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NCT04736056 · ClinicalTrials.gov registry record · NA
Mindfulness and CBT for Sleep
A NA study of Hematologic Malignancy, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT04736056: Completed NA study of Hematologic Malignancy, sponsored by Duke University.
NCT04736056 is a NA study of Hematologic Malignancy that has completed, run by Duke University. The registered enrollment target is 57 participants, below the 227-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04736056, a NA study of Hematologic Malignancy, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study 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, and/or 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, and/or 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. MBT
Primary Outcome
Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot).
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Study Locations (1)
North Carolina
- Duke Cancer Institute - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2023-05-19 |
| Phase | NA |
What the finished NCT04736056 record still lists
NCT04736056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 227-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Hematologic Malignancy appearing as the primary indexed condition, and to 1 intervention - of which Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills is the first listed.
NCT04736056 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04736056 about?
NCT04736056 is a clinical study titled "Mindfulness and CBT for Sleep". 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 canc...
What is the current status of trial NCT04736056?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2021-04-01. Estimated completion is 2023-05-19.
What conditions does trial NCT04736056 study?
This clinical trial studies the following conditions: Hematologic Malignancy.
What interventions are being tested in trial NCT04736056?
The interventions under investigation include: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (BEHAVIORAL).
Who is sponsoring clinical trial NCT04736056?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04736056 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04736056's enrollment target sits among peer trials
57 25th of 48 higher than 24 of 48 other Hematologic Malignancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Malignancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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