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Breast Cancer Related LymphedemamobiLymphfNCT06507033

Development of the Wearable Arm Volume Measurement Device and Mobile Application

A study testing Mobile application and an arm volume measurement device in people with Breast Cancer Related Lymphedema, run by Ayşe ARIKAN DÖNMEZ.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

With the increase in the incidence of cancer in our country and the world, the number of breast cancer survivors is increasing rapidly due to the development of early diagnosis and treatment methods. One of the main problems in breast cancer survivors is lymphedema. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Related Lymphedema
What is being tested?
Mobile application and an arm volume measurement device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
No sites listed yet
Study dates
Sep 2024to Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • To agree to take part in the research,
  • Breast surgery including lymph node dissection within the last 6 months,
  • To be 18 years of age or older,
  • To be able to communicate in Turkish,
  • Using a smartphone with Android operating system,
  • No cognitive/cognitive impairment (electronic records of patients will be taken as basis)

Who cannot join

  • Patients who do not meet the inclusion criteria will be excluded from the study

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ayşe Arıkan Dönmez, PhD; RN contact

05309260117

aysearikan8585@gmail.com

About this study

Official title: Development of the Wearable Arm Volume Measurement Device and Mobile Application (mobiLymphf) in the Prevention and Early Detection of Breast Cancer-related Lymphedema and Evaluation of Their Efficiency

With the increase in the incidence of cancer in our country and the world, the number of breast cancer survivors is increasing rapidly due to the development of early diagnosis and treatment methods. One of the main problems in breast cancer survivors is lymphedema. Breast cancer-related lymphedema is a condition that can be treated when detected early, but has a very low success rate when detected in advanced stages. Therefore, the prevention and early detection of breast cancer-associated lymphedema is very important. In this project, it is aimed to prevent breast cancer-related lymphedema with the mobile application to be developed and to detect the volume increase in the arm before clinical findings with an arm volume measurement device that will work with this mobile application. The project consists of two main steps; (a)development of the arm volume measuring device and mobile application (b)evaluation of the effectiveness of the products. Five components will be involved in the development of the mobile application. These components are; (I)exercise, (II)education, (III)coping mechanisms, (IV)arm volume measurement/records, and (V)reminder for exercise, measurement, and follow-ups. Exercise videos will include stretching exercises for the shoulder and arm area as recommended in the guides. The training content will be created in line with the guides and opinions will be taken from an expert panel. In support of coping mechanisms, existing problem areas in people will be determined with a qualitative study. People who have gone through a similar process in the past will be asked about the coping strategies they have developed for these problem areas. Themes obtained from patients who have gone through a similar process in the past (lymph node dissection due to breast cancer) and suggestions of the guidelines will be presented in the mobile application. In arm volume measurement, a wearable technology product to be designed in the form of an arm cuff and strain sensors to be placed on the arm will detect the increase in arm circumference. After Summary With the increase in the incidence of cancer in our country and the world, the number of breast cancer survivors is increasing rapidly due to the development of early diagnosis and treatment methods. One of the main problems in breast cancer survivors is lymphedema. Breast cancer-related lymphedema is a condition that can be treated when detected early, but has a very low success rate when detected in advanced stages. Therefore, the prevention and early detection of breast cancer-associated lymphedema is very important. In this project, it is aimed to prevent breast cancer-related lymphedema with the mobile application to be developed and to detect the volume increase in the arm before clinical findings with an arm volume measurement device that will work with this mobile application. The project consists of two main steps; (a)development of the arm volume measuring device and mobile application (b)evaluation of the effectiveness of the products. Five components will be involved in the development of the mobile application. These components are; (I)exercise, (II)education, (III)coping mechanisms, (IV)arm volume measurement/records, and (V)reminder for exercise, measurement, and follow-ups. Exercise videos will include stretching exercises for the shoulder and arm area as recommended in the guides. The training content will be created in line with the guides and opinions will be taken from an expert panel. In support of coping mechanisms, existing problem areas in people will be determined with a qualitative study. People who have gone through a similar process in the past will be asked about the coping strategies they have developed for these problem areas. Themes obtained from patients who have gone through a similar process in the past (lymph node dissection due to breast cancer) and suggestions of the guidelines will be presented in the mobile application. In arm volume measurement, a wearable technology product to be designed in the form of an arm cuff and strain sensors to be placed on the arm will detect the increase in arm circumference. After measuring the arm circumference with the sensors located every five centimeters, the arm volume will be calculated with the cylindrical volume calculation method. When there is an increase of 5% or more in the arm of the individual (preclinical lymphedema), a notification will be sent to the person and his/her physician via the mobile application. The person will also be able to follow the past measurement results via the mobile application. Evaluation of the efficacy of the product will be based on a pilot randomized controlled trial, a reproducibility study, and patient feedback. This product to be developed will provide a new arm volume measurement method that will reduce patients' hospital admissions and will contribute to the prevention and early detection of lymphedema.

