Breast Cancer (Locally Advanced or Metastatic)(BCRL)NCT07803549
The Effect of Self-Management Interventions Among Patients With Breast Cancer Related-Lymphedema
A study testing Self-management Interventions in people with Breast Cancer (Locally Advanced or Metastatic) and Lymphedema Arm, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
Trial summary
To manage lymphedema, it's important to be aware of symptoms and risk factors, evaluate the afflicted extremity, prevent infections, care for the skin, protect the extremity from trauma, maintain a healthy weight, and exercise regularly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic), Lymphedema Arm
- What is being tested?
- Self-management Interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 28 Jan 2025to 20 Aug 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with BCRL are undergoing Mastectomy
- Adult patients ≥ 18 years old
- Women with breast cancer who could read and write
- Those who had been diagnosed with lymphedema.
Who cannot join
- Any patients with cognitive disability
- Patients diagnosed with metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Self-Management Interventions on Symptoms Severity and Quality of Life Among Patients With Breast Cancer Related-Lymphedema
To manage lymphedema, it's important to be aware of symptoms and risk factors, evaluate the afflicted extremity, prevent infections, care for the skin, protect the extremity from trauma, maintain a healthy weight, and exercise regularly. Patients were informed face-face about the development and risk factors of lymphedema before and after surgery (first and second day). Educational themes: Symptoms and signs of lymphedema, Development mechanisms and risk factors of lymphedema, Evaluation of lymphedema, Prevention of possible infections, Skin care, Protecting the arm and the breast from traumas, having ideal weight, Exercising.
Read the detailed description
The implemented protocol (self-management interventions) includes several parts. First part was informing in which patients were informed face-face about the development and risk factors of lymphedema before and after surgery (first and second day). Educational themes: symptoms and signs of lymphedema, development mechanisms and risk factors of lymphedema, evaluation of lymphedema, prevention of possible infections, skin care, protecting the arm and the breast from traumas, having ideal weight, and exercising. Second part include lymphedema evaluation, in which measuring for the upper extremity circumference was done in the hospital using the metric measuring tape. The measurement was taken at four locations; specifically, metacarpophalangeal joints, at the wrist, 10 cm above and below the elbow joint. Third part was exercising program in which the patients during the first 24 hours after surgery were instructed to perform hand squeezing exercises with a medium-level stress ball four times a day, squeezing 15 times each. The researcher estimated the appropriate amount of exercise and start time for the patient based on their physical state and general health all over the post-operative period. Patients were instructed to perform active and passive arm exercises three to six times per day at start, gradually increasing to ten, shifting from passive to active within 30-60 minutes. Patients were instructed to warm up before exercising to prevent muscular damage and divide activities into 10-15-minutes sessions in case of pain. Fourth part was about simple lymphatic drainage where during patient massage, the researcher showed and taught deep diaphragmatic breathing exercises, neck drainage, afflicted side axillary drainage, and upper extremity drainage. Before the massage began, the patients practiced breathing exercises. To activate the lymphatic system, breathing exercises were initially done 3 times a day for 3 minutes, then increased to 3 times a day for 5 minutes in the months following.
- Being tested
- Self-management Interventions
- Keywords
- Self-Management Interventions
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management InterventionsBehavioural
During the first 24 hours after surgery, patients were instructed to perform hand squeezing exercises with a medium-level stress ball four times a day, squeezing 15 times each. Patients were instructed to perform active and passive arm exercises three to six times per day at start, gradually increasing to ten, shifting from passive to active within 30-60 minutes. Patients were instructed to warm up before exercising to prevent muscular damage and divide activities into 10-15 minute sessions in case of pain.
