Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532773
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 paperpencil 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None