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

Primary Purpose

Breast Cancer Lymphedema

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lymphedema prevention protocols
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Xi 'an

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

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

The control group received normal perioperative and chemotherapy nursing measures

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Changes in grip strength at baseline,9 weeks after surgery,and 18 weeks after surgery
The grip strength of the affected side was measured with the help of electronic grip strength meter. Test method: The patient stands straight with the arm down and the affected hand grasps the grip strength meter with force. Two measurements were taken and the average was taken. Change(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
The range of motion (ROM) of the upper limb of breast cancer patients was measured with a circular goniometer (0°-360°) . The rehabilitation technician measured the upper limb mobility in six directions: forward flexion, back extension, abduction, adduction, internal rotation, and external rotation. Change(Baseline-9 weeks after surgery-18 weeks after surgery)
Change in Arm disability at baseline,9 weeks after surgery,and 18 weeks after surgery
The Chinese version of the DASH scale, adapted from the DASH scale developed by Beaton, was used to assess the upper limb condition of the patients. Cronbach's A coefficient was 0. 911, and the intra-group correlation coefficient was 0. 882, which had good reliability and validity. The highest score is 100 and the lowest is 0, with higher scores indicating more severe upper arm problems. Change(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
Quality of life was evaluated using Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer, which was developed by Cella. It was translated into Chinese by Wan and the Cronbach 'α for each sub-scale was 0.61-0.84.The questionnaire had 36 items classified into five dimensions and all the items were measured with a 5-point Likert scale, The highest score is 144 and the lowest is 0,with higher scores indicating higher levels of quality of life. Change(Baseline-9 weeks after surgery-18 weeks after surgery)

Full Information

First Posted
September 23, 2022
Last Updated
October 24, 2022
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05595330
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Lymphedema

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Patients in the intervention group were managed with an upper extremity lymphedema prevention program.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group received normal perioperative and chemotherapy nursing measures
Intervention Type
Behavioral
Intervention Name(s)
Lymphedema prevention protocols
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in breast cancer-related lymphedema at baseline,9 weeks after surgery,and 18 weeks after surgery
Description
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)
Time Frame
Baseline-9 weeks after surgery-18 weeks after surgery
Secondary Outcome Measure Information:
Title
Changes in grip strength at baseline,9 weeks after surgery,and 18 weeks after surgery
Description
The grip strength of the affected side was measured with the help of electronic grip strength meter. Test method: The patient stands straight with the arm down and the affected hand grasps the grip strength meter with force. Two measurements were taken and the average was taken. Change(Baseline-9 weeks after surgery-18 weeks after surgery)
Time Frame
Baseline-9 weeks after surgery-18 weeks after surgery
Title
Changes in Shoulder range of motion at baseline,9 weeks after surgery,and 18 weeks after surgery
Description
The range of motion (ROM) of the upper limb of breast cancer patients was measured with a circular goniometer (0°-360°) . The rehabilitation technician measured the upper limb mobility in six directions: forward flexion, back extension, abduction, adduction, internal rotation, and external rotation. Change(Baseline-9 weeks after surgery-18 weeks after surgery)
Time Frame
Baseline-9 weeks after surgery-18 weeks after surgery
Title
Change in Arm disability at baseline,9 weeks after surgery,and 18 weeks after surgery
Description
The Chinese version of the DASH scale, adapted from the DASH scale developed by Beaton, was used to assess the upper limb condition of the patients. Cronbach's A coefficient was 0. 911, and the intra-group correlation coefficient was 0. 882, which had good reliability and validity. The highest score is 100 and the lowest is 0, with higher scores indicating more severe upper arm problems. Change(Baseline-9 weeks after surgery-18 weeks after surgery)
Time Frame
Baseline-9 weeks after surgery-18 weeks after surgery
Title
Change in Quality of life at baseline,9 weeks after surgery,and 18 weeks after surgery
Description
Quality of life was evaluated using Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer, which was developed by Cella. It was translated into Chinese by Wan and the Cronbach 'α for each sub-scale was 0.61-0.84.The questionnaire had 36 items classified into five dimensions and all the items were measured with a 5-point Likert scale, The highest score is 144 and the lowest is 0,with higher scores indicating higher levels of quality of life. Change(Baseline-9 weeks after surgery-18 weeks after surgery)
Time Frame
Baseline-9 weeks after surgery-18 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Xi 'an
City
XI 'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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