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Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity (UPLIFT-BC)

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
assessment for upper limb dysfunction
retest assessment
Sponsored by
KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring upper limb dysfunction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for breast cancer patients

  • Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer.
  • Patients who receive adjuvant radiotherapy .
  • Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant
  • Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent

Inclusion criteria healthy volunteers

  • Healthy women and men(quickDASH<15) age- and gender-matched with a breast cancer patient from the main study
  • Volunteers who can comply with the protocol at baseline assessment and willing to provide written informed consent

Exclusion Criteria breast cancer patients

  • BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery
  • And/or with a diagnosis of a neurological or rheumatological condition, diabetes,
  • And/or BCS who are not available the entire duration of the study

Exclusion Criteria healthy volunteers

  • History of breast cancer
  • Patients with a diagnosis of neurological or rheumatological condition, diabetes

Sites / Locations

  • Universitair Ziekenhuis LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

breast cancer patients

healthy volunteers

Arm Description

Women and men in the prospective cohort study will be invited to participate in this additional validity and/or reliability testing

age- and gender-matched

Outcomes

Primary Outcome Measures

Reliability of measurements with MyotonPro
Inter- and intra-rater reliability will be tested. The MyotonPRO assessment for soft-tissue stiffness and elasticity will take place at the pectoralis major, upper trapezius, infraspinatus and teres major region, from which a mean stiffness index (N/m) will be calculated. approximately 1 week between test & retest
Validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer
The validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer (MAP-BC evaluation tool), developed during PhD project of Prof. An De Groef will be investigated. This clinical assessment tool consists of the assessment of soft-tissue adhesion at 7 locations at the upper limb region: axillary and breast region scars, pectoral region, axilla, frontal chest wall, lateral chest wall and the inframammary fold. At each location, the degree of the adhesions will be scored at three levels (skin, superficial and deep) on a 4-point scale (between no adhesions and very stiff adhesions). results will be compared with the results of the Myoton pro. approximately 1 week between test & retest
Validity of palpation for general stiffness
Palpation for general tissue stiffness scored on a Linkert Scale (0-5) at the different locations will be explored and the sum of total score of all locations will be calculated (0-35). results will be compared with the results of the Myoton pro. approximately 1 week between test & retest
Reliability for the assessment of movement functions
The reliability of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer. The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer. approximately 1 week between test & retest
Construct validity for the assessment of movement functions
The validity of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer. The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer. approximately 1 week between test & retest
Validity of machine learning model for Upper limb functioning from ActiGraph sensors for breast cancer survivors
The accelerometer to evaluate upper limb functioning will be validated against video annotated data as proposed by Lum and colleagues. Established methods use a machine learning pipeline to accurately and automatically recognize functional upper limb activities from accelerometer data in healthy subjects. These models will be evaluated against video annotated data to assess accuracy and correlation for our subsample of breast cancer survivors. approximately 1 week between test & retest
Validity of the use of hot/cold tubes for temperature sensations
Hot/cold tubes will be used for the cold and heat detection, but to validate this assessment method is will be compared with thermorollers. approximately 1 week between test & retest
Validity of the assessment of upper limb activities through accelerometry
The accelerometer will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model. approximately 1 week between test & retest
Validity of the assessment of upper limb activities: quickDASH
The quickDASH will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model. The QuickDASH is a shortened version of the DASH Outcome Measure. The QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability approximately 1 week between test & retest

Secondary Outcome Measures

Full Information

First Posted
March 17, 2022
Last Updated
February 7, 2023
Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven, Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT05371847
Brief Title
Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity
Acronym
UPLIFT-BC
Official Title
Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
Collaborators
Universitaire Ziekenhuizen KU Leuven, Vrije Universiteit Brussel

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
Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment. The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment. This study aims to find reliable and valid assessment methods for the prognostic factors and upper limb function itself in a small group of BCS and healthy volunteers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
upper limb dysfunction

