NCT03611764TerminatedPhase 1
The Mindfulness Pilot Project: The Effects of a Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
Washington University School of Medicine2 sites in 1 country37 target enrollmentStarted: April 17, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Measure of distress in caregivers measured by the RSCL scores
Study Overview
Brief Summary
This study will address whether teaching the Body Scan exercise to cancer patients with hematological malignancies and their caregivers during an inpatient hospitalization improves reported physical and psychological symptoms after a two-week period. Giving patients and caregivers the opportunity to learn mindfulness and the tools to practice on their own is expected to lead to a decrease in stress and anxiety, and help empower patients and caregivers to better cope with stress in the future.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Voluntary & self-selected patients and caregivers
- •Located on the leukemia/lymphoma/bone marrow transplant floor at Barnes Jewish Hospital
Exclusion Criteria
- •Patients requiring a language translator or interpreter will be excluded from the study
Arms & Interventions
Arm 1: Body Scan
Experimental
- The mindfulness-based intervention (MBI) of the Body Scan is expected to take 20 minutes
- Participants will then be guided through the Body Scan. Beginning with awareness of sensations of the left toe, patients will be asked to observe these sensations without judgment, simply noticing and allowing them. Awareness of sensations will continue up through the left leg, then from the right toe up the right leg, then abdomen and chest, then fingertips to arms, then neck, and finally the head. After completing the Body Scan, participants will be given several minutes of quiet to reflect upon how they feel. After opening their eyes, participants will be given the opportunity to discuss and ask questions.
- Caregivers will be encouraged to practice with the patient or on their own, in an additional space on the floor called the Zen Den
Intervention: Body Scan (Behavioral)
Arm 1: Body Scan
Experimental
- The mindfulness-based intervention (MBI) of the Body Scan is expected to take 20 minutes
- Participants will then be guided through the Body Scan. Beginning with awareness of sensations of the left toe, patients will be asked to observe these sensations without judgment, simply noticing and allowing them. Awareness of sensations will continue up through the left leg, then from the right toe up the right leg, then abdomen and chest, then fingertips to arms, then neck, and finally the head. After completing the Body Scan, participants will be given several minutes of quiet to reflect upon how they feel. After opening their eyes, participants will be given the opportunity to discuss and ask questions.
- Caregivers will be encouraged to practice with the patient or on their own, in an additional space on the floor called the Zen Den
Intervention: Rotterdam Symptom Checklist (Other)
Arm 1: Body Scan
Experimental
- The mindfulness-based intervention (MBI) of the Body Scan is expected to take 20 minutes
- Participants will then be guided through the Body Scan. Beginning with awareness of sensations of the left toe, patients will be asked to observe these sensations without judgment, simply noticing and allowing them. Awareness of sensations will continue up through the left leg, then from the right toe up the right leg, then abdomen and chest, then fingertips to arms, then neck, and finally the head. After completing the Body Scan, participants will be given several minutes of quiet to reflect upon how they feel. After opening their eyes, participants will be given the opportunity to discuss and ask questions.
- Caregivers will be encouraged to practice with the patient or on their own, in an additional space on the floor called the Zen Den
Intervention: Practice Logs (Other)
Outcomes
Primary Outcomes
Measure of distress in caregivers measured by the RSCL scores
Time Frame: Through 2 weeks
-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)
Measure of distress in patients measured by the RSCL scores
Time Frame: Through 2 weeks
-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)
Secondary Outcomes
- Frequency of body scan practice(Through 2 weeks)
Investigators
Study Sites (2)
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