Clinical trial NCT05595330: Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients
Official title: Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Lymphedema
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: According to the inclusion and exclusion criteria, a total of 108 patients were enrolled and randomly divided into control group (n = 56) and intervention group (n = 52). The control group received routine nursing, while the intervention group received upper limb lymphedema prevention program for breast cancer patients after surgery. Before surgery, at the third chemotherapy (about 2.1 months after surgery) and the sixth chemotherapy (about 4.2 months after surgery), the self-designed general information questionnaire was used to investigate the patient's basic situation, and the corresponding tools were used to measure the volume of the patient's upper arm, the grip strength of the affected arm, and the range of motion of the affected shoulder joint.


Eligibility criteria: Inclusion Criteria:

* Female patients were≥18 years old
* Pathological puncture confirmed breast cancer with unilateral, no recurrence, and no metastasis
* Patients with clinical TNM stageⅠ\~Ⅲ
* Patients with proposed surgery and 6 or more chemotherapy
* The patient was conscious and aware of his condition, with no cognitive impairment or communication problems

Exclusion Criteria:

* Patients who had cancer other than breast cancer
* Patients who had history of arm or neck trauma, infection or surgery
* Patients who had serious diseases such as cardiovascular, cerebrovascular, liver, kidney, etc
* Patients who had upper limb disability or the affected limb has edema before surgery
* Patients who had thrombus in the blood vessels of the affected limb

Primary outcomes:
measure: Changes in breast cancer-related lymphedema at baseline,9 weeks after surgery,and 18 weeks after surgery
timeFrame: Baseline-9 weeks after surgery-18 weeks after surgery
Secondary outcomes:
measure: Changes in grip strength at baseline,9 weeks after surgery,and 18 weeks after surgery
timeFrame: Baseline-9 weeks after surgery-18 weeks after surgery
measure: Changes in Shoulder range of motion at baseline,9 weeks after surgery,and 18 weeks after surgery
timeFrame: Baseline-9 weeks after surgery-18 weeks after surgery
measure: Change in Arm disability at baseline,9 weeks after surgery,and 18 weeks after surgery
timeFrame: Baseline-9 weeks after surgery-18 weeks after surgery
measure: Change in Quality of life at baseline,9 weeks after surgery,and 18 weeks after surgery
timeFrame: Baseline-9 weeks after surgery-18 weeks after surgery
Other outcomes:
Locations:
city: XI 'an
country: China
facility: Xi 'an
state: Shaanxi
Study officials:
References: