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Lymphedema of Upper ArmNCT04138667

Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema

A study testing complex decongestive therapy in people with Lymphedema of Upper Arm, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Lymphedema of Upper Arm
What is being tested?
complex decongestive therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
19 Oct 2019to 30 May 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 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Patients with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3

Who cannot join

  • Bilateral lymphedema
  • The patients who had known systemic edematogenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence
  • Patients with contraindications for application of complex decongestive therapy (active cutaneous infection, deep vein thrombosis, cardiac edema, and peripheral artery disease)

Trial locations and contacts

1 site in 1 country.

Esra Nur Nur Türkmen, PT contact

+905545239830

e.nur5313@hotmail.com

Gulseren Akyuz, Prof contact

+902166570606162

gulserena@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

    Istanbul, 34899

    Esra Giray, MD, +905558134394, girayesra@hotmail.com

    Gulseren Derya Akyuz, Prof, 02166254657 ext. 4657, gulserena@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation and Comparison of Lymphedema Outcome Measurements Validated in Turkish for Assessment of Breast Cancer Related Lymphedema

The aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish.

Read the detailed description

Lymphedema is defined as the excessive and persistent accumulation of fluid, extracellular proteins, and fat in tissue spaces, caused by inefficiency of the lymphatic drainage system. It is a chronic, progressive condition. Several researchers have investigated the influence on health-related quality of life in upper limb lymphedema after breast cancer treatment using patient reported outcome instruments. Responsiveness of only one of the lymphedema assessment scale, ''Lymphedema Quality of Life Inventory'', has been investigated. Responsiveness of lymphedema assessment scales validated in Turkish has not been examined in detail, thereby limiting their use in clinical trials. Therefore, the aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish. Patients with breast cancer related lymphedema with International Society of Lymphology-ISL lymphedema stage 2,3 will be included in the study and will receive complex decongestive therapy phase I including meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist. Limb volume will be calculated based on truncated cone method from circumference measurements. Patients will complete Lymphedema Life Impact Scale (LLIS), Patient Benefit Index-Lymphedema(PBI), Lymphedema functioning, disability and health questionnaire(Lymph-ICF), European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer (EORTC-QLQ-30) and Short Form 36 (SF-36) before and after treatment. Changes in limb volumes will be compared in changes in scales after treatment. Responsiveness of the subscales will be will be determined by calculating the effect size (change in all patients), standardized mean response (effect size in a group with improvement), and Guyatt's Responsiveness Index.

Being tested
complex decongestive therapy
Keywords
breast cancer related lymphedema, lymphedema, outcome measurement, responsiveness
Medical subject headings
Breast Cancer Lymphedema, Lymphedema

What participants receive

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

  • complex decongestive therapyOther

    Complex decongestive therapy-phase 1 program consist of meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist.

Study groups in NCT04138667
Study groupRoleWhat they receive
Patients with post-mastectomy lymphedemaExperimentalPatients with breast cancer related lymphedema who will undergo complex decongestive therapy
Receives: Other: complex decongestive therapy

What is being measured

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

  1. Limb volume measurement

    Limb volume will be calculated based on truncated cone method from circumference measurements

    Measured: before treatment (T0)

  2. Limb volume measurement

    Limb volume will be calculated based on truncated cone method from circumference measurements

    Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

Secondary outcomes (12)
  1. Lymphedema Quality of Life Questionnaire-Arm (LYMQOL)

    The LYMQOL-Arm has been developed to assess the impact of lymphedema of the arms on the QoL of the patients. It consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QoL.

    Measured: before treatment (T0)

  2. Lymphedema Quality of Life Questionnaire-Arm

    The LYMQOL-Arm has been developed to assess the impact of lymphedema of the arms on the QoL of the patients. It consists of four domains with 28 items. These domains are symptoms, appearance, function, and mood. The answers were evaluated on a four-point Likert scale (1= not at all 2= a little, 3= quite a bit, 4= a lot). Each item received a score between 1 and 4, with higher scores indicating a worse QoL.

    Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

  3. Lymphedema Life Impact Scale (LLIS)

    The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.

    Measured: before treatment (T0)

  4. Lymphedema Life Impact Scale (LLIS)

    The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.

    Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

  5. Patient Benefit Index-Lymphedema(PBI)

    The Patient Benefit Index (PBI) methodology allows for a more direct measurement of patient-relevant treatment.benefit. In the first part the Patient Needs Questionnaire (PNQ)patients rate the importance of a list of patient relevant treatment goals on a five-step scale from "not at all" to "very". In the second part the Patient Benefit Questionnaire (PBQ) patients rate to what extent the treatment goals have been achieved on the same five-step scale. Alternatively, they can choose "does not apply to me" for each treatment goal in both questionnaires. Thus, the patient directly evaluates treatment benefit instead of rating her/his current HRQoL before and after treatment. A PBI weighted global score ranging from 0 (no benefit) to 4 (maximum benefit) is computed for each patient. The weighting algorithm8 ensures that the achievement of important treatment goals will have higher impact on the global score than the achievement of less important goals.

    Measured: before treatment (T0)

  6. Patient Benefit Index-Lymphedema(PBI)

    The Patient Benefit Index (PBI) methodology allows for a more direct measurement of patient-relevant treatment.benefit. In the first part the Patient Needs Questionnaire (PNQ) patients rate the importance of a list of patient relevant treatment goals on a five-step scale from "not at all" to "very". In the second part the Patient Benefit Questionnaire (PBQ) patients rate to what extent the treatment goals have been achieved on the same five-step scale. Alternatively, they can choose "does not apply to me" for each treatment goal in both questionnaires. Thus, the patient directly evaluates treatment benefit instead of rating her/his current HRQoL before and after treatment. A PBI weighted global score ranging from 0 (no benefit) to 4 (maximum benefit) is computed for each patient. The weighting algorithm8 ensures that the achievement of important treatment goals will have higher impact on the global score than the achievement of less important goals.

    Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

  7. Lymphoedema functioning, disability and health questionnaire(Lymph-ICF)

    The Lymph-ICF questionnaire is composed of 29 questions. Each question is answered using a visual analog scale (VAS) ranging from 0 to 100 mm. The anchors for the impairments in function (e.g. "Does your arm hurt?") are "not at all" and "very much," and those for the activity limitations and participation restrictions (e.g. "Are you able to carry heavy weights?") are "very well" and "not at all." The Lymph-ICF has 5 domains: physical function, mental function, household activities, mobility activities, and life and social activities. The total score of the Lymph-ICF is equal to the sum of the scores of the questions divided by the total number of answered questions.

    Measured: before treatment (T0)

  8. Lymphoedema functioning, disability and health questionnaire(Lymph-ICF)

    The Lymph-ICF questionnaire is composed of 29 questions. Each question is answered using a visual analog scale (VAS) ranging from 0 to 100 mm. The anchors for the impairments in function (e.g. "Does your arm hurt?") are "not at all" and "very much," and those for the activity limitations and participation restrictions (e.g. "Are you able to carry heavy weights?") are "very well" and "not at all." The Lymph-ICF has 5 domains: physical function, mental function, household activities, mobility activities, and life and social activities. The total score of the Lymph-ICF is equal to the sum of the scores of the questions divided by the total number of answered questions.

    Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

  9. European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30)

    The EORTC QLQ-C30 questionnaire is a survey conducted to evaluate the quality of life in patients with breast cancer. It consists of 30 questions which assess symptoms that occurred in the previous two weeks. Responses are given on a Likert scale: 1 - not at all, 2 - a little, 3 - quite a bit, 4 - very much. The global health scale consists of two questions asking patients to classify their general health and quality of life in the previous week, by rating it from 1 to 7, in which 1 means poor and 7, excellent. The questionnaires are divided into three scales: global health scale (GHS), functional scale (FS) and symptom scale (SS).

    Measured: before treatment (T0)

  10. European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30)

    The EORTC QLQ-C30 questionnaire is a survey conducted to evaluate the quality of life in patients with breast cancer. It consists of 30 questions which assess symptoms that occurred in the previous two weeks. Responses are given on a Likert scale: 1 - not at all, 2 - a little, 3 - quite a bit, 4 - very much. The global health scale consists of two questions asking patients to classify their general health and quality of life in the previous week, by rating it from 1 to 7, in which 1 means poor and 7, excellent. The questionnaires are divided into three scales: global health scale (GHS), functional scale (FS) and symptom scale (SS).

    Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

  11. Short Form 36 (SF-36)

    The Short Form 36 (SF-36) Health Survey measures overall health. It has eight sections: Physical functioning (10), role limitations due to physical health (4), role limitations due to emotional problems (3), energy/fatigue (4), emotional well-being (5), social functioning (2), pain (2), and general health (5). Each scale is transformed into a 0-100 scale on the assumption that each scale carries equal weight. The lower the score, the more disability.

    Measured: before treatment (T0)

  12. Short Form 36 (SF-36)

    The Short Form 36 (SF-36) Health Survey measures overall health. It has eight sections: Physical functioning (10), role limitations due to physical health (4), role limitations due to emotional problems (3), energy/fatigue (4), emotional well-being (5), social functioning (2), pain (2), and general health (5). Each scale is transformed into a 0-100 scale on the assumption that each scale carries equal weight. The lower the score, the more disability.

    Measured: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

Timeline

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

  1. First posted24 Oct 2019
  2. Study start19 Oct 2019
  3. Primary completion30 May 2020 (estimated)
  4. Study completion30 May 2020 (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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Patients with breast cancer related lymphedema who will undergo complex decongestive phase 1
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04138667
Sponsor's protocol ID
09.2019.865
Status last verified
Oct 2019
First submitted
19 Oct 2019
Last updated
24 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The investigators don't plan to share individual participant data (IPD) in public.

Publications

  • Menz HB, Auhl M, Tan JM, Levinger P, Roddy E, Munteanu SE. Comparative Responsiveness of Outcome Measures for the Assessment of Pain and Function in Osteoarthritis of the First Metatarsophalangeal Joint. Arthritis Care Res (Hoboken). 2020 May;72(5):679-684. doi: 10.1002/acr.23883. Epub 2020 Apr 8.

    PubMed 30908853
  • Borman P, Yaman A, Denizli M, Karahan S, Ozdemir O. The reliability and validity of Lymphedema Quality of Life Questionnaire-Arm in Turkish patients with upper limb lymphedema related with breast cancer. Turk J Phys Med Rehabil. 2018 Jul 9;64(3):205-212. doi: 10.5606/tftrd.2018.2843. eCollection 2018 Sep.

    PubMed 31453513
  • Duygu E, Bakar Y, Keser I. An Important Tool in Lymphedema Management: Validation of Turkish Version of the Patient Benefit Index-Lymphedema. Lymphat Res Biol. 2020 Feb;18(1):49-55. doi: 10.1089/lrb.2018.0036. Epub 2019 May 30.

    PubMed 31145018
  • Bakar Y, Tugral A. Translation, reliability, and validation of the Turkish version of the Lymphedema Quality-of-Life tool in Turkish-speaking patients with lower limb Lymphedema. J Vasc Nurs. 2019 Mar;37(1):11-17. doi: 10.1016/j.jvn.2018.11.005. Epub 2019 Jan 31.

    PubMed 30954192
  • Bakar Y, Tugral A, Ozdemir O, Duygu E, Uyeturk U. Translation and Validation of the Turkish Version of Lymphedema Quality of Life Tool (LYMQOL) in Patients with Breast Cancer Related Lymphedema. Eur J Breast Health. 2017 Jul 1;13(3):123-128. doi: 10.5152/ejbh.2017.3522. eCollection 2017 Jul.

    PubMed 28894851
  • Kostanoglu A, Hosbay Z, Tarakci E. Lymphoedema functioning, disability and health questionnaire Turkish version: translation, cross-cultural adaptation and validation. J Phys Ther Sci. 2016 Jun;28(6):1728-32. doi: 10.1589/jpts.28.1728. Epub 2016 Jun 28.

    PubMed 27390404

Questions about this trial

What is this clinical trial studying?

A study testing complex decongestive therapy in people with Lymphedema of Upper Arm, run by Marmara 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Oct 2019. 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?

Results are not available in the source record.

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

Contact Esra Nur Nur Türkmen, PT (+905545239830, e.nur5313@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Limb volume measurement (time frame: before treatment (T0)). 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 NCT04138667, which also lists 6 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 24 Oct 2019.

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