Back to resultsBody Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
Primary Purpose
Hematological Malignancy
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Body Scan
Rotterdam Symptom Checklist
Practice Logs
Sponsored by
About this trial
This is an interventional supportive care trial for Hematological Malignancy
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: Body Scan
Arm Description
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
Outcomes
Primary Outcome Measures
Measure of distress in patients measured by the RSCL scores
-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)
Measure of distress in caregivers measured by the RSCL scores
-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)
Secondary Outcome Measures
Frequency of body scan practice
-Practice Logs will be used to notate frequency of body scan practice
Full Information
NCT ID
NCT03611764
First Posted
July 19, 2018
Last Updated
October 29, 2018
Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03611764
Brief Title
Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
Official Title
The Mindfulness Pilot Project: The Effects of a Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Only 5 caregivers decided to participate
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Body Scan
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Body Scan
Intervention Description
-All efforts will be made to normalize their experience: for example, the desire to open their eyes, thinking about other things, wanting to move around - these are all normal and participants will be encouraged to become interested in and curious about, and to allow these natural tendencies
Intervention Type
Other
Intervention Name(s)
Rotterdam Symptom Checklist
Other Intervention Name(s)
RSCL
Intervention Description
39 Likert-scale items, including physical and psychological symptoms (30 questions), daily function (8 questions), and overall valuation of life (one question)
For the 30 questions pertaining to symptoms, the four-item Likert scale ranges from 'not at all=1' to 'very much=4'; the higher the total score, the greater the score, the higher the level of distress. The single question pertaining to overall valuation of life asks participants to circle one of the seven items, ranked from "extremely poor" to "excellent"
Intervention Type
Other
Intervention Name(s)
Practice Logs
Intervention Description
-Describe frequency of the Zen Den
Primary Outcome Measure Information:
Title
Measure of distress in patients measured by the RSCL scores
Description
-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)
Time Frame
Through 2 weeks
Title
Measure of distress in caregivers measured by the RSCL scores
Description
-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)
Time Frame
Through 2 weeks
Secondary Outcome Measure Information:
Title
Frequency of body scan practice
Description
-Practice Logs will be used to notate frequency of body scan practice
Time Frame
Through 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maggie Compernolle, BSN, RN
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
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