Psychometric Properties of a Lymphedema-specific Quality of Life Questionnaire in Lower Limb Lymphedema

NCT07075549 | Completed

• 1 other identifier: S67308
• Study Type: observational
• Target: 451
• Locations: 2 countries
• Sites: 3

Brief Summary

The goal of this observational study is to cross-validate the Lymphedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphedema (Lymph-ICF-LL) in French and to investigate the responsiveness of the original Dutch Lymph-ICF-LL questionnaire in patients with lower limb lymphedema. The main questions it aims to answer are:

1. 1.The reliability of the French Lymph-ICF-LL
2. 2.The validity of the French Lymph-ICF-LL
3. 3.The responsiveness of the original Dutch Lymph-ICF-LL

Conditions

Lymphedema Lower Extremity

Keywords

Reliability; Validity; Responsiveness; Quality of Life; Questionnaire; Lymphedema; Lower Limb

Outcome Measures

Primary Outcomes (4)

• Reliability of the French Lymph-ICF-LL questionnaire (test-retest)

  Following aspects were assessed to investigate the reliability of the French Lymph-ICF-LL: Test-retest relative reliability Patients completed the Lymph-ICF-LL two times with an interval of 1-2 days. The total score and subdomain scores are calculated: (sum of scores divided by the number of completed questions)\*10. This results in a score between 0 and 100 in which 0 reflects a better lymphedema-specific quality of life and 100 a worse lymphedema-specific quality of life. The intraclass correlation coefficient (2,1) (ICC) is calculated between the first and second completion. An ICC above .90 is interpreted as excellent relative reliability, an ICC between .75 and .90 as good, an ICC between .50 and .75 as moderate and an ICC below .50 as poor relative reliability.

  Baseline and 1-2 days later

• Reliability of the French Lymph-ICF-LL questionnaire (standard error of measurement)

  Standard error of measurement (SEM) reflects absolute reliability between the total and subdomain scores of the Lymph-ICF-LL questionnaires at baseline and 1-2 days later. The SEM is calculated with the square root of mean square error determined by ANOVA.

  Baseline and 1-2 days later

• Reliability of the French Lymph-ICF-LL questionnaire (smallest real difference)

  Smallest Real Difference (SRD) between the total and subdomain scores of the two Lymph-ICF-LL questionnaire completions at baseline and 1-2 days later was calculated by 1.96 multiplied by SEM and square root of 2.

  Baseline and 1-2 days later

• Reliability of the French Lymph-ICF-LL questionnaire

  Internal consistency with Cronbach's alpha of the different domains and total score. A Cronbach's alpha between .70 and .90 is considered as a good internal consistency

  Baseline (first completion of the Lymph-ICF-LL questionnaire)

Secondary Outcomes (4)

• Face and content/floor & ceiling effects of the French Lymph-ICF-LL

  Baseline

• Construct validity of the Lymph-ICF-LL

  Baseline

• Internal responsiveness of the Lymph-ICF-LL

  At start of the intensive phase and 1 month after the end of the intensive phase (patients receiving intensive treatment) or at baseline and 2 months later (patients with stable lower limb lymphedema)

• External responsiveness

  Start of the intensive phase and 1 month after the end of the intensive phase (patients receiving intensive treatment) or baseline an 2 months later (patients with stable lower limb lymphedema in the stable phase)

Study Arms (4)

Native French speaking patients with stable lower limb lymphedema in the maintenance phase

Native French speaking patients with stable lower limb lymphedema in the maintenance phase were included for the reliability, validity and responsiveness of the French Lymph-ICF-LL

Other: Maintenance phase of Decongestive Lymphatic Therapy

Native French speaking patients with lower limb lymphedema which are treated in the intensive phase

Native French speaking patients with lower limb lymphedema who received treatment in the intensive phase were included for the responsiveness of the French Lymph-ICF-LL

Other: Intensive phase of Decongestive Lymphatic Therapy

Native Dutch speaking patients with stable lower limb lymphedema in the maintenance phase

Native Dutch speaking patients with stable lower limb lymphedema in the maintenance phase were included for the responsiveness of the Dutch Lymph-ICF-LL

Other: Maintenance phase of Decongestive Lymphatic Therapy

Native Dutch speaking patients with lower limb lymphedema which are treated in the intensive phase

Native Dutch speaking patients with lower limb lymphedema who received treatment in the intensive phase were included for the responsiveness of the Dutch Lymph-ICF-LL

Other: Intensive phase of Decongestive Lymphatic Therapy

Interventions

Maintenance phase of Decongestive Lymphatic Therapy OTHER

Patients with lower limb lymphedema in the maintenance phase of decongestive lymphatic therapy (with compression garments) were included

Native Dutch speaking patients with stable lower limb lymphedema in the maintenance phase; Native French speaking patients with stable lower limb lymphedema in the maintenance phase

Intensive phase of Decongestive Lymphatic Therapy OTHER

Patients with lower limb lymphedema who are treated in the intensive phase of Decongestive Lymphatic Therapy (with multilayer bandages) were included

Native Dutch speaking patients with lower limb lymphedema which are treated in the intensive phase; Native French speaking patients with lower limb lymphedema which are treated in the intensive phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with lower limb lymphedema are treated with decongestive lymphatic therapy and are either in the intensive phase or in the maintenance phase. Patients in both phases are included in this study.

You may qualify if:

• Primary or secondary lymphedema at the lower limb(s), i.e. a difference of ≥5% in volume between the two sides or a lymphoscintigraphy which shows at least 2 minor criteria or 1 major criterion or presence of indocyanine green (ICG) dermal backflow
• Unilateral/bilateral lymphedema
• Lymphedema stage 1, 2a, 2b or 3
• Lymphedema is present \>3 months
• Chemotherapy and radiotherapy was finished \>3 months ago
• Native French-speaking or Dutch-speaking for study about the French or Dutch Lymph-ICF-LL, respectively
• During the study patients are in the maintenance phase and not in the intensive phase (for the reliability/validity/responsiveness); patients receive intensive treatment in the hospital (for the responsiveness)
• Given informed consent to participate
• \>18 years old

You may not qualify if:

• Not able to read or fully understand the French or Dutch language for study about the French or Dutch Lymph-ICF-LL, respectively
• For the reliability and validity and for part of the responsiveness: first treatment for lymphedema \< 6 months ago and an intensive phase is planned or needed according to a specialized caregiver in treating lymphedema
• \<18 years old
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• CHU UCL Namur: collaborator

Study Sites (3)

UZ Leuven and KU Leuven

Leuven, 3000, Belgium

Location

CHU UCL Namur site Godinne

Yvoir, 5332, Belgium

Location

Hôpital Cognacq-Jay

Paris, 75015, France

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 20, 2025
• Study Start: April 10, 2025
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-07

Locations

FR (1); BE (2)