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Trial Title:
Prediction of Long-term Arm Morbidity Following Breast Cancer Surgeries and Treatments
NCT ID:
NCT05950685
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Breast cancer patient six months till three years after surgery
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Gender based:
Yes
Gender description:
breast cancer patients
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Assuta medical center
Address:
City:
Tel Aviv
Zip:
6345415
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Ifat klein, BPT
Phone:
0506764695
Email:
ifatgoldberg@hotmail.com
Start date:
January 1, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Ifat Klein
Agency class:
Other
Collaborator:
Agency:
Ben-Gurion University of the Negev
Agency class:
Other
Source:
Assuta Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05950685
