Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers

NCT03611764 | Terminated Phase 1

• 1 other identifier: 201803060
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Malignancy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Frequency of body scan practice

  Through 2 weeks

Study Arms (1)

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

Behavioral: Body Scan; Other: Rotterdam Symptom Checklist; Other: Practice Logs

Interventions

Body Scan BEHAVIORAL

-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

Arm 1: Body Scan

Rotterdam Symptom Checklist OTHER

* 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"

Also known as: RSCL

Arm 1: Body Scan

Practice Logs OTHER

-Describe frequency of the Zen Den

Arm 1: Body Scan

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary \& self-selected patients and caregivers
• Located on the leukemia/lymphoma/bone marrow transplant floor at Barnes Jewish Hospital

You may not qualify if:

• Patients requiring a language translator or interpreter will be excluded from the study

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Whole Body Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Maggie Compernolle, BSN, RN

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 2, 2018
• Study Start: April 17, 2018
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: October 31, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)