Read the detailed description

Stage 1 - Development of Arm Volume Measurement Device and Mobile Application; In this stage, the preparation of the mobile application content, the development of the arm volume measurement device and the establishment of the connection unit will be started. Then, these systems will be brought together and feedback will be received from the survivors. In this process, initially 5 lines of work will be carried out simultaneously in the research. These tasks are (1) creation of exercise content and videos, (2) creation of training content, (3) determination of the problem areas experienced by breast cancer survivors through qualitative interviews and determination of the solutions applied by the survivors themselves for these problem areas, (4) development and calibration of the strain sensor and connection unit, 5) expert and user opinions will be taken for the developed mobile application.

Stage 2 - Evaluation of the Effectiveness of the Developed Product; Three simultaneous evaluations will be used in this phase. For this, there will be two research and one end-user feedback. These are; (6) feedback from survivors on satisfaction, usefulness and usefulness after using the product, (7) a pilot randomised controlled trial to evaluate the effectiveness of the developed product and (8) a reproducibility study comparing the developed product with the existing volume measurement method.

Being tested
Mobile application and an arm volume measurement device
Keywords
Breast Cancer, Lymphedema, Wearable Technology, Mobile Application, Nursing
Medical subject headings
Breast Cancer Lymphedema, Breast Neoplasms, Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile application and an arm volume measurement deviceDevice

    The intervention consists mainly of two steps; (a) development of a mobile application with an arm volume measurement device (b) evaluation of the effectiveness of the products. Five components will be involved in the development of the mobile application. These components are; (I) exercise, (II) education, (III) coping mechanisms, (IV) arm volume measurement/recording and (V) appointment, exercise and measurement reminder panel. Exercise videos will include stretching exercises for the shoulder and arm as recommended in the guidelines

Study groups in NCT06507033
Study groupRoleWhat they receive
Intervention GroupExperimentalThis group will be provided with the mobile application and volume measurement device. The planning for hospital visits will be organised at the same frequency in both groups. All individuals will be followed up for three months. The same measurement tools will be applied to both groups before and after the application.
Receives: Device: Mobile application and an arm volume measurement device
Control GroupNo interventionThis group will receive routine care at the clinic.The planning for hospital visits will be organised at the same frequency in both groups. All individuals will be followed up for three months. The same measurement tools will be applied to both groups before and after the application.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disability of Arm, Shoulder and Hand- DASH

    The first section contains 30 questions, of which 21 questions assess difficulties experienced in activities of daily living, 5 questions assess symptoms and 4 questions assess social functioning, work, sleep and patient confidence. This section determines the patient's function/symptom status and is referred to as the DASH-FS.

    Measured: It will be applied to the participants at baseline, as well as at the 25th month and 33th month follow ups.

  2. Adult Life Quality Scale in Cancer Survivors

    Consisting of 47 items and 12 sub-dimensions, the items in the scale are answered in 7-point Likert type. The scale consists of two parts: general and cancer-specific quality of life. Of these 12 sub-dimensions, 7 are related to general quality of life and 5 are related to cancer-specific quality of life.

    Measured: It will be applied to the participants at baseline, as well as at the 25th month and 33th month follow ups.

  3. Positive Affectivity, Negative Affectivity Scale - PANAS

    The 10 affect states of Excited, Strong, Enthusiastic, Proud, Alert, Inspired, Determined, Active, Concerned, and Attentive measure positive affect; the 10 affect states of Distressed, Unhappy, Guilty, Frightened, Hostile, Irritable, Embarrassed, Nervous, Agitated, and Scared measure negative affect.

    Measured: It will be applied to the participants at baseline, as well as at the 25th month and 33th month follow ups.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionMay 2025 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06507033
Sponsor's protocol ID
223S524
Acronym
mobiLymphf
Status last verified
Jul 2024
First submitted
27 Jun 2024
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Mobile application and an arm volume measurement device in people with Breast Cancer Related Lymphedema, run by Ayşe ARIKAN DÖNMEZ.

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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ayşe Arıkan Dönmez, PhD; RN (05309260117, aysearikan8585@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disability of Arm, Shoulder and Hand- DASH (time frame: It will be applied to the participants at baseline, as well as at the 25th month and 33th month follow ups.). 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 18 Jul 2024.

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