Clinical trial of feasibility for mindfulness intervention for patients with newly diagnosed high grade glioma.
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2025-11
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Abstract
Purpose
With a bleak prognosis for malignant glioma, maintaining quality of life (QoL) and decreasing distress are essential in patient clinical care. Mindfulness meditation is a mind-body therapy that is being investigated as a non-pharmacological strategy to alleviate cancer symptoms and improve QoL. Given the potential of this intervention, we hypothesized that mindfulness meditation is feasible and may benefit patients with brain tumors on active therapy by decreasing stress and anxiety.Methods
Patients with newly diagnosed WHO grade 3-4 malignant glioma were enrolled to evaluate the feasibility of a mindfulness intervention that coincided with standard of care chemoradiation. The intervention consisted of six weekly one-hour telephone-based mindfulness sessions followed by one in-person mindfulness session. QoL was measured by standardized patient-reported outcome questionnaires pre- and post-intervention. Feasibility was assessed within three domains: acceptability, demand, and implementation.Results
Over a four-month period, 27 patients were offered the opportunity to participate in this study, of which 15 participated. Median age at enrollment was 60 years (range 28-76 years), with enrollees being predominantly female (73.3%) and white (100%). The average percentage of sessions that the patient attended was 82.86% (SD = 28.16). Of the 10 patients who completed the exit interview, 70% indicated they would continue practicing mindfulness. For patients that attend all seven sessions, >50% of patients found the sessions beneficial.Conclusions
Mindfulness intervention during active treatment for patients with high grade glioma is feasible. Given these results, a larger study has the potential to benefit patients with high grade glioma on active treatment.Type
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Publication Info
Ramamurthy, Kavya, Dina M Randazzo, Nicole Cort, James E Herndon, Evan Buckley, Mary Lou Affronti, Jung-Young Kim, Mallika P Patel, et al. (2025). Clinical trial of feasibility for mindfulness intervention for patients with newly diagnosed high grade glioma. Journal of neuro-oncology, 176(1). p. 71. 10.1007/s11060-025-05325-1 Retrieved from https://hdl.handle.net/10161/34355.
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Scholars@Duke
Mary Louise Affronti
Dr. Mary Lou Affronti DNP, RN, MHSc, ANP, FAAN is a Clinical Professor, Assistant Dean of the Doctor of Nursing Practice Program and Director of the Oncology Specialty who joined the Duke University School of Nursing faculty in February 2014. She is the Adult Gerontology Nurse Practitioner and Oncology Specialty Lead Faculty. She earned both her DNP and her MSN at DUSON and additionally earned a Master of Health Science degree in Clinical Research from the Duke University School of Medicine. She held a Clinical Associate faculty appointment in the Duke University Medical Center Department of Surgery /Neurosurgery. She is also Primary Investigator and Adult Nurse Practitioner at the Preston Robert Tisch Brain Tumor Center in the Duke Cancer Institute.
Dr. Affronti has been a part of Duke’s oncology clinical and research community for over four decades and has been associated with DUSON since 1989 in a variety of roles, including clinical associate, guest lecturer, preceptor, and clinical instructor. She was instrumental in developing the oncology curriculum for DUSON nurse practitioner students. In 2005, she was honored by the Friends of Nursing at Duke with the Evelyn Morgan Award for Excellence in Oncology Nursing. Dr. Affronti’s DNP Project on adherence to antiemetic guidelines in patients with malignant glioma, received the Outstanding Capstone Doctoral Project Award in 2013, was published in Supportive Care in Cancer, and was cited in 2016 New England Journal of Medicine Antiemetic Review Article. Dr. Affronti was the Recipient of the Southern Nursing Research Society Clinical Research Award in 2018. In recognition of her many scholarly, teaching, service, and practice contributions, she was inducted as a Fellow in the American Academy of Nursing (FAAN) and was a Great 100 Nurses in North Carolina award recipient in 2020.
