This clinical trial evaluates a mindfulness intervention (Nite2Day+) for improving sleep disturbance and other symptoms in patients with hematologic cancer. Patients with hematologic cancer often undergo intensive inpatient treatment, which can lead to a high symptom burden, including sleep disturbance, fatigue, stress, and pain. There are limited insomnia and symptom management protocols targeting the unique and challenging treatment course and symptom demands faced by hematologic cancer patients. Nite2Day+ is a mindfulness-based intervention that integrates mindfulness meditation and sleep strategies with behavioral symptom coping skills to address insomnia and related symptoms such as fatigue, distress, and pain. This intervention combines the use of a mobile application during inpatient treatment with outpatient telehealth sessions after discharge to ensure continuous symptom management across inpatient and outpatient settings. The Nite2Day+ intervention may improve sleep disturbance and symptom outcomes in patients undergoing treatment for hematologic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06532773.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: Hannah Fisher
Phone: 919-613-5550
PRIMARY OBJECTIVES:
I. Test whether Nite2Day+ is feasible, acceptable, and engaging.
II. Examine outcome patterns of Nite2Day+.
III. Conduct exit interviews (n=12) with Nite2Day+ patients to gather qualitative data on preferences, barriers, and facilitators regarding study procedures (i.e., recruitment, inpatient/outpatient delivery, mobile application [app]) and intervention content.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients use the Nite2Day+ app daily during inpatient treatment to access Nite2Day+ intervention material, including mindfulness meditations, sleep education videos, behavioral strategies education videos, interactive and personalized reminders and messages, and symptom assessments. After inpatient treatment, patients attend 6 Nite2Day+ intervention sessions, over 45-60 minutes each, to learn new mindfulness-based sleep strategies, meditations, and behavioral symptom coping skills, and continue to receive access to the Nite2Day+ app with additional features. Patients also receive a study manual, session handouts, and sleep diaries.
ARM II: Patients receive their usual medical care as well as written materials describing free services (e.g., legal and financial assistance, counseling) available through the Duke Cancer Patient Support Program.
After completion of study intervention, patients are followed up at 9 and 13 weeks post-discharge.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorHannah Fisher