Simple lymphatic drainage:
During patient massage, the researcher showed and taught deep diaphragmatic breathing exercises, neck drainage, afflicted side axillary drainage, and upper extremity drainage. Before the massage began, the patients practiced breathing exercises. To activate the lymphatic system, breathing exercises were initially done 3 times a day for 3 minutes, then increased to 3 times a day for 5 minutes in the months following.
| Study group | Role | What they receive |
|---|---|---|
| self-management interventions | Experimental | For patients assigned for intervention group (self-management interventions), they received education on self-management intervention and exercise training. The follow-up data collection performed at first month later in clinic, when the researcher returned to the same patient and evaluated the changes by takes upper extremity circumference measurement, LISD scale, and QOL questionnaires. Using self-administered technique, it is possible to assess any changes in the patient's risk of developing lymphedema over time. Then follow up at third month takes by telephone. For the Placebo group data were collected at baseline, follow-up one month, and 3-months without implementing the program. Receives: Behavioral: Self-management Interventions |
| Control group (placebo) | No intervention | For the placebo group data were collected at baseline, follow-up one month, and 3-months without implementing the program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Lymphedema Symptom and Intensity Distress-Arm (LSID-A) tool is reliable to assess symptoms and distress related to lymphedema in the upper extremities, especially for breast cancer survivors. LSID-A measure the percentage of patients with lymphedema
The Lymphedema Symptom and Intensity Distress-Arm (LSID-A) Questionnaire is a reliable tool for assessing symptoms and distress related to lymphedema in the upper extremities, especially for breast cancer survivors. It consists of 30 items grouped into seven symptom clusters: Soft Tissue Sensation (4 items), Neurologic Sensation (7 items), Function (2 items), Biobehavioral (9 items), Resource (2 items), Sexuality (3 items), and Activity (3 items). Each item evaluates symptom presence with a "Yes" or "No," intensity on a 5-point scale from 0 (not present) to 5 (extremely intense), and distress on a similar scale from 0 (not distressing) to 5 (extremely distressing). The total score ranges from 0 to 30, with higher scores indicating greater severity and distress.
Measured: From enrollment to the end of treatment at 12 weeks (3 months)
The Lymphedema Quality of Life Questionnaire (LYMQOL) is valid instrument to evaluate the impact of lymphedema on various aspects of life, emphasizing physical, emotional, and social dimensions. LYMQOL assess the level of QoL for patient with lymphedema
The Lymphedema Quality of Life Questionnaire (LYMQOL) is a valid and reliable instrument designed to evaluate the impact of lymphedema on various aspects of life, emphasizing physical, emotional, and social dimensions. The questionnaire comprises 27 items organized into four domains: 1. Function domain (items 1a - 1h, 2, 3) that assesses mobility, daily activities, and pain levels; 2. Appearance and Body Image domain (items 4-8) that explores concerns related to anxiety, depression, and body image; 3. Symptoms (items 9-14) that examines physical manifestations such as swelling, heaviness, and discomfort; 4. Emotion domain (items 15-20) that reflects feelings of social exclusion and emotional distress. Overall quality of life (Q21) is rated on a scale from 0 to 10. Participants respond using a Likert scale ranging from 1 to 4. A total score for each domain was calculated by adding all scores together and dividing by the total number of questions answered. Higher scores mean poor QoL.
Measured: From enrollment to the end of treatment at 12 weeks (3 months)
Secondary outcomes (1)
Upper Extremities Circumference was used to examine the presence of lymphedema before and after the self-management intervention, using the metric measuring tape. Upper Extremities Circumference measuring the distance around the midpoint of the arm.
The upper extremities were measured to examine the presence of lymphedema before and after the self-management intervention, using the metric measuring tape. The measurement was taken at four locations; specifically, metacarpophalangeal joints, at the wrist, 10 cm above and below the elbow joint.
Measured: From enrollment to the end of treatment at 12 weeks (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start28 Jan 2025
- Primary completion30 Jul 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Minwer Alnaeem, Al-Zaytoonah University of Jordan
- Investigators
- Anoud J. Alsouliman, MsN, Principal investigator, Al-Zaytoonah University of Jordan Faculty of NursingMohammad M Alnaeem, Ph.D., Principal investigator, Al-Zaytoonah University of Jordan Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803549
- Sponsor's protocol ID
- MOH/REC/2024/41
- Other IDs
- 2025-2024/174/03
- Acronym
- (BCRL)
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Natarajan MK 4th, S J N, Mohanraj J, Vishwanath U. The Effect of Education on Knowledge Regarding Breast Cancer Related Lymphedema Risk Reduction and Prevention Among Nursing Personnel. Cureus. 2023 Sep 15;15(9):e45331. doi: 10.7759/cureus.45331. eCollection 2023 Sep.
