Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment
NCT ID: NCT05297591
Last Updated: 2024-05-01
Study Results
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Basic Information
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RECRUITING
250 participants
OBSERVATIONAL
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.
There is a need to rethink the follow-up strategy (besides the treatment of the cancer itself) and develop a clinical care pathway consisting of multifactorial screening instruments to identify women and men who are in need of extra rehabilitation efforts and specific rehabilitation goals to alleviate symptoms and side effects experienced by breast cancer survivors. This clinical care pathway should cover all aspects of the International Classification of Function, Disease and Health (ICF), a biopsychosocial framework that conceptualizes a person's level of functioning and bodily structures, activity and participation and contextual factors (including personal and environmental factors).
The present study aims to identify the factors, during and after breast cancer treatment, contributing to persistent Upper Limb (UL) dysfunctions.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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breast cancer patients
Women and men diagnosed with breast cancer waiting for surgery
assessment of UL function and prognostic factors
clinical assessments and questionnaires
Interventions
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assessment of UL function and prognostic factors
clinical assessments and questionnaires
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* And/or with a diagnosis of a neurological or rheumatological condition,
* And/or BCS who are not available the entire duration of the study
18 Years
ALL
No
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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Hidding JT, Beurskens CH, van der Wees PJ, van Laarhoven HW, Nijhuis-van der Sanden MW. Treatment related impairments in arm and shoulder in patients with breast cancer: a systematic review. PLoS One. 2014 May 9;9(5):e96748. doi: 10.1371/journal.pone.0096748. eCollection 2014.
Berry DA, Cronin KA, Plevritis SK, Fryback DG, Clarke L, Zelen M, Mandelblatt JS, Yakovlev AY, Habbema JD, Feuer EJ; Cancer Intervention and Surveillance Modeling Network (CISNET) Collaborators. Effect of screening and adjuvant therapy on mortality from breast cancer. N Engl J Med. 2005 Oct 27;353(17):1784-92. doi: 10.1056/NEJMoa050518.
De Groef A, Meeus M, De Vrieze T, Vos L, Van Kampen M, Christiaens MR, Neven P, Geraerts I, Devoogdt N. Pain characteristics as important contributing factors to upper limb dysfunctions in breast cancer survivors at long term. Musculoskelet Sci Pract. 2017 Jun;29:52-59. doi: 10.1016/j.msksp.2017.03.005. Epub 2017 Mar 14.
Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.
Ustun TB, Chatterji S, Bickenbach J, Kostanjsek N, Schneider M. The International Classification of Functioning, Disability and Health: a new tool for understanding disability and health. Disabil Rehabil. 2003 Jun 3-17;25(11-12):565-71. doi: 10.1080/0963828031000137063.
Yang EJ, Kim BR, Shin HI, Lim JY. Use of the international classification of functioning, disability and health as a functional assessment tool for breast cancer survivors. J Breast Cancer. 2012 Mar;15(1):43-50. doi: 10.4048/jbc.2012.15.1.43. Epub 2012 Mar 28.
De Groef A, Vets N, Devoogdt N, Smeets A, Van Assche D, Emmerzaal J, Dams L, Verbeelen K, Fieuws S, Baets L. Prognostic factors for the development of upper limb dysfunctions after breast cancer: the UPLIFT-BC prospective longitudinal cohort study protocol. BMJ Open. 2024 May 15;14(5):e084882. doi: 10.1136/bmjopen-2024-084882.
Other Identifiers
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s66248
Identifier Type: -
Identifier Source: org_study_id
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