Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity
NCT ID: NCT05371847
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2022-04-26
2025-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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breast cancer patients
Women and men in the prospective cohort study will be invited to participate in this additional validity and/or reliability testing
assessment for upper limb dysfunction
clinical assessments and questionnaires
retest assessment
For the test-retest reliability testing, participants will be invited to have an additional appointment approximately 1 week after the main assessment.
healthy volunteers
age- and gender-matched
assessment for upper limb dysfunction
clinical assessments and questionnaires
retest assessment
For the test-retest reliability testing, participants will be invited to have an additional appointment approximately 1 week after the main assessment.
Interventions
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assessment for upper limb dysfunction
clinical assessments and questionnaires
retest assessment
For the test-retest reliability testing, participants will be invited to have an additional appointment approximately 1 week after the main assessment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* History of breast cancer
* Patients with a diagnosis of neurological or rheumatological condition, diabetes
18 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Vrije Universiteit Brussel
OTHER
KU Leuven
OTHER
Responsible Party
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An De Groef
Prof. Dr
Principal Investigators
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An De Groef, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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Universitair Ziekenhuis Leuven
Leuven, , Belgium
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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s66248-aim2
Identifier Type: -
Identifier Source: org_study_id
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