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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA283026 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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/pencil. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nite2Day+ | Experimental | During inpatient treatment, Nite2Day+ will be delivered via a self-paced mobile app. Participants will use the app to access: 1) mindfulness meditations (e.g., Body Scan, 3-Minute Mini-Meditation) from Mindfulness Based Therapy for Insomnia (MBTI); 2) brief, 3-5 minute sleep education videos (i.e., 3-P Model of Insomnia, sleep hygiene, sleep drive, circadian rhythm) specifically tailored to the inpatient setting; and 3) brief, 3-5 minute videos teaching behavioral strategies (e.g., stimulus control, daytime activity, light exposure, communication with medical team) to improve sleep quality in the hospital. After inpatient treatment, Nite2Day+ will deliver a six session (45-60 minutes), therapist-led, Zoom protocol. Participants will learn new mindfulness-based sleep strategies (e.g., sleep consolidation, sleep reconditioning), meditations (e.g., Sitting Meditation), and behavioral symptom coping skills. |
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| Usual Care | No Intervention | Participants will receive written materials describing free services (e.g., legal and financial assistance, counseling) available through the Duke Cancer Patient Support Program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nite2Day+ | Behavioral | Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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) |
| Feasibility as measured by adherence | Adherence will be indicated by at least 75% of study sessions and assessments completed. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hannah M Fisher, PhD | Contact | 919-416-3471 | hannah.fisher@duke.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
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| 2400 Pratt Street | Recruiting | Durham | North Carolina | 27705 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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/not at all) to 4 (almost always). Items are summed to yield a total score, with higher scores reflecting greater mindfulness. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |
| 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. | Baseline (0 weeks), Discharge (4 weeks), Post-Intervention (13 weeks), 1-month post-intervention (17 weeks) |