Clinical trial NCT05950685: Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments
Official title: Development of a Screening Tool for Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2023-07-18
Enrollment: 1316
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patient six months till three years after surgery

Brief summary: Background: Breast cancer (BC) treatments usually include a combination of surgery, chemotherapy and radiation. These life-saving treatments cause high percentages of arm morbidity, which often lasts for months, or develops months after surgery. Arm and shoulder morbidity includes prolonged pain, restriction of movement, limitation of function and lymphedema (chronic progressive edema). All of these morbidities affect the quality of life (QOL) of the recovering patients and require lengthy care. Early detection of patients at risk and provision of proactive treatment can improve the recovery process from surgery and oncology treatments.

Aim: To develop a screening tool for the early identification of women at high risk for prolonged arm morbidity following BC treatments (persistent pain, lymphedema, function deficits and decreased range of motion), validate the tool, and examine the efficiency of intervention based on the the use of the tool.

Detailed description: The development and the assessment of the screening tool will conduct in three stages:

1. Systematic review and meta-analysis to identify from the literature risk factors for lymphedema, prolong pain, decreased range of motion (ROM), quality of life (QOL) and function after breast cancer (BC) treatments and surgery. Intended to understand which factor could be included in the screening tool.
2. Development of the screening tool (study no. 1)- cross section study that will examine which of the risk factors found in the literature review/ meta-analysis will enter the tool. Women up to 3 years after BC surgery will be evaluated for arm morbidity (pain, lymphedema, limitation of movement and limitation of function), and their association to the risk factors, using an online questionnaire.
3. A small cohort study (study no. 2)- Aimed to validate the screening tool. The study will be conducted at the hospital's oncology institute, and will recruit BC survivors who come for routine follow-up six months till three years after surgery. Patients will be asked to answer an online questionnaire, in addition, limb volume tests, strength and ROM will be performed at the clinic. A comparison will be made between the physical parameters that indicate the morbidity of the arm and the score found in the screening tool.
4. A small prospective study (study no. 3)- The main goal of this study is to examine whether the use of the new questionnaire by the patients themselves will; A) affect the percentage of arrival to physical therapy (PT) treatments, B) will affect morbidity rates.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-75
* Independent
* Speaking Hebrew and Russian

Exclusion Criteria:

* Patients who reported that from the time elapsed from the surgery they underwent additional surgery or an injury affecting the function/ pain of the arm.
* Patients suffering from advanced metastatic disease, or background diseases that limit function.
* Lymphedema prior to surgery.

Primary outcomes:
measure: QuickDASH questionnaire
timeFrame: 18 months
measure: Numeric pain rating scale
timeFrame: 18 months
measure: The Godin-Shephard Leisure-Time Physical Activity
timeFrame: 18 months
Secondary outcomes:
measure: Number of patients diagnosed with lymphedema
timeFrame: 18 months
measure: Shoulder range of motion
timeFrame: 18 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta medical center
Study officials:
affiliation: Assuta Medical Center
name: Merav Ben- David, Professor
role: PRINCIPAL_INVESTIGATOR
References: