Breast CancerUPLIFT-BCNCT05297591
Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment
An observational study of Breast Cancer, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- assessment of UL function and prognostic factors
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Apr 2022to Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The cohort will be selected from the population of breast cancer patients at the University Hospital Leuven
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nieke Vets contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
An De Groef, Prof, +3216376668, an.degroef@kuleuven.be
Nieke Vets, PhD, nieke.vets@kuleuven.be
About this study
Official title: Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
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.
Read more
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.
- Conditions
- Breast Cancer
- Being tested
- assessment of UL function and prognostic factors
- Keywords
- upper limb dysfunction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of UL function and prognostic factorsOther
clinical assessments and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| breast cancer patients | Women and men diagnosed with breast cancer waiting for surgery Receives: Other: assessment of UL function and prognostic factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective upper limb function
quickDASH (0-100) questionnaire: An abbreviated version of the original DASH (Disabilities of the Arm, Shoulder and Hand) outcome measure. The questionnaire contains 11 items that measures an individual's ability to complete tasks, absorb forces and severity of symptoms, with a 5-point Linkert scale.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Objective upper limb function
Accelerometry: duration of upper limb use (hours) during one week.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of presence of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities
Basic inspection of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of pain intensity
Numeric Rating Scale (0-10) of pain intensity during movement during the week before assessment.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of presence of neuropathic pain
Presence of neuropathic pain (yes/no):
Douleur Neuropathique en 4 questions (DN4) is a questionnaire generated for identifying pain of predominantly neuropathic origin. The DN4 consists of 7 self-reporting questions and 3 clinical examinations. A scoring of ≥4/10 is considered as a positive result for neuropathic pain.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of presence of sensory loss
Presence of sensory loss (yes/no) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of presence of widespread pain
Presence of widespread pain (yes/no)
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of impact of pain on functioning
Brief Pain Inventory: the short version assesses the the impact of the pain on functioning.The Brief Pain Inventory is a valid multimodal scale for assessing pain in breast cancer patients.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Soft tissue stiffness index
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.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Total relative arm volume (%)
Relative arm volume: Bilateral circumferential measurements using a perimeter will be performed.
Water displacement method hand: Bilateral water displacement method using a volumeter filled with water and allowed to settle at room temperature will be performed.
Afterwards the total volume (mL) can be calculated by taking the sum of the two measurements.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of movement functions during a functional task
The 3D scapulothoracic and glenohumeral movements will be assessed using inertial sensors (MTw motion capture, Xsens Technologies, The Netherlands) at the endpoint (i.e. point of task achievement) of the performance of a functional task, the Upper Limb Function Test (ULIFT), which is a valid and reliable test to assess upper limb functionality in breast cancer patients.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Upper limb muscle strength (kg)
A hand-held dynamometer will be used to assess handgrip strength
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Pain catastrophizing
Pain Catastrophizing Scale (0-52) : It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Self-efficacy
General Self-Efficacy Scale:This scale is a self-report measure of self-efficacy with 10 items (scored from 1-4). The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Depression, Anxiety and Stress
Depression, Anxiety and Stress Scale (DASS-21) (range 0-132). The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Fear of movement
Adjusted 11-item Tampa Scale of Kinesiophobia. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Thus, total scores range from 11-44 points with higher scores indicating greater fear of pain, movement, and injury
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Body-perception
A self-developed Dutch version of the Fremantle Shoulder Awareness Questionnaire will be used.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of Quality of Life
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). The QLQ-C30 is a validated questionnaire that incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of (Sub)optimal physical therapy care
Through a self-developed questionnaire, patients will be questioned whether they received no/suboptimal/optimal physical therapy care
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of treatment with Chemotherapy
no/taxanes/non-taxanes and neo-adjuvant/adjuvant (derived from the medical file) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of treatment with Hormone therapy
no/aromatase inhibitor/no-aromatase inhibitor (derived from the medical file)
Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Prognostic value of soft tissue adhesions
The 'Myofascial Adhesions in Patients after Breast Cancer (MAP-BC)'-tool will be used to assess the severity of soft tissue adhesions at the upper limb region (0-63) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Measured: Time frame up to 6 months post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start26 Apr 2022
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, An De Groef, KU Leuven
- Investigators
- An De Groef, Prof. Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297591
- Sponsor's protocol ID
- s66248
- Acronym
- UPLIFT-BC
- Status last verified
- Apr 2024
- First submitted
- 17 Mar 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24816774Berry 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.
PubMed 16251534De 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.
PubMed 28319882Lee 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.
PubMed 22818936Ustun 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.
PubMed 12959329Yang 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.
PubMed 22493627De 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.