PubMed 37849580Cansiz G, Arikan Donmez A, Kapucu S, Borman P. The effect of a self-management lymphedema education program on lymphedema, lymphedema-related symptoms, patient compliance, daily living activities and patient activation in patients with breast cancer-related lymphedema: A quasi-experimental study. Eur J Oncol Nurs. 2022 Feb;56:102081. doi: 10.1016/j.ejon.2021.102081. Epub 2021 Dec 1.
PubMed 34875398Demir, S.G., 2008. Self-management of lymphedema in patients undergoing surgery for breast cancer. Journal of Breast Health 4 (2), 62-69.
Huang TW, Tseng SH, Lin CC, Bai CH, Chen CS, Hung CS, Wu CH, Tam KW. Effects of manual lymphatic drainage on breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. World J Surg Oncol. 2013 Jan 24;11:15. doi: 10.1186/1477-7819-11-15.
PubMed 23347817Imokhai, P. O., Hall, O., Cardone, T. A., Vinagolu-Baur, J., Tilghman, H., Dunmore, K., & Brooks, A. Novel Approach to Early Diagnosis and Management of Lymphedema Following Axillary Lymph Node Dissection in Breast Cancer Surgery. http://dx.doi.org/10.20431/2455-572X.1101003
Lian Y, Sandhu S, Asefa Y, Gupta A. The Effect of Exercise on Reducing Lymphedema Severity in Breast Cancer Survivors. Cancers (Basel). 2024 Mar 30;16(7):1367. doi: 10.3390/cancers16071367.
PubMed 38611045Liu F, Li F, Fu MR, Zhao Q, Wang Y, Pang D, Yang P, Jin S, Lu Q. Self-management Strategies for Risk Reduction of Subclinical and Mild Stage of Breast Cancer-Related Lymphedema: A Longitudinal, Quasi-experimental Study. Cancer Nurs. 2021 Nov-Dec 01;44(6):E493-E502. doi: 10.1097/NCC.0000000000000919.
PubMed 34694088Omidi Z, Kheirkhah M, Abolghasemi J, Haghighat S. Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial. Qual Life Res. 2020 Jul;29(7):1789-1800. doi: 10.1007/s11136-020-02455-z. Epub 2020 Mar 9.
PubMed 32152817
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Management Interventions on Symptoms Severity and Quality of Life Among Patients With Breast Cancer Related-Lymphedema
- ClinicalTrials.gov ID
- NCT07803549
- Acronym / sponsor ID
- (BCRL) / MOH/REC/2024/41
- Keywords
- Self-Management Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 3 Sep 2026 (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.
To manage lymphedema, it's important to be aware of symptoms and risk factors, evaluate the afflicted extremity, prevent infections, care for the skin, protect the extremity from trauma, maintain a healthy weight, and exercise regularly. Patients were informed face-face about the development and risk factors of lymphedema before and after surgery (first and second day). Educational themes: Symptoms and signs of lymphedema, Development mechanisms and risk factors of lymphedema, Evaluation of lymphedema, Prevention of possible infections, Skin care, Protecting the arm and the breast from traumas, having ideal weight, Exercising.
Detailed description
The implemented protocol (self-management interventions) includes several parts. First part was informing in which patients were informed face-face about the development and risk factors of lymphedema before and after surgery (first and second day). Educational themes: symptoms and signs of lymphedema, development mechanisms and risk factors of lymphedema, evaluation of lymphedema, prevention of possible infections, skin care, protecting the arm and the breast from traumas, having ideal weight, and exercising. Second part include lymphedema evaluation, in which measuring for the upper extremity circumference was done in the hospital using the metric measuring tape. The measurement was taken at four locations; specifically, metacarpophalangeal joints, at the wrist, 10 cm above and below the elbow joint. Third part was exercising program in which the patients during the first 24 hours after surgery were instructed to perform hand squeezing exercises with a medium-level stress ball four times a day, squeezing 15 times each. The researcher estimated the appropriate amount of exercise and start time for the patient based on their physical state and general health all over the post-operative period. Patients were instructed to perform active and passive arm exercises three to six times per day at start, gradually increasing to ten, shifting from passive to active within 30-60 minutes. Patients were instructed to warm up before exercising to prevent muscular damage and divide activities into 10-15-minutes sessions in case of pain. Fourth part was about simple lymphatic drainage where during patient massage, the researcher showed and taught deep diaphragmatic breathing exercises, neck drainage, afflicted side axillary drainage, and upper extremity drainage. Before the massage began, the patients practiced breathing exercises. To activate the lymphatic system, breathing exercises were initially done 3 times a day for 3 minutes, then increased to 3 times a day for 5 minutes in the months following.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-management interventions | Experimental | Behavioral: Self-management InterventionsFor patients assigned for intervention group (self-management interventions), they received education on self-management intervention and exercise training. The follow-up data collection performed at first month later in clinic, when the researcher returned to the same patient and evaluated the changes by takes upper extremity circumference measurement, LISD scale, and QOL questionnaires. Using self-administered technique, it is possible to assess any changes in the patient's risk of developing lymphedema over time. Then follow up at third month takes by telephone. For the Placebo group data were collected at baseline, follow-up one month, and 3-months without implementing the program. |
| Control group (placebo) | No intervention | –For the placebo group data were collected at baseline, follow-up one month, and 3-months without implementing the program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with BCRL are undergoing Mastectomy
- Adult patients ≥ 18 years old
- Women with breast cancer who could read and write
- Those who had been diagnosed with lymphedema.
