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.
- Study design
- 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.
- What's involved
- 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.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for about 17 weeks after starting the study, with assessments at baseline, discharge, 13 weeks, and 1-month post-intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Feasibility as measured by study accrual24 months of study recruitment
Treatment feasibility will be shown by meeting targeted study accrual (N = 60 in 24 months).
- Feasibility as measured by study attritionBaseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Treatment feasibility will be shown by no more than 25% study attrition.
- Feasibility as measured by adherenceBaseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Adherence will be indicated by at least 75% of study sessions and assessments completed.
- Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
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.
- Engagement as measured by Nite2Day+ app and skills useBaseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
Engagement will be indicated by Nite2Day+ app log-in and skills practice at least 2 times per week.
- Change in insomnia symptomsBaseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks)
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.