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Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers

Sponsor
Washington University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT03611764
Collaborator
Barnes-Jewish Hospital (Other)
37
Enrollment
1
Location
1
Arm
4.4
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Body Scan
  • Other: Rotterdam Symptom Checklist
  • Other: Practice Logs
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Mindfulness Pilot Project: The Effects of a Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers
Actual Study Start Date :
Apr 17, 2018
Actual Primary Completion Date :
Aug 28, 2018
Actual Study Completion Date :
Aug 28, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Body Scan

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

Behavioral: Body Scan
-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

Other: Rotterdam Symptom Checklist
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"
Other Names:
  • RSCL

    • Other: Practice Logs
    -Describe frequency of the Zen Den

    Outcome Measures

    Primary Outcome Measures

    1. Measure of distress in patients measured by the RSCL scores [Through 2 weeks]

      -Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)

    2. Measure of distress in caregivers measured by the RSCL scores [Through 2 weeks]

      -Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)

    Secondary Outcome Measures

    1. Frequency of body scan practice [Through 2 weeks]

      -Practice Logs will be used to notate frequency of body scan practice

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63110

    Sponsors and Collaborators

    • Washington University School of Medicine
    • Barnes-Jewish Hospital

    Investigators

    • Principal Investigator: Maggie Compernolle, BSN, RN, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT03611764
    Other Study ID Numbers:
    • 201803060
    First Posted:
    Aug 2, 2018
    Last Update Posted:
    Oct 31, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Oct 31, 2018