Key exclusion criteria (2 listed)
- Any patients with cognitive disability
- Patients diagnosed with metastasis
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 |
|---|---|---|
| Self-management InterventionsDuring the first 24 hours after surgery, patients were instructed to perform hand squeezing exercises with a medium-level stress ball four times a day, squeezing 15 times each. Patients were instructed to perform active and passive arm exercises three to six times per day at start, gradually increasing to ten, shifting from passive to active within 30-60 minutes. Patients were instructed to warm up before exercising to prevent muscular damage and divide activities into 10-15 minute sessions in case of pain. Simple lymphatic drainage: During patient massage, the researcher showed and taught deep diaphragmatic breathing exercises, neck drainage, afflicted side axillary drainage, and upper extremity drainage. Before the massage began, the patients practiced breathing exercises. To activate the lymphatic system, breathing exercises were initially done 3 times a day for 3 minutes, then increased to 3 times a day for 5 minutes in the months following. | Behavioural | self-management interventions |
Primary outcome
The Lymphedema Symptom and Intensity Distress-Arm (LSID-A) tool is reliable to assess symptoms and distress related to lymphedema in the upper extremities, especially for breast cancer survivors. LSID-A measure the percentage of patients with lymphedema
Time frame: From enrollment to the end of treatment at 12 weeks (3 months)
The Lymphedema Symptom and Intensity Distress-Arm (LSID-A) Questionnaire is a reliable tool for assessing symptoms and distress related to lymphedema in the upper extremities, especially for breast cancer survivors. It consists of 30 items grouped into seven symptom clusters: Soft Tissue Sensation (4 items), Neurologic Sensation (7 items), Function (2 items), Biobehavioral (9 items), Resource (2 items), Sexuality (3 items), and Activity (3 items). Each item evaluates symptom presence with a "Yes" or "No," intensity on a 5-point scale from 0 (not present) to 5 (extremely intense), and distress on a similar scale from 0 (not distressing) to 5 (extremely distressing). The total score ranges from 0 to 30, with higher scores indicating greater severity and distress.
The Lymphedema Quality of Life Questionnaire (LYMQOL) is valid instrument to evaluate the impact of lymphedema on various aspects of life, emphasizing physical, emotional, and social dimensions. LYMQOL assess the level of QoL for patient with lymphedema
Time frame: From enrollment to the end of treatment at 12 weeks (3 months)
The Lymphedema Quality of Life Questionnaire (LYMQOL) is a valid and reliable instrument designed to evaluate the impact of lymphedema on various aspects of life, emphasizing physical, emotional, and social dimensions. The questionnaire comprises 27 items organized into four domains: 1. Function domain (items 1a - 1h, 2, 3) that assesses mobility, daily activities, and pain levels; 2. Appearance and Body Image domain (items 4-8) that explores concerns related to anxiety, depression, and body image; 3. Symptoms (items 9-14) that examines physical manifestations such as swelling, heaviness, and discomfort; 4. Emotion domain (items 15-20) that reflects feelings of social exclusion and emotional distress. Overall quality of life (Q21) is rated on a scale from 0 to 10. Participants respond using a Likert scale ranging from 1 to 4. A total score for each domain was calculated by adding all scores together and dividing by the total number of questions answered. Higher scores mean poor QoL.
