Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04736056
The ClinicalTrials.gov registry entry for NCT04736056 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 227-participant average among 48 other Hematologic Malignancy trials with a reported enrollment target (75% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Hematologic Malignancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Let's Get REAL: Family Health Communication Tool in Pediatric Stem Cell Transplant and Cellular Therapy
RECRUITING · NA
-
Implementation of an Oral Chemotherapy Adherence Intervention
RECRUITING · NA
-
ONC-MM-2407: The Effect of Virtual Reality Headsets on Pain and Anxiety in the Peri and Post Bone Marrow Biopsy Period
RECRUITING · NA
-
BMT-CARE: Psychosocial Intervention for Transplant Caregivers
RECRUITING · NA
-
Mindfulness Intervention for Sleep Disturbance and Symptom Management in Hematologic Cancer Patients During and After Inpatient Treatment
RECRUITING · NA
-
HEME Home Transfusion Program
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.