0449 Adaptation and Pilot Testing of a Mindfulness-Based Insomnia and Symptom Management Intervention for Women with Breast Cancer in Rural Areas
Hannah M. Fisher, Natalie Chou, Emily Patterson, Laura Fisher, M. Falkovic, C. Makarushka, Heather E. Parnell, Shauna Malone, Linda M Sutton, Lynda Owen, Kara Kenan, Tamara J. Somers
SLEEPJ May 1, 2026 DOI: 10.1093/sleep/zsag091.0448 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Mixed-methods study (qualitative interviews plus single-arm pilot trial) Pilot study Peer reviewed |
|---|---|
| Sample size | 29 |
| Population | Breast cancer patients and oncology clinicians in rural, medically underserved areas (Phase I: 8 patients, 6 clinicians; Phase II: 15 patients planned) |
| Duration | 6-session intervention; Phase II follow-up to 1-month post-intervention |
| Measures | Insomnia Severity Index, PROMIS-Fatigue, PROMIS-Anxiety, PROMIS-Depression, Brief Pain Inventory, Cognitive and Affective Mindfulness Scale, PROMIS-Self-Efficacy for Managing Symptoms |
| Topics | Meditation |
| Key findings | Phase I interviews indicated that insomnia is common and worsens after breast cancer diagnosis, with a mean Insomnia Severity Index total of 13 (SD=6). Participants were enthusiastic about the remote, individual, six-session Nite2Day protocol, and feedback informed adaptations such as telephone and evening sessions and revised mindfulness definitions. The Phase II single-arm pilot trial is underway with 7 of 15 participants enrolled. |
Abstract
Insomnia is a prevalent symptom that exacerbates other cancer symptoms (e.g., fatigue, distress, pain), that in turn worsen sleep. Behavioral interventions are recommended for insomnia but are often not adapted or made available for cancer patients in rural, medically underserved areas. Nite2Day is a mindfulness-based, behavioral insomnia and symptom management intervention previously pilot-tested in hematologic cancer. We are conducting a mixed-methods study to adapt and pilot test Nite2Day in breast cancer patients in rural, medically underserved areas. Phase I involved interviews with breast cancer patients (N=8) and oncology clinicians (N=6). Patients self-reported insomnia (Insomnia Severity Index), fatigue (PROMIS-Fatigue), distress (PROMIS-Anxiety; Depression), pain (Brief Pain Inventory), mindfulness (Cognitive and Affective Mindfulness Scale), and self-efficacy (PROMIS-Self-Efficacy for Managing Symptoms). Interviews were audio-recorded and transcriptions were analyzed using rapid qualitative analysis. Phase II involves a single-arm pilot trial (N=15) to evaluate feasibility (accrual, attrition, adherence), acceptability (intervention satisfaction), and changes to self-report outcomes from baseline to post- and 1-month post-intervention. Phase I patients (Mage=60, 63% Black, 56% Stage I) and clinicians (e.g., oncologist; Mage=48, 83% Female, 50% White) reported that insomnia symptoms are common and worsen post-diagnosis (M ISI Total: 13 [SD=6]). Reasons for insomnia included physical (e.g., pain) and psychological (e.g., stress) symptoms, and lifestyle behaviors (e.g., caffeine, napping). Participants were enthusiastic about the protocol, especially its focus on mindfulness and behavioral skills to address symptoms, as well as its remote, individual, and brief (6-session) format. Some concerns were cited regarding videoconferencing technology, session scheduling, and mindfulness definitions. Telephone and evening sessions were made available, and definitions of mindfulness principles (e.g., beginner’s mind) were revised to incorporate images and examples relevant to breast cancer. Phase II is underway (N=7/15). Phase I feedback informed adaptation of the Nite2Day protocol for breast cancer patients in rural, medically underserved areas. If Phase II pilot results are positive, next steps include efficacy testing. This research has the potential to expand access to a mindfulness-based, behavioral insomnia and symptom management intervention to a population with limited access to critical symptom management. Community Outreach and Engagement Pilot Award, Duke Cancer Institute (P30CA014236).
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 |