Lymphedema of Upper LimbNCT06036173
Body Awareness and Functionality in Lymphedema
An observational study of Lymphedema of Upper Limb, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
To determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Lymphedema of Upper Limb
- What is being tested?
- diagnosis of lymphedema and breast cancer surgery
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Aug 2023to 27 Oct 2023
- Phase
- Observational
- 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 to 65 years
- Women only
- Adult, Older adult
Study population: being a woman and having had breast cancer surgery
Who may be able to join
- first group:
- being female,
- being aged 18-65 years,
- having undergone unilateral breast cancer surgery,
- being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
- not having any orthopedic disease that would prevent walking, and volunteering to participate in the study.
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- second group:The inclusion criteria for the breast cancer surgery group
- without lymphedema were being female,
- being aged 18-65 years,
- having undergone unilateral breast cancer surgery, and volunteering to participate in the study.
- Lastly, the inclusion criteria for the control group were:
- being female,
- being aged 18-65 years,
- having no history of cancer surgery, and volunteering to participate in the study.
Who cannot join
- not being willing to participate in the study;
- the presence of metastases, neurological, or orthopedic disorders;
- postural deformities, such as scoliosis and kyphosis;
- mental and cognitive disorders; or communication/cooperation problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Lymphedema After Breast Cancer Treatment on Body Awareness and Upper Extremity Functionality
To determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer.
- Conditions
- Lymphedema of Upper Limb
- Being tested
- diagnosis of lymphedema, breast cancer surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis of lymphedemaOther
being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
breast cancer surgeryOther
be diagnosed and undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| developed lymphedema after breast cancer surgery | Not described Receives: Other: diagnosis of lymphedema; Other: breast cancer surgery | |
| did not develop lymphedema after breast cancer surgery | Not described Receives: Other: breast cancer surgery | |
| without a history of any cancer surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Awareness Questionnaire
This instrument consists of a total of 18 items evaluated based on a scale of 1 (not at all true of me) to 7 (very true of me). The total score is obtained by adding the scores of each item. A higher total score indicates better body awareness. Max/ min score:126/18
Measured: 17 minutes
Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire
Each of the 11 items in this instrument is scored from 1 to 5. The responses given to all items are summed up, and the total score is obtained with a special formula. A high total score indicates a high level of functional limitation. Max/ min score: 100/0
Measured: 11 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start16 Aug 2023
- Primary completion30 Sep 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of Upper LimbStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Cihan, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036173
- Sponsor's protocol ID
- 2023/09.06
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lymphedema After Breast Cancer Treatment on Body Awareness and Upper Extremity Functionality
- ClinicalTrials.gov ID
- NCT06036173
- Acronym / sponsor ID
- 2023/09.06
- Conditions
- Lymphedema of Upper Limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 13 Sep 2023 (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 determine whether body awareness and upper extremity functionality are affected in patients with or without lymphedema development after breast cancer surgery in comparison with individuals without a history of cancer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| developed lymphedema after breast cancer surgery | – | Other: diagnosis of lymphedema, Other: breast cancer surgery |
| did not develop lymphedema after breast cancer surgery | – | Other: breast cancer surgery |
| without a history of any cancer surgery | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- being a woman and having had breast cancer surgery
Key inclusion criteria (14 listed)
- being female,
- being aged 18-65 years,
- having undergone unilateral breast cancer surgery,
- being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
- not having any orthopedic disease that would prevent walking, and volunteering to participate in the study.
Key exclusion criteria (4 listed)
- not being willing to participate in the study;
- the presence of metastases, neurological, or orthopedic disorders;
- postural deformities, such as scoliosis and kyphosis;
- mental and cognitive disorders; or communication/cooperation problems
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 |
|---|---|---|
| diagnosis of lymphedemabeing diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association | Other | developed lymphedema after breast cancer surgery |
| breast cancer surgerybe diagnosed and undergo surgery | Other | developed lymphedema after breast cancer surgery, did not develop lymphedema after breast cancer surgery |
Primary outcome
Body Awareness Questionnaire
Time frame: 17 minutes
This instrument consists of a total of 18 items evaluated based on a scale of 1 (not at all true of me) to 7 (very true of me). The total score is obtained by adding the scores of each item. A higher total score indicates better body awareness. Max/ min score:126/18
Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire
Time frame: 11 minutes
Each of the 11 items in this instrument is scored from 1 to 5. The responses given to all items are summed up, and the total score is obtained with a special formula. A high total score indicates a high level of functional limitation. Max/ min score: 100/0
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 13 Nov 2023.
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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?
An observational study of Lymphedema of Upper Limb, run by Selcuk 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 14 inclusion and 4 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 13 Nov 2023. 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?
Body Awareness Questionnaire (time frame: 17 minutes). 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?
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 13 Nov 2023.