Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment

Patients with life-threatening hematologic cancer experience insomnia and fatigue, distress, and pain symptoms

that worsen insomnia during and following hospitalization for high-dose chemotherapy. Despite an urgent need,

there are limited symptom management protocols that comprehensively target the challenging treatment (i.e.,

inpatient, outpatient) and symptom demands faced by hematologic cancer patients. We developed and tested a

6-session, therapist-led, telehealth intervention for hematologic cancer patients following discharge from

inpatient treatment (Nite2Day). Nite2Day teaches mindfulness meditations and behavioral strategies to improve

insomnia and related fatigue, distress, and pain symptoms. Nite2Day demonstrated strong feasibility,

acceptability, and significant improvements to primary (insomnia; d=1.20) and secondary outcomes (fatigue,

distress, mindfulness; ds=.38-.89). Nite2Day does not address the inpatient setting where patients describe

sleep quality as especially poor. This pilot randomized controlled trial will extend Nite2Day to the inpatient setting

(Nite2Day+) and assess its feasibility, acceptability, engagement, and outcome patterns. Hematologic cancer

patients (N=60) reporting insomnia symptoms during hospitalization will be randomized (1:1) to Nite2Day+ or

Usual Care. Nite2Day+ will be delivered via a self-paced mobile app in the hospital and include: 1) mindfulness

meditations promoting acceptance of the challenging inpatient setting; 2) brief videos on sleep education (e.g.,

sleep drive, circadian rhythm) and behavioral strategies to improve inpatient sleep quality (e.g., stimulus control,

daytime activity); and 3) tools to manage inpatient sleep disruptions (e.g., sleep mask, ear plugs). Once

discharged home, patients will transition to the previously tested, 6-session protocol. We hypothesize that: 1)

Nite2Day+ will be feasible (accrual N=60/24 months; 75% adherence to assessments and

intervention), acceptable (M>3/5 satisfaction with procedures; M>3/4 satisfaction with Nite2Day+), and engaging

(Nite2Day+ app log-in, video/skills practice >2x/week); and 2) Nite2Day+ will improve insomnia symptom severity

(primary outcome) and secondary outcomes (fatigue, distress, pain, pre-sleep arousal, mindfulness, symptom

management self-efficacy) from baseline to hospital discharge and after the 6-session protocol, compared to

Usual Care. Dr. Fisher will receive advanced training and expert mentorship in behavioral sleep and cancer

symptom management and behavioral intervention development for inpatient and outpatient settings, and

randomized trial designs and statistical methods for optimizing behavioral treatment regimens to improve the

transition from inpatient to outpatient settings. This training will help Dr. Fisher pursue a future sequential multiple

assignment randomized trial assessing insomnia and symptom management strategies that are responsive to

challenging treatment (i.e., inpatient, outpatient) and heterogeneous symptom demands faced by hematologic

cancer patients. Findings could inform adaptation of other psychosocial interventions for the inpatient setting,

and establish a new model of systematic symptom management for various cancer and hospitalized populations.