Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04736056
Status:
COMPLETED
Last Update Posted:
2023-05-26
First Post:
2021-01-29
Brief Title:
Mindfulness and CBT for Sleep
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy Poor sleep quality can contribute to and perpetuate problems with daytime fatigue pain and distress that are common among patients with hematologic cancer There is a need for behavioral interventions that address insomnia and daytime fatigue pain and distress once hematologic cancer patients have returned home after inpatient chemotherapy Mindfulness-Based Therapy for Insomnia MBTI is a new approach to treating insomnia This group-based intervention combines sleep restriction and stimulus control with mindfulness principles and exercises to reduce worry and promote positive responses to insomnia To date MBTI has not been applied to patients with hematologic cancer If MBTI is to meet the needs of hematologic cancer patients it must be adapted in several ways First because hematologic cancer patients are immunosuppressed MBTI needs to be adapted for one-to-one delivery Second because hematologic cancer patients experience significant daytime fatigue pain and distress MBTI needs to be adapted to include systematic training in coping skills for these symptoms The investigators propose to develop and pilot test an adapted MBTI MBTI protocol for hematologic cancer patients reporting insomnia fatigue pain andor distress after inpatient chemotherapy The study will be conducted in two phases In Phase I the study team will use focus groups with hematologic cancer patients and hematology-oncology providers to guide development along with user testing with hematologic cancer patients reporting insomnia and daytime symptoms of fatigue pain andor distress Phase II will involve a small single-arm pilot to examine the feasibility acceptability and examine pre- to post-intervention primary insomnia and secondary fatigue pain distress mindfulness self-efficacy outcomes of the MBTI protocol MBTI will consist of six 60- to 75-minute therapy sessions delivered either in-person or via videoconferencing technology Study measures will be collected at baseline immediately post-intervention and 1-month post-intervention
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None