Phase I feedback successfully informed the adaptation of the Nite2Day mindfulness-based insomnia intervention for rural breast cancer patients, with a Phase II single-arm pilot trial currently underway.
A mindfulness-based insomnia intervention was successfully adapted for rural breast cancer patients based on qualitative feedback, with pilot testing underway.
Abstract Introduction 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. Methods 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. Results 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). Conclusion 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. Support (if any) Community Outreach and Engagement Pilot Award, Duke Cancer Institute (P30CA014236).
Fisher et al. (Fri,) conducted a other in Breast cancer and insomnia (n=29). Nite2Day mindfulness-based insomnia and symptom management intervention was evaluated on Feasibility (accrual, attrition, adherence), acceptability, and changes to self-report outcomes. Phase I feedback successfully informed the adaptation of the Nite2Day mindfulness-based insomnia intervention for rural breast cancer patients, with a Phase II single-arm pilot trial currently underway.