Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema

NCT04138667 | Unknown

• 1 other identifier: 09.2019.865
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema of Upper Arm

Keywords

breast cancer related lymphedema; lymphedema; outcome measurement; responsiveness

Outcome Measures

Primary Outcomes (2)

• Limb volume measurement

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

  before treatment (T0)

• Limb volume measurement

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

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

Secondary Outcomes (12)

• Lymphedema Quality of Life Questionnaire-Arm (LYMQOL)

  before treatment (T0)

• Lymphedema Quality of Life Questionnaire-Arm

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

• Lymphedema Life Impact Scale (LLIS)

  before treatment (T0)

• Lymphedema Life Impact Scale (LLIS)

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

• Patient Benefit Index-Lymphedema(PBI)

  before treatment (T0)

Study Arms (1)

Patients with post-mastectomy lymphedema

EXPERIMENTAL

Patients with breast cancer related lymphedema who will undergo complex decongestive therapy

Other: complex decongestive therapy

Interventions

complex decongestive therapy OTHER

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.

Patients with post-mastectomy lymphedema

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 30908853 RESULT

• 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.

  PMID: 31453513 RESULT

• 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.

  PMID: 31145018 RESULT

• 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.

  PMID: 30954192 RESULT

• 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.

  PMID: 28894851 RESULT

• 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.

  PMID: 27390404 RESULT

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gulseren Akyuz, Prof

  Marmara University

  STUDY CHAIR

Central Study Contacts

Esra Nur Nur Türkmen, PT

CONTACT

+905545239830; e.nur5313@hotmail.com

Gulseren Akyuz, Prof

CONTACT

+902166570606162; gulserena@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with breast cancer related lymphedema who will undergo complex decongestive phase 1

Study Record Dates

• First Submitted: October 19, 2019
• First Posted: October 24, 2019
• Study Start: October 19, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: October 24, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)