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Principal Investigator: Hannah M Fisher
Organization: DUKE UNIVERSITY
Fiscal Year: 2024
Award: $173,997
Funding agency: National Cancer Institute
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; <25% attrition; >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.
Terms: <Address><Adherence><Anxiety><Area><Arousal><Behavior><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Sciences><Behavioral Therapy><Behavioral Treatment><Cancer Patient><Cancer Treatment><Cancers><Caring><Circadian Rhythms><Clinical Trials Design><Conditioning Therapy><Data><Discharge from Health Care Facility><Discharge from Healthcare Facility><Disease><Disease Outcome><Disease remission><Disorder><Distress><Doctor of Philosophy><Dose><Drugs><Ear><Education><Educational aspects><Educational process of instructing><Environment><Fatigue><Fellowship><Future><Goals><Hematologic Cancer><Hematologic Malignancies><Hematologic Neoplasms><Hematological Malignancies><Hematological Neoplasms><Hematological Tumor><Hematopoietic Cancer><High Dose Chemotherapy><High-Risk Cancer><Home><Hospital Admission><Hospitalization><Hospitals><Impairment><Inflammation><Inpatients><Insomnia><Insomnia Disorder><Intervention><Intervention Strategies><Interview><Investigators><Lack of Energy><Life><Malignant Hematologic Neoplasm><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Masks><Medical Device><Medication><Mentorship><Modeling><Morbidity><Morbidity - disease rate><NIH><National Institutes of Health><Nyctohemeral Rhythm><Organism-Level Process><Organismal Process><Out-patients><Outcome><Outpatients><Pain><Painful><Participant><Patient Discharge><Patients><Pattern><Ph.D.><PhD><Pharmaceutical Preparations><Phase><Physiologic Processes><Physiological Processes><Population><Precipitating Factors><Procedures><Protocol><Protocols documentation><Psychiatry><Randomization trial><Randomized><Randomized, Controlled Trials><Remission><Reporting><Research><Research Personnel><Researchers><Schedule><Self Efficacy><Sequential Multiple Assignment Randomized Trial><Severities><Sleep><Sleep disturbances><Sleeplessness><Statistical Methods><Stimulus><Symptom Burden><Symptoms><Teaching><Testing><Training><Treatment Protocols><Treatment Regimen><Treatment Schedule><Twenty-Four Hour Rhythm><United States National Institutes of Health><Work><aberrant sleep><anti-cancer therapy><behavior intervention><behavioral intervention><cancer therapy><cancer-directed therapy><care as usual><circadian process><daily biorhythm><design><designing><develop therapy><disrupted sleep><disturbed sleep><drug/agent><experience><homes><impaired sleep><improved><improvement on sleep><intervention development><interventional strategy><irregular sleep><malignancy><manage symptom><mindfulness><mindfulness intervention><mindfulness meditation><mindfulness-based intervention><mobile app><mobile application><mobile device application><neglect><neoplasm/cancer><pain symptom><painful symptom><patient population><poor sleep><post intervention><preference><primary outcome><professor><psychosocial><quality of sleep><randomisation><randomization><randomized control trial><randomized trial><randomized, clinical trials><randomly assigned><recruit><satisfaction><secondary outcome><skills><sleep disruption><sleep dysregulation><sleep improvement><sleep quality><statistic methods><success><symptom management><symptom self management><telehealth><therapy development><tool><treatment as usual><treatment development><treatment strategy><trial design><understudied cancer><usual care>