1 secondary outcome
Upper Extremities Circumference was used to examine the presence of lymphedema before and after the self-management intervention, using the metric measuring tape. Upper Extremities Circumference measuring the distance around the midpoint of the arm.
Time frame: From enrollment to the end of treatment at 12 weeks (3 months)
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 3 Sep 2026.
- Results publication: PubMed 37849580Natarajan MK 4th, S J N, Mohanraj J, Vishwanath U. The Effect of Education on Knowledge Regarding Breast Cancer Related Lymphedema Risk Reduction and Prevention Among Nursing Personnel. Cureus. 2023 Sep 15;15(9):e45331. doi: 10.7759/cureus.45331. eCollection 2023 Sep.
- Results publication: PubMed 34875398Cansiz G, Arikan Donmez A, Kapucu S, Borman P. The effect of a self-management lymphedema education program on lymphedema, lymphedema-related symptoms, patient compliance, daily living activities and patient activation in patients with breast cancer-related lymphedema: A quasi-experimental study. Eur J Oncol Nurs. 2022 Feb;56:102081. doi: 10.1016/j.ejon.2021.102081. Epub 2021 Dec 1.
- Results publicationDemir, S.G., 2008. Self-management of lymphedema in patients undergoing surgery for breast cancer. Journal of Breast Health 4 (2), 62-69.
- Results publication: PubMed 23347817Huang TW, Tseng SH, Lin CC, Bai CH, Chen CS, Hung CS, Wu CH, Tam KW. Effects of manual lymphatic drainage on breast cancer-related lymphedema: a systematic review and meta-analysis of randomized controlled trials. World J Surg Oncol. 2013 Jan 24;11:15. doi: 10.1186/1477-7819-11-15.
- Results publicationImokhai, P. O., Hall, O., Cardone, T. A., Vinagolu-Baur, J., Tilghman, H., Dunmore, K., & Brooks, A. Novel Approach to Early Diagnosis and Management of Lymphedema Following Axillary Lymph Node Dissection in Breast Cancer Surgery. http://dx.doi.org/10.20431/2455-572X.1101003
- Results publication: PubMed 38611045Lian Y, Sandhu S, Asefa Y, Gupta A. The Effect of Exercise on Reducing Lymphedema Severity in Breast Cancer Survivors. Cancers (Basel). 2024 Mar 30;16(7):1367. doi: 10.3390/cancers16071367.
- Results publication: PubMed 34694088Liu F, Li F, Fu MR, Zhao Q, Wang Y, Pang D, Yang P, Jin S, Lu Q. Self-management Strategies for Risk Reduction of Subclinical and Mild Stage of Breast Cancer-Related Lymphedema: A Longitudinal, Quasi-experimental Study. Cancer Nurs. 2021 Nov-Dec 01;44(6):E493-E502. doi: 10.1097/NCC.0000000000000919.
- Results publication: PubMed 32152817Omidi Z, Kheirkhah M, Abolghasemi J, Haghighat S. Effect of lymphedema self-management group-based education compared with social network-based education on quality of life and fear of cancer recurrence in women with breast cancer: a randomized controlled clinical trial. Qual Life Res. 2020 Jul;29(7):1789-1800. doi: 10.1007/s11136-020-02455-z. Epub 2020 Mar 9.
- Individual participant dataSharing planned: Yes
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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.
Anoud J. Alsouliman, MsN principal investigator
Al-Zaytoonah University of Jordan Faculty of Nursing
Mohammad M Alnaeem, Ph.D. principal investigator
Al-Zaytoonah University of Jordan Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management Interventions in people with Breast Cancer (Locally Advanced or Metastatic) and Lymphedema Arm, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
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 4 inclusion and 2 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 3 Sep 2026. 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 Jordan. 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?
The Lymphedema Symptom and Intensity Distress-Arm (LSID-A) tool is reliable to assess symptoms and distress related to lymphedema in the upper extremities, especially for breast cancer survivors. LSID-A measure the percentage of patients with lymphedema (time frame: From enrollment to the end of treatment at 12 weeks (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07803549, which also lists 8 linked publications.
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 3 Sep 2026.