Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema

October 23, 2019 updated by: Marmara University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
        • Contact:
        • Principal Investigator:
          • Gulseren Derya Akyuz, Prof
        • Sub-Investigator:
          • Esra Giray, MD
        • Principal Investigator:
          • Esra Nur Türkmen, PT
        • Sub-Investigator:
          • İlker Yagci, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with post-mastectomy lymphedema
Patients with breast cancer related lymphedema who will undergo complex decongestive therapy
Other: complex decongestive therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limb volume measurement
Time Frame: before treatment (T0)
Limb volume will be calculated based on truncated cone method from circumference measurements
before treatment (T0)
Limb volume measurement
Time Frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymphedema Quality of Life Questionnaire-Arm (LYMQOL)
Time Frame: before treatment (T0)
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.
before treatment (T0)
Lymphedema Quality of Life Questionnaire-Arm
Time Frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
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.
after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Lymphedema Life Impact Scale (LLIS)
Time Frame: before treatment (T0)
The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.
before treatment (T0)
Lymphedema Life Impact Scale (LLIS)
Time Frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
The LLIS is an 18-item measure of physical, psychosocial, and functional impairments caused by lymphedema.
after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Patient Benefit Index-Lymphedema(PBI)
Time Frame: before treatment (T0)
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.
before treatment (T0)
Patient Benefit Index-Lymphedema(PBI)
Time Frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
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.
after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Lymphoedema functioning, disability and health questionnaire(Lymph-ICF)
Time Frame: before treatment (T0)
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.
before treatment (T0)
Lymphoedema functioning, disability and health questionnaire(Lymph-ICF)
Time Frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
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.
after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30)
Time Frame: before treatment (T0)
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).
before treatment (T0)
European Organization for Research and Treatment of Cancer QoL Breast Cancer (EORTC-QLQ-30)
Time Frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
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).
after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
Short Form 36 (SF-36)
Time Frame: before treatment (T0)
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.
before treatment (T0)
Short Form 36 (SF-36)
Time Frame: after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)
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.
after treatment (T1) (through completion of four weeks of complex decongestive therapy phase 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2019

Primary Completion (Anticipated)

May 30, 2020

Study Completion (Anticipated)

May 30, 2020

Study Registration Dates

First Submitted

October 19, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 24, 2019

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2019.865

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The investigators don't plan to share individual participant data (IPD) in public.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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