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Improving Patient Experience: BMBA

Primary Purpose

Bone Marrow Cancer, Leukemia, Lymphoma

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual reality

Environmental changes

About this trial

This is an interventional supportive care trial for Bone Marrow Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Provide signed and dated informed consent form Willing to comply with all study procedures Over 18 years of age Prior history of at least 1 (one) BMBA at Jefferson outpatient oncology office within the past 2 (two) years Visiting the Jefferson outpatient oncology office for a BMBA procedure during the study duration Exclusion Criteria: Inability to read questions in English Inability to answer questions autonomously History of vertigo Legal blindness in both eyes Severe or profound hearing loss, or deafness

Sites / Locations

Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Intervention 1: Virtual reality

Control 1

Intervention 2: Environmental changes

Control 2

Arm Description

Standard of care without change, in parallel with intervention 1: Virtual reality.

Standard of care without change, in parallel with intervention 2: Environmental changes.

Outcomes

Primary Outcome Measures

Distress score

The primary outcome will be reported on a scale of 0-10, based on the National Comprehensive Cancer Network (NCCN) Distress Thermometer, 0 signifying "no distress" and 10 signifying "extreme distress." This scale is standardly used with oncology patients to determine their distress levels-distress refers to "an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment."

Distress score

Secondary Outcome Measures

Pain intensity

To assess patient pain scores related to their BMBA procedure. This will be measured through the 0-10 Numeric Pain Intensity Scale, 0 signifying "no pain" and 10 signifying "the worst pain imaginable."

Pain intensity

Patient satisfaction

To assess patient satisfaction with their procedure. This will be assessed through a patient satisfaction survey including Likert-type questions.

Full Information

NCT ID

NCT05690230

First Posted

December 21, 2022

Last Updated

January 9, 2023

Sponsor

Thomas Jefferson University

Collaborators

Daisy Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05690230

Brief Title

Improving Patient Experience: BMBA

Official Title

Improving the Patient Experience During Bone Marrow Biopsy/Aspiration (BMBA): Do Interventions Decrease Distress and Pain

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

December 5, 2022 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thomas Jefferson University

Collaborators

Daisy Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study seeks to determine if patients undergoing a bone marrow biopsy/aspiration (BMBA) procedure who receive distraction techniques have lower levels of distress and pain, and higher post-procedure satisfaction, compared to those receiving standard-of-care. Intervention 1 is guided meditation in a virtual reality (VR) headset. Intervention 2 is comprised of environmental changes to the room (via nature-themed decals) and music.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bone Marrow Cancer, Leukemia, Lymphoma, Multiple Myeloma, Hematologic Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two interventions will be trialed, each in parallel with a control group. The two phases will be done in sequence.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention 1: Virtual reality

Arm Type

Experimental

Arm Title

Control 1

Arm Type

No Intervention

Arm Description

Standard of care without change, in parallel with intervention 1: Virtual reality.

Arm Title

Intervention 2: Environmental changes

Arm Type

Experimental

Arm Title

Control 2

Arm Type

No Intervention

Arm Description

Standard of care without change, in parallel with intervention 2: Environmental changes.

Intervention Type

Other

Intervention Name(s)

Virtual reality

Intervention Description

Patients will be provided with a wireless virtual reality headset that contains a guided meditation application. The application allows users to select their preferred music, visual setting, and a topic for meditation.

Intervention Type

Other

Intervention Name(s)

Environmental changes

Intervention Description

A nature themed wall mural decal will be installed in the procedure room and the in-room computer will play music from Pandora. A selection of suggested stations will be provided, with the option for outside selections.

Primary Outcome Measure Information:

Title

Distress score

Description

Time Frame

Within 10 minutes pre-procedure

Title

Distress score

Description

Time Frame

Within 10 minutes post-procedure

Secondary Outcome Measure Information:

Title

Pain intensity

Description

Time Frame

Within 10 minutes pre-procedure

Title

Pain intensity

Description

Time Frame

Within 10 minutes post-procedure

Title

Patient satisfaction

Description

To assess patient satisfaction with their procedure. This will be assessed through a patient satisfaction survey including Likert-type questions.

Time Frame

Within 10 minutes post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Links:

URL

https://www.nccn.org/docs/default-source/patient-resources/nccn_distress_thermometer.pdf?sfvrsn=ef1df1a2_4

Description

NCCN Distress Thermometer and Problem List for Patients

URL

https://www.meta.com/legal/quest/health-and-safety-warnings/

Description

Oculus Go warnings

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Improving Patient Experience: BMBA

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