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Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises

Primary Purpose

Breast Cancer, Lymphedema

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kinect-TOLF Training System
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women who have received surgical treatment for breast cancer (Stage I-III), including mastectomy, lumpectomy, sentinel lymph node biopsy (SLNB), SLNB plus lymph node dissection or axillary lymph nodes dissection
  • Report any persistent or intermittent pain or lymphedema symptoms in the ipsilateral upper limb or body at least 8 weeks after surgery, that is, beyond the expected period of healing
  • May or may not have had neoadjuvant therapy or adjuvant therapy of chemotherapy or radiation
  • Have history or no history of lymphedema or have or not been treated for lymphedema;
  • Able to speak and understand English since the proposed usability testing is designed to only test the English version of the intervention.
  • Women willing to come to the NYU Perlmutter Cancer Center for the research visit.

Exclusion Criteria:

  • Women diagnosed with breast cancer but did not undergo surgical treatment as breast surgery and removal of lymph nodes are the major treatment-related risk factors for lymphedema;
  • Known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions;
  • Women with renal or heart failure, cardiac pacemaker or defibrillator, artificial limbs, or pregnant women as accurate measurement of body mass index (BMI) may not be possible with an impedance device according to the manufactures.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kinect-TOLF prototype

Arm Description

Outcomes

Primary Outcome Measures

The Perceived Ease of Use and Usefulness
a tool to evaluate users' acceptance of a new information system with a strong reliability for perceived usefulness and perceived ease of use [49-50]. We used the modified eight-items with 5-point Likert Scales ranging from 2 (strongly agree) to -2 (strongly disagree) for this usability evaluation.
The Post Study System Usability Questionnaire
originally is a 19-item survey instrument developed at IBM to assess user satisfaction with system usability on a scale ranging from 1 (strongly agree) to 7 (strongly disagree). We will use the modified 13-item tool from the original survey that focus on system usefulness and information quality (Lewis 1995). The survey consists of three subscales accounted for 87 percent of the total variance: system usefulness, information quality and interface quality. The overall reliability of the survey was 0.97, and ranged from 0.91 to 0.96 for the three subscales.

Secondary Outcome Measures

Full Information

First Posted
June 24, 2019
Last Updated
July 9, 2020
Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03999177
Brief Title
Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises
Official Title
Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Correct performance of therapeutic lymphatic exercises has the potential to relieve lymphedema symptoms and optimize limb volume and lymph fluid level, in turn to improve breast cancer survivors' quality of life and reduce the risk of lymphedema. Kinect-TOLF (Kinect-Enhanced The-Optimal-Lymph-Flow Training System) is an innovative intelligent Kinect-enhanced training system to teach patients to perform the lymphatic exercises correctly. The Kinect-TOLF training system is not a medical device but a computer/mobile and motion-sensor program that helps patients to perform the lymphatic exercises correctly. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. The goal of the proposed project is to evaluate the usability and feasibility of Kinect-TOLF.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinect-TOLF prototype
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Kinect-TOLF Training System
Intervention Description
This system will teach patients to perform the lymphatic exercises correctly. Like playing the video games, patients follow the avatar model in the video to perform the lymphatic exercises. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. Patients will be asked to conduct two types of usability testing: heuristic evaluation and end-user testing.
Primary Outcome Measure Information:
Title
The Perceived Ease of Use and Usefulness
Description
a tool to evaluate users' acceptance of a new information system with a strong reliability for perceived usefulness and perceived ease of use [49-50]. We used the modified eight-items with 5-point Likert Scales ranging from 2 (strongly agree) to -2 (strongly disagree) for this usability evaluation.
Time Frame
12 Months
Title
The Post Study System Usability Questionnaire
Description
originally is a 19-item survey instrument developed at IBM to assess user satisfaction with system usability on a scale ranging from 1 (strongly agree) to 7 (strongly disagree). We will use the modified 13-item tool from the original survey that focus on system usefulness and information quality (Lewis 1995). The survey consists of three subscales accounted for 87 percent of the total variance: system usefulness, information quality and interface quality. The overall reliability of the survey was 0.97, and ranged from 0.91 to 0.96 for the three subscales.
Time Frame
12 Months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who have received surgical treatment for breast cancer (Stage I-III), including mastectomy, lumpectomy, sentinel lymph node biopsy (SLNB), SLNB plus lymph node dissection or axillary lymph nodes dissection Report any persistent or intermittent pain or lymphedema symptoms in the ipsilateral upper limb or body at least 8 weeks after surgery, that is, beyond the expected period of healing May or may not have had neoadjuvant therapy or adjuvant therapy of chemotherapy or radiation Have history or no history of lymphedema or have or not been treated for lymphedema; Able to speak and understand English since the proposed usability testing is designed to only test the English version of the intervention. Women willing to come to the NYU Perlmutter Cancer Center for the research visit. Exclusion Criteria: Women diagnosed with breast cancer but did not undergo surgical treatment as breast surgery and removal of lymph nodes are the major treatment-related risk factors for lymphedema; Known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions; Women with renal or heart failure, cardiac pacemaker or defibrillator, artificial limbs, or pregnant women as accurate measurement of body mass index (BMI) may not be possible with an impedance device according to the manufactures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Fu, PhD, RN, FAAN
Organizational Affiliation
New York Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34160294
Citation
Fu MR, McTernan ML, Qiu JM, Ko E, Yazicioglu S, Axelrod D, Guth A, Fan Z, Sang A, Miaskowski C, Wang Y. The Effects of Kinect-Enhanced Lymphatic Exercise Intervention on Lymphatic Pain, Swelling, and Lymph Fluid Level. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211026757. doi: 10.1177/15347354211026757.
Results Reference
derived

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Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises

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