[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06532773":3,"trial-entities:NCT06532773":111,"trial-summary:NCT06532773":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":36,"secondary_outcomes":57,"sex":79,"minimum_age":80,"maximum_age":16,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":86,"locations":89,"central_contacts":105,"overall_officials":108,"references":109,"see_also_links":110},"NCT06532773","Pro00115799","Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment","RECRUITING","2029-06-30","2026-07","2026-07-08","2026-01-14","Duke University","OTHER",true,"People with hematologic cancer often have sleep disturbance and symptoms of fatigue, stress, and pain. This study is being done to test a mindfulness intervention for sleep disturbance and symptom management in patients with hematologic cancer during and after inpatient treatment (Nite2Day+). Participants will complete a baseline survey online, using a mobile application, or paper\u002Fpencil. Once the baseline survey is complete, participants will be randomized (like a flip of a coin) to receive Nite2Day+ or Standard Care. Nite2Day+ will include activities during and after inpatient treatment. During inpatient treatment, participants will use a mobile app to access: 1) mindfulness meditations, 2) brief sleep education videos, and 3) brief videos teaching strategies to improve sleep quality in the hospital. After inpatient treatment, participants will complete 6, videoconference sessions (45-60 minutes) with a trained therapist to learn mindfulness and behavioral coping strategies to self-manage nighttime sleep disturbance and daytime symptoms of fatigue, stress, and pain. Three follow-up surveys will occur at hospital discharge, and approximately 8, and 12 weeks after hospital discharge. Participants randomized to Nite2Day+ will be given the option to complete an exit interview to provide feedback on the Nite2Day+ program. Participants randomized to Standard Care will only complete the four surveys. All participants will continue to receive their usual medical care. The total study duration is about 16 weeks.",null,[18],"Hematologic Malignancy",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},60,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Nite2Day+","Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.",[30],[34,35],"Mindfulness Based Therapy for Insomnia","Cognitive Behavioral Symptom Coping Skills",[37,41,45,48,51,54],{"measure":38,"description":39,"timeFrame":40},"Feasibility as measured by study accrual","Treatment feasibility will be shown by meeting targeted study accrual (N = 60 in 24 months).","24 months of study recruitment",{"measure":42,"description":43,"timeFrame":44},"Feasibility as measured by study attrition","Treatment feasibility will be shown by no more than 25% study attrition.","Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)",{"measure":46,"description":47,"timeFrame":44},"Feasibility as measured by adherence","Adherence will be indicated by at least 75% of study sessions and assessments completed.",{"measure":49,"description":50,"timeFrame":44},"Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)","Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ. Items are rated on a 4-point scale from 1 (low) to 4 (high) and averaged to obtain an acceptability score ranging from 1 to 4, with higher scores indicating higher acceptability.",{"measure":52,"description":53,"timeFrame":44},"Engagement as measured by Nite2Day+ app and skills use","Engagement will be indicated by Nite2Day+ app log-in and skills practice at least 2 times per week.",{"measure":55,"description":56,"timeFrame":44},"Change in insomnia symptoms","Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI). Items are summed to yield a total score ranging from 0 to 28, with higher scores indicating worse insomnia symptoms.",[58,61,64,67,70,73,76],{"measure":59,"description":60,"timeFrame":44},"Change in fatigue","Fatigue symptoms will be assessed using the 8-item PROMIS Fatigue Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicated higher fatigue.",{"measure":62,"description":63,"timeFrame":44},"Change in depressive symptoms","Depressive symptoms will be assessed using the 8-item PROMIS Depression Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate higher worse depressive symptoms.",{"measure":65,"description":66,"timeFrame":44},"Change in anxiety symptoms","Anxiety symptoms will be assessed using the 8-item PROMIS Anxiety Short Form. A raw score is calculated by summing all 8 items, yielding a total raw score that ranges from 8 to 40. The total raw score is then translated to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate worse anxiety symptoms.",{"measure":68,"description":69,"timeFrame":44},"Change