Clinical trial NCT05297591: Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment
Official title: Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
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: 2022-03-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohort will be selected from the population of breast cancer patients at the University Hospital Leuven

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.

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.


Eligibility criteria: Inclusion Criteria:

* 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 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:

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

Primary outcomes:
measure: Subjective upper limb function
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Objective upper limb function
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of presence of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of pain intensity
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of presence of neuropathic pain
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of presence of sensory loss
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of presence of widespread pain
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of impact of pain on functioning
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Soft tissue stiffness index
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Total relative arm volume (%)
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of movement functions during a functional task
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Upper limb muscle strength (kg)
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Pain catastrophizing
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Self-efficacy
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Depression, Anxiety and Stress
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Fear of movement
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Body-perception
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of Quality of Life
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of (Sub)optimal physical therapy care
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of treatment with Chemotherapy
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of treatment with Hormone therapy
timeFrame: Time frame up to 6 months post-radiotherapy
measure: Prognostic value of soft tissue adhesions
timeFrame: Time frame up to 6 months post-radiotherapy
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:
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citation: 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.