C-SMART – Cognitive Strategies, Mindfulness, and Rehabilitation Therapy: Development and Phase I Trial of a Neuropsychological Intervention in Neuro-Oncology
Sarah Braun, Ashlee R Loughan, Autumn Lanoye, Giuliana V Zarrella, Brighton Payne, Amber Fox, Michael W Parsons, William C Broaddus, F Gerard Moeller, Oxana Palesh
Neuro-Oncology Practice October 22, 2026 DOI: 10.1093/nop/npag108 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Single-arm pilot trial (intervention development plus feasibility/acceptability study) Pilot study Qualitative Peer reviewed |
|---|---|
| Sample size | 18 |
| Population | Adult patients with primary brain tumor and mild cognitive decline (n=18), plus their caregivers (n=14); advisory boards of patients/caregivers (n=4) and neuro-oncology professionals (n=5) |
| Interventions | C-SMART (Cognitive Strategies Mindfulness and Rehabilitation Therapy) |
| Topics | Meditation |
| Key findings | The C-SMART intervention met all primary feasibility and acceptability aims, with enrollment, retention, and satisfaction exceeding established benchmarks, and caregivers reported benefit from involvement. Exit interviews supported benefits for self-efficacy and interpersonal functioning, and exploratory outcomes showed signal change, which the authors say supports a Phase II trial. |
Abstract
Abstract:
Background: Adult patients with primary brain tumors experience significant cognitive sequelae yet remain underrepresented in behavioral intervention research. We present the development and preliminary evaluation of C-SMART (Cognitive Strategies, Mindfulness, and Rehabilitation Therapy), an integrated cognitive rehabilitation and mindfulness-based intervention designed for patients with primary brain tumor and mild cognitive decline. Stakeholder input was systematically incorporated prior to launching a single-arm pilot trial assessing feasibility and acceptability.
Methods: Following the NIH ORBIT Model, Phase Ia convened two advisory boards: one comprised of brain tumor patients and caregivers (n=4) and another of neuro-oncology professionals (n=5) to inform C-SMART intervention development. Next, feasibility and acceptability were investigated in a single-arm Phase Ib design (n = 18 patients; n = 14 caregivers), with an exploratory aim of assessing preliminary signal change on neurocognitive performance and patient-reported outcomes.
Results: Phase Ia results supported an individually tailored neuropsychological intervention integrating mindfulness training and caregiver involvement to address patient-centered goals. Phase Ib results met all primary aims of feasibility and acceptability, with rates of enrollment, retention, and satisfaction exceeding established benchmarks. Caregiver involvement was robust, with reported benefit. Qualitative data from exit interviews supported the benefits of C-SMART on self-efficacy and interpersonal functioning with recommendations to increase caregiver involvement. Exploratory outcomes demonstrated signal change, supporting progression to a Phase II trial.
Conclusions: C-SMART is the first consensus-supported, individualized, mindfulness-based, neuropsychological intervention in neuro-oncology. Evidence provides strong support for feasibility and acceptability of the tailored intervention with key recommendations for optimization, including increased structure for caregiver involvement and self-efficacy outcome measurement.
Comparable studies
Other non-randomized and open-label trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Mindfulness-Based Stress Reduction in Relation to Quality of Life, Mood, Symptoms of Stress, and Immune Parameters in Breast and Prostate Cancer Outpatients Early-stage breast and prostate cancer patients | 2003 | Pre-post intervention study | n = 59 |
| Exploring self‐compassion and empathy in the context of mindfulness‐based stress reduction (MBSR) Community sample | 2010 | Pre-post intervention study | |
| Mindfulness-Based Stress Reduction Lowers Psychological Distress In Medical Students Second-year medical students | 2003 | Prospective nonrandomized cohort-controlled study | n = 302 |
| Intensive meditation training, immune cell telomerase activity, and psychological mediators. Retreat participants and matched controls | 2011 | Controlled trial with wait-list control group | n = 60 |
| The Effectiveness of Mindfulness Training for Children with ADHD and Mindful Parenting for their Parents Children aged 8-12 with ADHD and their parents | 2011 | Within-group waitlist controlled trial | n = 22 |