in pain severity","Pain severity will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 4 items assessing pain severity, including worst, least, average, and current pain in the past week. Responses range from 0 (no pain) to 10 (pain as bad as you can imagine); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain severity.",{"measure":71,"description":72,"timeFrame":44},"Change in pain interference","Pain interference will be assessed using the 11-item Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF consists of 7 items assessing the degree to which pain has interfered with patients' daily activities in the past week. Responses range from 0 (does not interfere) to 10 (completely interferes); items are averaged for a composite score that ranges from 0 to 10 with higher scores indicating high pain interference.",{"measure":74,"description":75,"timeFrame":44},"Change in mindfulness","Mindfulness will be assessed using the 10-item Cognitive and Affective Mindfulness Scale - Revised. Participants will be asked to rate their level of mindfulness across two domains (cognitive and affective) using a 4-point response scale ranging from 1 (rarely\u002Fnot at all) to 4 (almost always). Items are summed to yield a total score, with higher scores reflecting greater mindfulness.",{"measure":77,"description":78,"timeFrame":44},"Change in self-efficacy for symptom management","Self-efficacy for symptom management will be assessed using the 8-item PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms Scale. Participants will rate their confidence in managing their symptoms using a 5-point response scale from 1 (I am not at all confident) to 5 (I am very confident). Items are summed and converted to a T-score, which is a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores indicate better self-efficacy for symptom management.","ALL","18 Years",false,{"inclusion":83,"exclusion":84,"raw_text":85},[],[],"Inclusion Criteria:\n\n1. Male and female patients, \\>18 years old\n2. Initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin's lymphoma, multiple myeloma, or myelodysplastic syndrome\n3. at least 7 days of hospitalization for treatment (e.g., chemotherapy, CAR-T immunotherapy)\n4. 8 or greater on the Insomnia Severity Index with timeframe adjusted to be \"past 7 days\"\n5. Ability to speak and read English, and intact hearing and vision\n\nExclusion Criteria:\n\n1. Reported or suspected cognitive impairment, confirmed via Folstein Mini-Mental Status Exam \\\u003C25\n2. Serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, oncologist, or other provider\n3. Expected survival of \\\u003C6 months",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"status":7,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":102},"2400 Pratt Street","Durham","North Carolina","27705","United States",[97],{"name":98,"role":99,"phone":100,"email":101},"Hannah M Fisher","CONTACT","919-416-3471","hannah.fisher@duke.edu",{"lat":103,"lon":104},35.99403,-78.89862,[106],{"name":107,"role":99,"phone":100,"email":101},"Hannah M Fisher, PhD",[],[],[],{"nct_id":4,"conditions":112,"biomarkers":119},[113,114,115,116,117,118],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Hematologic Neoplasm","Multiple Myeloma","Myelodysplastic Syndrome","Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":14,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an interventional study where about 60 participants will be randomly assigned (like a coin flip) to either receive the Nite2Day+ program or standard care.","completed","Mindfulness for Sleep and Symptoms in Hematologic Cancer","This study is testing a program called Nite2Day+ to help people with blood cancers (hematologic malignancy) manage sleep problems, fatigue, stress, and pain. Nite2Day+ uses mindfulness-based sleep strategies and coping skills. You could join if you are an adult (18 or older) with certain blood cancers like acute myeloid leukemia or multiple myeloma, and are hospitalized for at least 7 days for treatment. The study aims to see if Nite2Day+ is practical to offer, by looking at how many people join, how many stay in the study, and how well they follow the program. After completing a survey, you would be randomly assigned to receive Nite2Day+ or standard care. The study is currently recruiting about 60 participants.","Participants will be followed for about 17 weeks after starting the study, with assessments at baseline, discharge, 13 weeks, and 1-month post-intervention.",117,"You will complete a baseline survey and then participate in Nite2Day+ activities during and after inpatient treatment. Your participation will be tracked at baseline, discharge, 13 weeks, and 17 weeks.","Not stated in the trial record.",[30],"v2"]