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
breast cancer patients
Arm Type
Active Comparator
Arm Description
Women and men in the prospective cohort study will be invited to participate in this additional validity and/or reliability testing
Arm Title
healthy volunteers
Arm Type
Active Comparator
Arm Description
age- and gender-matched
Intervention Type
Other
Intervention Name(s)
assessment for upper limb dysfunction
Intervention Description
clinical assessments and questionnaires
Intervention Type
Other
Intervention Name(s)
retest assessment
Intervention Description
For the test-retest reliability testing, participants will be invited to have an additional appointment approximately 1 week after the main assessment.
Primary Outcome Measure Information:
Title
Reliability of measurements with MyotonPro
Description
Inter- and intra-rater reliability will be tested. The MyotonPRO assessment for soft-tissue stiffness and elasticity will take place at the pectoralis major, upper trapezius, infraspinatus and teres major region, from which a mean stiffness index (N/m) will be calculated. approximately 1 week between test & retest
Time Frame
1 week
Title
Validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer
Description
The validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer (MAP-BC evaluation tool), developed during PhD project of Prof. An De Groef will be investigated. This clinical assessment tool consists of the assessment of soft-tissue adhesion at 7 locations at the upper limb region: axillary and breast region scars, pectoral region, axilla, frontal chest wall, lateral chest wall and the inframammary fold. At each location, the degree of the adhesions will be scored at three levels (skin, superficial and deep) on a 4-point scale (between no adhesions and very stiff adhesions). results will be compared with the results of the Myoton pro. approximately 1 week between test & retest
Time Frame
1 week
Title
Validity of palpation for general stiffness
Description
Palpation for general tissue stiffness scored on a Linkert Scale (0-5) at the different locations will be explored and the sum of total score of all locations will be calculated (0-35). results will be compared with the results of the Myoton pro. approximately 1 week between test & retest
Time Frame
1 week
Title
Reliability for the assessment of movement functions
Description
The reliability of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer. The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer. approximately 1 week between test & retest
Time Frame
1 week
Title
Construct validity for the assessment of movement functions
Description
The validity of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer. The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer. approximately 1 week between test & retest
Time Frame
1 week
Title
Validity of machine learning model for Upper limb functioning from ActiGraph sensors for breast cancer survivors
Description
The accelerometer to evaluate upper limb functioning will be validated against video annotated data as proposed by Lum and colleagues. Established methods use a machine learning pipeline to accurately and automatically recognize functional upper limb activities from accelerometer data in healthy subjects. These models will be evaluated against video annotated data to assess accuracy and correlation for our subsample of breast cancer survivors. approximately 1 week between test & retest
Time Frame
1 week
Title
Validity of the use of hot/cold tubes for temperature sensations
Description
Hot/cold tubes will be used for the cold and heat detection, but to validate this assessment method is will be compared with thermorollers. approximately 1 week between test & retest
Time Frame
1 week
Title
Validity of the assessment of upper limb activities through accelerometry
Description
The accelerometer will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model. approximately 1 week between test & retest
Time Frame
1 week
Title
Validity of the assessment of upper limb activities: quickDASH
Description
The quickDASH will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model. The QuickDASH is a shortened version of the DASH Outcome Measure. The QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability approximately 1 week between test & retest
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for breast cancer patients Patients scheduled for surgery (mastectomy or breast conserving surgery; in combination with axillary lymph node dissection or sentinel node biopsy) for unilateral primary breast cancer or patients with oligometastatic breast cancer. Patients who receive adjuvant radiotherapy . Patients with a cognitive and language functioning enabling coherent Dutch communication between the examiner and the participant Patients who can comply with the protocol at baseline assessment and willing to provide written informed consent Inclusion criteria healthy volunteers Healthy women and men(quickDASH<15) age- and gender-matched with a breast cancer patient from the main study Volunteers who can comply with the protocol at baseline assessment and willing to provide written informed consent Exclusion Criteria breast cancer patients BCS with widespread distance metastases, previous breast surgery, or planned bilateral surgery And/or with a diagnosis of a neurological or rheumatological condition, diabetes, And/or BCS who are not available the entire duration of the study Exclusion Criteria healthy volunteers History of breast cancer Patients with a diagnosis of neurological or rheumatological condition, diabetes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
An De Groef, Prof. Dr.
Phone
003216376668
Email
an.degroef@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Nieke Vets
Email
nieke.vets@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An De Groef, Prof. Dr.
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An De Groef, Prof
Phone
+3216376668
Email
an.degroef@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Nieke Vets, PhD
Email
nieke.vets@kuleuven.be

12. IPD Sharing Statement

Citations:
PubMed Identifier
32772650
Citation
De Groef A, Van der Gucht E, Dams L, Evenepoel M, Teppers L, Toppet-Hoegars J, De Baets L. The association between upper limb function and variables at the different domains of the international classification of functioning, disability and health in women after breast cancer surgery: a systematic review. Disabil Rehabil. 2022 Apr;44(8):1176-1189. doi: 10.1080/09638288.2020.1800835. Epub 2020 Aug 8.
Results Reference
background
PubMed Identifier
28598978
Citation
De Groef A, Van Kampen M, Vervloesem N, De Geyter S, Dieltjens E, Christiaens MR, Neven P, Geraerts I, Devoogdt N. An evaluation tool for myofascial adhesions in patients after breast cancer (MAP-BC evaluation tool): Development and interrater reliability. PLoS One. 2017 Jun 9;12(6):e0179116. doi: 10.1371/journal.pone.0179116. eCollection 2017.
Results Reference
background
PubMed Identifier
19924721
Citation
Yang EJ, Park WB, Seo KS, Kim SW, Heo CY, Lim JY. Longitudinal change of treatment-related upper limb dysfunction and its impact on late dysfunction in breast cancer survivors: a prospective cohort study. J Surg Oncol. 2010 Jan 1;101(1):84-91. doi: 10.1002/jso.21435.
Results Reference
background
PubMed Identifier
22286332
Citation
Kilbreath SL, Refshauge KM, Beith JM, Ward LC, Lee M, Simpson JM, Hansen R. Upper limb progressive resistance training and stretching exercises following surgery for early breast cancer: a randomized controlled trial. Breast Cancer Res Treat. 2012 Jun;133(2):667-76. doi: 10.1007/s10549-012-1964-1.
Results Reference
background
PubMed Identifier
33150830
Citation
Lum PS, Shu L, Bochniewicz EM, Tran T, Chang LC, Barth J, Dromerick AW. Improving Accelerometry-Based Measurement of Functional Use of the Upper Extremity After Stroke: Machine Learning Versus Counts Threshold Method. Neurorehabil Neural Repair. 2020 Dec;34(12):1078-1087. doi: 10.1177/1545968320962483. Epub 2020 Nov 5.
Results Reference
background

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Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity

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