Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers

The Mindfulness Pilot Project: The Effects of a Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers

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 Overview

• Status: Terminated
• Conditions: Hematological Malignancy
• Intervention / Treatment: Behavioral: Body Scan; Other: Rotterdam Symptom Checklist; Other: Practice Logs

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of distress in patients measured by the RSCL scores	-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)	Through 2 weeks
Measure of distress in caregivers measured by the RSCL scores	-Inferential statistics will be used to analyze the Rotterdam Symptom Checklist (RSCL)	Through 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of body scan practice	-Practice Logs will be used to notate frequency of body scan practice	Through 2 weeks

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Barnes-Jewish Hospital
• Investigators: Principal Investigator: Maggie Compernolle, BSN, RN, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2018
• Primary Completion (ACTUAL): August 28, 2018
• Study Completion (ACTUAL): August 28, 2018

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (ACTUAL): August 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 201803060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No