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

NCT ID: NCT05595330

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-12-08

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Lymphedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

Lymphedema prevention protocols

Intervention Type 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.

control group

The control group received normal perioperative and chemotherapy nursing measures

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lymphedema prevention protocols

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 Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Shi Bohui

Nurse in charge

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xi 'an

Xi'an, Shaanxi, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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19900601

Identifier Type: -

Identifier Source: org_study_id

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