Breast Cancer Related LymphedemaNCT05058495
The Effect of Mobile Lymphedema Self-Care Support Program on Self-Care in Women With Breast Cancer-related Lymphedema
A study testing Mobile Lymphedema Self-Care Support Program and standart lymphedema education in people with Breast Cancer Related Lymphedema, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study is to evaluate the effect of the mobile lymphedema self-care support program on self-care, quality of life and symptoms related to lymphedema in women with breast cancer-related lymphedema. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women only
- Conditions the study is for
- Breast Cancer Related Lymphedema
- What is being tested?
- Mobile Lymphedema Self-Care Support Program and standart lymphedema education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 Dec 2021
- 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 20 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed as breast cancer-related lymphedema
- literate,
- having a smart phone,
- completed breast cancer treatment at least six months ago
- volunteering to participate in the study
Who cannot join
- having morbid obesity
- having metastazis
- having dementia
- having other psychiatric conditions
- another health problem that could prevent to exercise
- not using smart phone
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege Universitesi, Lymphedema unit of Physical therapy and rehabilitation department
Izmir, Bornova, 35030
About this study
Official title: Investigation of the Effect of Mobile Lymphedema Self-Care Support Program on Self-Care, Quality of Life and Lymphedema-Related Symptoms in Women With Breast Cancer-related Lymphedema: A Randomized Controlled Trial
The aim of this randomized controlled study is to evaluate the effect of the mobile lymphedema self-care support program on self-care, quality of life and symptoms related to lymphedema in women with breast cancer-related lymphedema.
H1: There is a difference between the Lymphedema Self-Care Scale mean score in women who develop lymphedema due to breast cancer, according to the use of the mobile lymphedema self-care support program.
Read more
H2: There is a difference between the Lymphedema Quality of Life Scale average score in women who develop lymphedema due to breast cancer according to the status of using the mobile lymphedema self-care support program.
H4: There is a difference between lymphedema arm circumference measurements according to the use of the mobile lymphedema self-care support program in women who develop lymphedema due to breast cancer.
H5: In women who develop lymphedema due to breast cancer, there is a difference in the situation of experiencing symptoms related to lymphedema according to the use of the mobile lymphedema self-care support program.
Read the detailed description
The content of the mobile program was developed by the researchers. The mobile lymphedema self-care support program content was reviewed by an expert group consisting of doctors, physiotherapists and nurses working with patients with lymphedema. Patients will be contacted via telephone and will be informed about the study, and the experimental and control groups will be selected through the randomization program among the patients who agree to participate in the study and meet the sampling inclusion criteria. Patients were blinded, and blindness will be achieved in the data analysing stage. All measurements will be made to the experimental and control groups at the same time. The standard lymphedema self-care training will be given to the experimental and the control group. And the experimental group will be educated on how to use the mobile program. When the study is completed, the control group will also be allowed to use the mobile program.
- Conditions
- Breast Cancer Related Lymphedema
- Being tested
- Mobile Lymphedema Self-Care Support Program, standart lymphedema education
- Keywords
- self-care, mobile application, quality of life, patient education, symptoms, Breast Cancer Related Lymphedema
- 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.
Mobile Lymphedema Self-Care Support ProgramOther
Also called standard lymphedema education
The Mobile Lymphedema Self-Care Support Program is composed of three section. First section includes the information about lymphedema and lymphedema self care. Second section includes the exercises videos which women can concurrently exercise with application and an alarm to remind to exercise. Last section is a social network form the women could chat and share anything with eachother. Patients will be told how to use the Mobile Lymphedema Self-Care Support Program and a contact number will be provided to ask questions about the program at any time.
standart lymphedema educationOther
The control group will receive standard lymphedema education. The standard lymphedema education is an online education composed of information about lymphedema and lymphedema self-care.
| Study group | Role | What they receive |
|---|---|---|
| mobile programme users | Experimental | Patients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education. Receives: Other: Mobile Lymphedema Self-Care Support Program; Other: standart lymphedema education |
| control group | Active comparator | Patients who will receive standart lymphedema education Receives: Other: standart lymphedema education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breast Cancer Related Lymphedema Self-Care Scale Score
The Breast Related Lymphedema Self-Care Scale is valid and reliable tool. The lowest score is 31, the highest score is 124. Higher scores indicate better self-care.
Measured: baseline, 1 month, 3 month
Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score
The Quality of Life Measure for Limb Lymphedema-Arm Scale was translated and cross-culturally adapted to Turkish. The highest score of the scale is 80 and the lowest score is 20. A high score indicates poor quality of life.
Measured: baseline, 1 month, 3 month
Change in Lymphedema Symptom Intensity and Distress Survey Score
The Turkish version of Lymphedema Symptom Intensity and Distress Survey is valid and reliable. The highest score of the scale is 30 and the lowest score is zero. A high score means experiencing too many symptoms.
Measured: baseline, 1 month, 3 month
Secondary outcomes (1)
Change in Arm circumferences
Circumferential measurements are taken at the metacarpal joint, wrist, elbow, 10 cm below and 10 cm above the elbow.
