles (US)
- The University of Texas at San Antonio Health Science Center (US)
- University of Pittsburgh (US)
- Hospital for Sick Children (CA)
- Knoxville College (US)
- University of Rochester Medical Center (US)
- Moffitt Cancer Center (US)
- University of California San Diego (US)
- National Institute of Neurological Disorders and Stroke (US)
- Southeast Clinical Oncology Research Consortium (US)
- Dana-Farber Cancer Institute (US)
- Human Longevity (United States) (US)
- National Cancer Institute (US)
- Northwestern Medicine (US)
- Wake Forest Baptist Comprehensive Cancer Center
- UCLA Jonsson Comprehensive Cancer Center
- Indiana University School of Medicine
- Indiana University – Purdue University Indianapolis (US)
- University of Nebraska Medical Center (US)
- Rice University (US)
- University of Tennessee at Knoxville (US)
- Stanford University (US)
Publication Details
- Journal
- JNCI Journal of the National Cancer Institute
- Published
- 2024-09-09
- DOI
- https://doi.org/10.1093/jnci/djae209
- Citations
- 13
- Primary Topic
- Cancer-related cognitive impairment studies
- Type
- article
- Field-Weighted Citation Impact
- 5.45
Funders
- U.S. Department of Health and Human Services
- National Institutes of Health
- National Cancer Institute