Breast Cancer LymphedemaNCT05595330
Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients
A study testing Lymphedema prevention protocols in people with Breast Cancer Lymphedema, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Lymphedema
- What is being tested?
- Lymphedema prevention protocols
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 8 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients: a Randomized Clinical Trial
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
- Being tested
- Lymphedema prevention protocols
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphedema prevention protocolsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Patients in the intervention group were managed with an upper extremity lymphedema prevention program. Receives: Behavioral: Lymphedema prevention protocols |
| control group | No intervention | The control group received normal perioperative and chemotherapy nursing measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline-9 weeks after surgery-18 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Mar 2020
- Primary completion27 Nov 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer LymphedemaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Bohui, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595330
- Sponsor's protocol ID
- 19900601
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lymphedema Prevention Program Based on Theory of Knowledge-attitude-practice on Postoperative Breast Cancer Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05595330
- Acronym / sponsor ID
- 19900601
- Conditions
- Breast Cancer Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 27 Nov 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Lymphedema prevention protocolsPatients in the intervention group were managed with an upper extremity lymphedema prevention program. |
| control group | No intervention | –The control group received normal perioperative and chemotherapy nursing measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphedema prevention protocolsComing 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. | Behavioural | intervention group |
Primary outcome
Changes in breast cancer-related lymphedema at baseline,9 weeks after surgery,and 18 weeks after surgery
Time frame: Baseline-9 weeks after surgery-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)
4 secondary outcomes
Changes in grip strength at baseline,9 weeks after surgery,and 18 weeks after surgery
Time frame: 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
Time frame: Baseline-9 weeks after surgery-18 weeks after surgery
Change in Arm disability at baseline,9 weeks after surgery,and 18 weeks after surgery
Time frame: 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
Time frame: Baseline-9 weeks after surgery-18 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphedema prevention protocols in people with Breast Cancer Lymphedema, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in breast cancer-related lymphedema at baseline,9 weeks after surgery,and 18 weeks after surgery (time frame: Baseline-9 weeks after surgery-18 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.