Measured: baseline, 1 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Related LymphedemaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective, randomized controlled study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Deveci, Dokuz Eylul University
- Investigators
- Özgül Karayurt, PhD, Study chair, Izmir University of EconomicsSibel Eyigör, MD, Study chair, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058495
- Sponsor's protocol ID
- 2020.KB.SAG.069
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2021
- Last updated
- 20 Feb 2024
- 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Mobile Lymphedema Self-Care Support Program on Self-Care, Quality of Life and Lymphedema-Related Symptoms in Women With Breast Cancer-related Lymphedema: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05058495
- Acronym / sponsor ID
- 2020.KB.SAG.069
- Conditions
- Breast Cancer Related Lymphedema
- Keywords
- self-care, mobile application, quality of life, patient education, symptoms, Breast Cancer Related Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 27 Sep 2021 (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.
The aim of this randomized controlled study is to evaluate the effect of the mobile lymphedema self-care support program on self-care, quality of life and symptoms related to lymphedema in women with breast cancer-related lymphedema.
H1: There is a difference between the Lymphedema Self-Care Scale mean score in women who develop lymphedema due to breast cancer, according to the use of the mobile lymphedema self-care support program.
H2: There is a difference between the Lymphedema Quality of Life Scale average score in women who develop lymphedema due to breast cancer according to the status of using the mobile lymphedema self-care support program.
H4: There is a difference between lymphedema arm circumference measurements according to the use of the mobile lymphedema self-care support program in women who develop lymphedema due to breast cancer.
H5: In women who develop lymphedema due to breast cancer, there is a difference in the situation of experiencing symptoms related to lymphedema according to the use of the mobile lymphedema self-care support program.
Detailed description
The content of the mobile program was developed by the researchers. The mobile lymphedema self-care support program content was reviewed by an expert group consisting of doctors, physiotherapists and nurses working with patients with lymphedema. Patients will be contacted via telephone and will be informed about the study, and the experimental and control groups will be selected through the randomization program among the patients who agree to participate in the study and meet the sampling inclusion criteria. Patients were blinded, and blindness will be achieved in the data analysing stage. All measurements will be made to the experimental and control groups at the same time. The standard lymphedema self-care training will be given to the experimental and the control group. And the experimental group will be educated on how to use the mobile program. When the study is completed, the control group will also be allowed to use the mobile program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| mobile programme users | Experimental | Other: Mobile Lymphedema Self-Care Support Program, Other: standart lymphedema educationPatients will receive and use Mobile Lymphedema Self-Care Support Program application and will receive standart lymphedema education. |
| control group | Active comparator | Other: standart lymphedema educationPatients who will receive standart lymphedema education |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- diagnosed as breast cancer-related lymphedema
- literate,
- having a smart phone,
- completed breast cancer treatment at least six months ago
- volunteering to participate in the study
Key exclusion criteria (6 listed)
- having morbid obesity
- having metastazis
- having dementia
- having other psychiatric conditions
- another health problem that could prevent to exercise
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 |
|---|---|---|
| Mobile Lymphedema Self-Care Support ProgramAlso: standard lymphedema educationThe Mobile Lymphedema Self-Care Support Program is composed of three section. First section includes the information about lymphedema and lymphedema self care. Second section includes the exercises videos which women can concurrently exercise with application and an alarm to remind to exercise. Last section is a social network form the women could chat and share anything with eachother. Patients will be told how to use the Mobile Lymphedema Self-Care Support Program and a contact number will be provided to ask questions about the program at any time. | Other | mobile programme users |
| standart lymphedema educationThe control group will receive standard lymphedema education. The standard lymphedema education is an online education composed of information about lymphedema and lymphedema self-care. | Other | control group, mobile programme users |
Primary outcome
Change in Breast Cancer Related Lymphedema Self-Care Scale Score
Time frame: baseline, 1 month, 3 month
The Breast Related Lymphedema Self-Care Scale is valid and reliable tool. The lowest score is 31, the highest score is 124. Higher scores indicate better self-care.
Change in Quality of Life Measure for Limb Lymphedema-Arm Scale Score
Time frame: baseline, 1 month, 3 month
The Quality of Life Measure for Limb Lymphedema-Arm Scale was translated and cross-culturally adapted to Turkish. The highest score of the scale is 80 and the lowest score is 20. A high score indicates poor quality of life.
Change in Lymphedema Symptom Intensity and Distress Survey Score
Time frame: baseline, 1 month, 3 month
The Turkish version of Lymphedema Symptom Intensity and Distress Survey is valid and reliable. The highest score of the scale is 30 and the lowest score is zero. A high score means experiencing too many symptoms.
1 secondary outcome
Change in Arm circumferences
Time frame: baseline, 1 month, 3 month
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 20 Feb 2024.
- 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.
Özgül Karayurt, PhD study chair
Izmir University of Economics
Sibel Eyigör, MD study chair
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Lymphedema Self-Care Support Program and standart lymphedema education in people with Breast Cancer Related Lymphedema, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 6 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 20 Feb 2024. 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 Turkey (Türkiye). 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?
Change in Breast Cancer Related Lymphedema Self-Care Scale Score (time frame: baseline, 1 month, 3 month). The study lists 3 primary outcomes in all. 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 20 Feb 2024.