PubMed 38754876
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT05297591
- Acronym / sponsor ID
- UPLIFT-BC / s66248
- Conditions
- Breast Cancer
- Keywords
- upper limb dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Vrije Universiteit Brussel
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| breast cancer patients | – | Other: assessment of UL function and prognostic factorsWomen and men diagnosed with breast cancer waiting for surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort will be selected from the population of breast cancer patients at the University Hospital Leuven
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of UL function and prognostic factorsclinical assessments and questionnaires | Other | breast cancer patients |
Primary outcome
Subjective upper limb function
Time frame: Time frame up to 6 months post-radiotherapy
quickDASH (0-100) questionnaire: An abbreviated version of the original DASH (Disabilities of the Arm, Shoulder and Hand) outcome measure. The questionnaire contains 11 items that measures an individual's ability to complete tasks, absorb forces and severity of symptoms, with a 5-point Linkert scale. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Objective upper limb function
Time frame: Time frame up to 6 months post-radiotherapy
Accelerometry: duration of upper limb use (hours) during one week. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of presence of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities
Time frame: Time frame up to 6 months post-radiotherapy
Basic inspection of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of pain intensity
Time frame: Time frame up to 6 months post-radiotherapy
Numeric Rating Scale (0-10) of pain intensity during movement during the week before assessment. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of presence of neuropathic pain
Time frame: Time frame up to 6 months post-radiotherapy
Presence of neuropathic pain (yes/no): Douleur Neuropathique en 4 questions (DN4) is a questionnaire generated for identifying pain of predominantly neuropathic origin. The DN4 consists of 7 self-reporting questions and 3 clinical examinations. A scoring of ≥4/10 is considered as a positive result for neuropathic pain. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of presence of sensory loss
Time frame: Time frame up to 6 months post-radiotherapy
Presence of sensory loss (yes/no) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of presence of widespread pain
Time frame: Time frame up to 6 months post-radiotherapy
Presence of widespread pain (yes/no) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of impact of pain on functioning
Time frame: Time frame up to 6 months post-radiotherapy
Brief Pain Inventory: the short version assesses the the impact of the pain on functioning.The Brief Pain Inventory is a valid multimodal scale for assessing pain in breast cancer patients. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Soft tissue stiffness index
Time frame: Time frame up to 6 months post-radiotherapy
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. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Total relative arm volume (%)
Time frame: Time frame up to 6 months post-radiotherapy
Relative arm volume: Bilateral circumferential measurements using a perimeter will be performed. Water displacement method hand: Bilateral water displacement method using a volumeter filled with water and allowed to settle at room temperature will be performed. Afterwards the total volume (mL) can be calculated by taking the sum of the two measurements. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of movement functions during a functional task
Time frame: Time frame up to 6 months post-radiotherapy
The 3D scapulothoracic and glenohumeral movements will be assessed using inertial sensors (MTw motion capture, Xsens Technologies, The Netherlands) at the endpoint (i.e. point of task achievement) of the performance of a functional task, the Upper Limb Function Test (ULIFT), which is a valid and reliable test to assess upper limb functionality in breast cancer patients. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Upper limb muscle strength (kg)
Time frame: Time frame up to 6 months post-radiotherapy
A hand-held dynamometer will be used to assess handgrip strength Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Pain catastrophizing
Time frame: Time frame up to 6 months post-radiotherapy
Pain Catastrophizing Scale (0-52) : It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Self-efficacy
Time frame: Time frame up to 6 months post-radiotherapy
General Self-Efficacy Scale:This scale is a self-report measure of self-efficacy with 10 items (scored from 1-4). The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Depression, Anxiety and Stress
Time frame: Time frame up to 6 months post-radiotherapy
Depression, Anxiety and Stress Scale (DASS-21) (range 0-132). The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Fear of movement
Time frame: Time frame up to 6 months post-radiotherapy
Adjusted 11-item Tampa Scale of Kinesiophobia. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Thus, total scores range from 11-44 points with higher scores indicating greater fear of pain, movement, and injury Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Body-perception
Time frame: Time frame up to 6 months post-radiotherapy
A self-developed Dutch version of the Fremantle Shoulder Awareness Questionnaire will be used. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of Quality of Life
Time frame: Time frame up to 6 months post-radiotherapy
European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). The QLQ-C30 is a validated questionnaire that incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of (Sub)optimal physical therapy care
Time frame: Time frame up to 6 months post-radiotherapy
Through a self-developed questionnaire, patients will be questioned whether they received no/suboptimal/optimal physical therapy care Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of treatment with Chemotherapy
Time frame: Time frame up to 6 months post-radiotherapy
no/taxanes/non-taxanes and neo-adjuvant/adjuvant (derived from the medical file) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of treatment with Hormone therapy
Time frame: Time frame up to 6 months post-radiotherapy
no/aromatase inhibitor/no-aromatase inhibitor (derived from the medical file) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Prognostic value of soft tissue adhesions
Time frame: Time frame up to 6 months post-radiotherapy
The 'Myofascial Adhesions in Patients after Breast Cancer (MAP-BC)'-tool will be used to assess the severity of soft tissue adhesions at the upper limb region (0-63) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 24816774Hidding 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.
- Background: PubMed 16251534Berry 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.
- Background: PubMed 28319882De 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.
- Background: PubMed 22818936Lee 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.
- Background: PubMed 12959329Ustun 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.
- Background: PubMed 22493627Yang 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.
- Derived from this study: PubMed 38754876De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nieke Vets contact
An De Groef, Prof. Dr. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact An De Groef, Prof. Dr. (003216376668, an.degroef@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective upper limb function (time frame: Time frame up to 6 months post-radiotherapy). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05297591, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.