Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients

NCT05595330 | Completed

• 1 other identifier: 19900601
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Lymphedema

Outcome Measures

Primary Outcomes (1)

• Changes in breast cancer-related lymphedema at baseline,9 weeks after surgery,and 18 weeks after surgery

  Use an inelastic, flexible soft ruler to measure the circumference at 5 positions on the flat wrist crease, 0cm, 10cm, 20cm, 30cm, and 40cm on the wrist crease. The upper limb can be divided into 4 truncated cones, and the measured value is accurate to 0.1 cm. The upper arm volume is calculated using the formula , each h is 10 cm, C1 and C2 are the circumferences next to the two measurement points, and then add up the limb volumes at several positions to get the upper arm volume. According to the International Society of Lymphoma, a volume difference of 10% or more is defined as lymphedema, less than 20% is mild lymphedema, 20% - 40% is moderate lymphedema, and greater than 40% is defined as severe lymphedema. Change(Baseline-9 weeks after surgery-18 weeks after surgery)

  Baseline-9 weeks after surgery-18 weeks after surgery

Secondary Outcomes (4)

• Changes in grip strength at baseline,9 weeks after surgery,and 18 weeks after surgery

  Baseline-9 weeks after surgery-18 weeks after surgery

• Changes in Shoulder range of motion at baseline,9 weeks after surgery,and 18 weeks after surgery

  Baseline-9 weeks after surgery-18 weeks after surgery

• Change in Arm disability at baseline,9 weeks after surgery,and 18 weeks after surgery

  Baseline-9 weeks after surgery-18 weeks after surgery

• Change in Quality of life at baseline,9 weeks after surgery,and 18 weeks after surgery

  Baseline-9 weeks after surgery-18 weeks after surgery

Study Arms (2)

intervention group

EXPERIMENTAL

Patients in the intervention group were managed with an upper extremity lymphedema prevention program.

Behavioral: Lymphedema prevention protocols

control group

NO INTERVENTION

The control group received normal perioperative and chemotherapy nursing measures

Interventions

Lymphedema prevention protocols BEHAVIORAL

Coming for surgery: A PPT lecture; 2. A seminar; 3. Patients were given a lymphedema prevention brochure; 4. Diary cards for exercise is given and instruct patients to fill out daily; 5. Establish a WeChat group. The first chemotherapy:1. Review diary card and provide guidance and education. 2. A PPT lecture; 3. A seminar; 4. Play functional exercise videos in the recovery room; 5. Rehabilitation volunteers come to the ward to form mutual help groups with patients under the guidance of subject team members; 6. Instruct regular exercise and avoid behaviors that can lead to lymphedema. 7. Ask about the exercise and whether there is any swelling and discomfort and give guidance. The second chemotherapy: 1. A PPT lecture; 2. A seminar; 3. Play functional exercise videos in the recovery room. The third chemotherapy: 1. Routine nursing; 2. Assess patients' knowledge of lymphedema prevention and exercise compliances; 3. Play functional exercise videos in the recovery room.

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

Xi 'an

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse in charge

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 26, 2022
• Study Start: March 1, 2020
• Primary Completion: November 27, 2020
• Study Completion: December 8, 2020
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)