Dr. Affronti has been developing and leading therapeutic and supportive care research while seeing patients in the consult setting as a nurse practitioner and is continuing both her clinical and research activities at the Brain Tumor Center. She has a strong interest in the development and testing of therapies and supportive care for primary brain tumors as a co-principal or principal investigator on many Phase II clinical trials at the Duke Brain Tumor Center. She was chairman of the Multinational Association of Supportive Care in Cancer (MASCC) guideline committee on Patient Antiemetic Guidelines and a member on the 2023 global antiemetic guideline committee. She is co-chair of the MASCC Antiemetic Study Group and a Society for Neuro-Oncology Board Member representative for the neuro-oncology advanced practice providers and allied health.
Margaret Johnson
I am a neuro-oncologist, neurologist, and palliative care physician at the Preston Robert Tisch Brain Tumor Center. I also provide neuro-oncology expertise for the National Tele-Oncology Program and National Precision Oncology Program at the Veteran's Health Administration. My clinical and research interests encompass supportive care and palliative care with a special interest in older adults with brain tumors. The incidence of malignant brain tumors like glioblastoma and non-malignant tumors like meningioma affect aging populations and it is crucial to be able to provide better care for these patients.
Mustafa Khasraw
I am a physician-scientist with a background in medical oncology and neuro-oncology, with affiliations to multiple departments, research, and training programs at Duke.
I lead a Tumor Immunology Lab where we use various wet and dry lab techniques to understand the interactions between tumors and the immune system. Our goal is to identify vulnerabilities that can be targeted for novel therapies.
I serve as the Deputy Director of the Center for Cancer Immunotherapy at the Duke Cancer Institute where we are tasked to facilitate clinical research and translate promising discoveries made by scientists across various departments and cancer types at Duke, particularly in the field of immune and T cell-based therapies.
My team and our laboratory operate in an environment that enables the transition from bench-side basic scientific discoveries to clinical trials, and back to the bench ensuring the evaluation of new treatments for cancer patients.
Annick Desjardins
David Michael Ashley
My career in cancer research dates more than two decades. I am credentialed in both pediatric and adult neuro-oncology practice and this has been the focus of my efforts in translational research and leadership. As evident from my publication and grant support record, my primary academic focus has been on neurologic tumors, the development of innovative therapies and approaches to care. These efforts have included basic and translational laboratory research. My experience includes moving laboratory findings in brain tumor immunology and epigenetics into early phase clinical trials. I have expertise in immuno-oncology, having developed and clinically tested dendritic cell vaccines and other immuno-therapeutics. My achievements in research have led to change in practice in the care of children and adults with brain tumors, including the introduction of new standards of practice for the delivery of systemic therapy. I am highly regarded for this work, as evidenced by numerous invitations to plenary sessions and symposia of international standing. I have been the principal investigator of a number of important national and international studies, both clinical and pre-clinical. I am recognized as a senior figure and opinion leader in neuro-oncology nationally and internationally. I have held several significant leadership roles, including Director of two major cancer centers, I served as the Chair of Medicine at Deakin University, the Program Director of Cancer Services at University Hospital Barwon Health, and Executive Director of the Western Alliance Academic Health Science Centre (Australia). I began my current position as Director of The Preston Robert Tisch Brain Tumor Center, Head, Preuss Laboratory, in March 2018. In this role, I am responsible for the clinical care, research, and educational program related to Brain Tumor Center. I am also a senior investigational neuro-oncologist within the adult brain tumor program at Duke.
Henry Seth Friedman
Overview: Our laboratory is pursuing a comprehensive analysis of the biology and therapy of adult and childhood central nervous system malignancies, particularly high-grade medulloblastoma, glioma, and ependymoma.
Laboratory Studies: Active programs, using human adult and pediatric CNS tumor continuous cell lines, transplantable xenografts growing subcutaneously and intracranially in athymic nude mice and rats, and as well as in the subarachnoid space of the athymic nude rats, and patients tumor specimens, are defining:
1) the chemotherapeutic profile of medulloblastoma, adult and childhood glioma and ependymoma
2) mechanisms of resistance to classical bifunctional alkylators, nitrosoureas and methylators operational in malignant glioma and medulloblastoma, particularly DNA adduct and crosslink repair, O6-alkylguanine-DNA alkyltransferase elevation and DNA mismatch repair deficiency.
3) modulations designed to over come or circumvent specific mechanisms of resistance
4) the activity of signal pathway inhibitors of EGFR, m-tor and other targets
5) the therapeutic advantages of intrathecal and intratumoral drug delivery in the treatment of neoplastic meningitis and intracranial malignancies, respectively.
The results of the therapeutic studies to date have demonstrated the marked activity of alkylating agents, particularly melphalan and cyclophosphamide and the role of glutathione, AGT glutathione-S-transferase, abnormal drug transport and alterations in formation and repair of DNA-DNA crosslinks in modulating cytotoxicity of these agents. Modulations shown to be effective in enhancing alkylator activity/reversing alkylator resistance include BSO-mediated glutathione depletion, inhibition of DNA-DNA crosslink repair and inhibition of 06-alkylguanine-DNA alkyltransferase by 06-benzylguanine. Recent studies have demonstrated profound activity of temozolomide, CPT-11 topotecan, irofulven, and karenitecin as well as the combination of CPT-11 or topotecan plus BCNU or temozolomide. Successful treatment of neoplastic meningitis in nude rats with intrathecal 4-hydroperoxycyclophosphamide, melphalan, temozolomide and busulfan, and intracranial glioma in nude rats with intratumoral temozolomide has also been demonstrated. More recent studies have revealed cyclophosphamide resistance secondary to DNA interstrand crosslink repair. Additional studies have shown that cyclophosphamide crosslinks are formed at the 1,3 N7 position, serving as the basis for construction of a defined crosslink in a plasmid vector to assay for crosslink repair and allowing demonstration of the lack of a role of nucleotide excision repair. Mismatch repair deficiency has been shown as a mechanism mediating acquired methylator (procarbazine and temozolomide) resistance in an adult glioblastoma xenograft.
Clinical Studies: Clinical investigations are designed to translate laboratory programs into successful treatment for adults and children with malignant brain tumors, particularly medulloblastoma. Clinical trials for adults include phase II trials of temozolomide, ZD1839 (Iressa), karenitecin, and temozolomide plus O6-BG as well as phase I trials of topotecan plus BCNU, CPT-11 plus temozolomide, and PTK787 ± temozolomide or CCNU. Studies are in progress in children evaluating the activity CPT-11 plus temozolomide, intrathecal busulfan and cyclophosphamide/melphalan or cyclophosphamide/busulfan plus autologous bone marrow support . Extension of these studies to a larger cohort of patients is being performed nationally under the auspices of the Pediatric Brain Tumor Consortium (Henry S. Friedman -- Head of New Agents Committee).
Future studies will address the role of agents designed to decrease repair of interstrand crosslinks when given in combination with alkylating agents, as well as newer signal pathway inhibitors such as RAD001, PKI166, and DB-67.
Katherine Barnett Peters
Katy Peters, MD, PhD, FAAN is a professor of neurology and neurosurgery at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke. Her academic medical career started at Stanford University School of Medicine, receiving an MD and Ph.D. in Cancer Biology. After completing a neurology residency at Johns Hopkins University and a fellowship in cognitive neurosciences, Katy joined the PRTBTC as a neuro-oncology fellow. In 2009, she became a faculty member at PRTBTC. With a fantastic team of nursing and advanced practice providers, she actively sees and cares for patients with primary brain tumors. Her research interests include supportive care for brain cancer patients, cognitive dysfunction in cancer patients, and physical function and activity of brain cancer patients. While she runs clinical trials to treat primary brain tumors, her key interest is on clinical trials that focus on improving brain tumor patients' quality of life and cognition. In 2019, the PRTBTC designated her as the Director of Supportive Care, thus furthering the PRTBTC and her committee to better the quality of life for brain tumor patients. She is active in teaching medical school students, residents, fellows, and advanced practice providers and is the Program Director of the PRTBRC neuro-oncology fellowship. She is board certified by the American Board of Psychiatry and Neurology and the United Council of Neurologic Subspecialties for neuro-oncology.
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