Clinical trial NCT05371847: Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity
Official title: Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: upper limb dysfunction
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Vrije Universiteit Brussel
First posted: 2022-05-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Reliability of measurements with MyotonPro
timeFrame: 1 week
measure: Validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer
timeFrame: 1 week
measure: Validity of palpation for general stiffness
timeFrame: 1 week
measure: Reliability for the assessment of movement functions
timeFrame: 1 week
measure: Construct validity for the assessment of movement functions
timeFrame: 1 week
measure: Validity of machine learning model for Upper limb functioning from ActiGraph sensors for breast cancer survivors
timeFrame: 1 week
measure: Validity of the use of hot/cold tubes for temperature sensations
timeFrame: 1 week
measure: Validity of the assessment of upper limb activities through accelerometry
timeFrame: 1 week
measure: Validity of the assessment of upper limb activities: quickDASH
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
Study officials:
affiliation: KU Leuven
name: An De Groef, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.