Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments

Breast Cancer Clinical Trial

Official title:

Development of a Screening Tool for Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950685
• Other study ID #: 0019-22ASMC
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: Assuta Medical Center
• Contact: Ifat klein, B.PT
• Phone: 0506764695
• Email: ifatgoldberg[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Israel	Assuta medical center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Ifat Klein	Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QuickDASH questionnaire	a shortened version of the The Disabilities of the Arm, Shoulder and Hand (DASH), that contains 11 items measuring an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to her severity/function level. The the scores range from 0 (no disability) to 100 (most severe disability).	18 months
Primary	Numeric pain rating scale	Pain scale reported by patients with rage of 0(no pain)-10(the worst possible pain imaginable).	18 months
Primary	The Godin-Shephard Leisure-Time Physical Activity	divides the effort levels into light/ mild, moderate, strenuous and multiply by time per week.	18 months
Secondary	Number of patients diagnosed with lymphedema	Diagnosis of lymphedema by a doctor / physical therapist	18 months
Secondary	Shoulder range of motion	Using DR Goniometer App evaluating ranges of motion in degrees between 0 (no range) to 180 (full range)	18 months