Body Scan Activity on Bone Marrow Transplant Patients and Their Caregivers

Hematological Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03611764
• Other study ID #: 201803060
• Status: Terminated
• Phase: Phase 1
• Start date: April 17, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: October 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: August 28, 2018
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hematological Malignancy

Intervention

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"
• Practice Logs
-Describe frequency of the Zen Den

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frequency of body scan practice	-Practice Logs will be used to notate frequency of body scan practice	Through 2 weeks

External Links

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