Lymphedema Lower ExtremityNCT07075549
Psychometric Properties of a Lymphedema-specific Quality of Life Questionnaire in Lower Limb Lymphedema
An observational study of Lymphedema Lower Extremity, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema Lower Extremity
- What is being tested?
- Maintenance phase of Decongestive Lymphatic Therapy and Intensive phase of Decongestive Lymphatic Therapy
- How many people
- 451 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Apr 2025to 10 Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
UZ Leuven and KU Leuven
Leuven, 3000
CHU UCL Namur site Godinne
Yvoir, 5332
About this study
Official title: Cross-cultural Validation of the French Version of the Lymphedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphedema (Lymph-ICF-LL) and Responsiveness of the Dutch Version of the Lymph-ICF-LL
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:
- The reliability of the French Lymph-ICF-LL
- The validity of the French Lymph-ICF-LL
- The responsiveness of the original Dutch Lymph-ICF-LL
Participants are asked to complete questionnaires (Lymph-ICF-LL, Short Form-36, Global Perceived Effect Scale, questionnaire about the face and content validity) at two time points.
Read the detailed description
- For reliability of the French Lymph-ICF-LL questionnaire: Native French speaking patients with stable lower limb lymphedema (LLL) (= in the maintenance phase of the treatment and no intensive multicomponent bandaging is required) are asked to complete the Lymph-ICF-LL questionnaire twice with an interval of 1-2 days in between. For the test-retest reliability following outcomes are calculated: Intraclass Correlation Coefficient(2,1), standard error of measurement and the smallest real difference. For internal consistency the Cronbach's alpha is calculated for the first completion of the questionnaire.
- For the validity of the French Lymph-ICF-LL questionnaire, the construct validity, face and content validity are determined. 2.1: For construct validity (=convergent and divergent validity), patients with stable lower limb lymphedema are asked to additionally complete the 36-item Short-Form Health survey (=health-related quality of life questionnaire) together with the first completion of the Lymph-ICF-LL questionnaire. For convergent validity, hypotheses are formulated about significant correlations between domains of the 36-item Short-Form Health survey (=SF-36) and domains of the Lymph-ICF-LL questionnaire which are expected to evaluate a similar construct: 'Physical functioning' of SF-36 and 'general tasks/household', 'mobility', 'life domains/social life' of the Lymph-ICF-LL; 'Role limitations due to physical health problems' of SF-36 and 'General tasks/household' of Lymph-ICF-LL; 'Bodily pain' of SF-36 and 'Physical function' of Lymph-ICF-LL; 'Social functioning' of SF-36 and 'Life domains/ social life' of Lymph-ICF-LL; 'Role limitations due to personal or emotional problems' of SF-36 and 'Mental function' of Lymph-ICF-LL; 'Mental health' of SF-36 and 'Mental function' of Lymph-ICF-LL. For divergent validity, hypotheses are formulated about weak or non-significant correlations between domains of the SF-36 and Lymph-ICF-LL: 'Physical functioning' of SF-36 and 'Mental function' of Lymph-ICF-LL; 'Role limitations due to personal or emotional problems' of SF-36 and 'Physical function' Lymph-ICF-LL; 'Mental health' of SF-36 and 'General tasks/household', 'Mobility', 'Life domains/social life' of Lymph-ICF-LL. These hypotheses were also used in previous published research of the validation of the original Dutch Lymph-ICF-LL questionnaire. Spearman rank correlation coefficients were calculated for this purpose.A correlation coefficient below .25 represent no to a little relationship, a value between .25 and .50 indicates a low to fair relationship, a value between .50 and .75 is interpreted as a moderate to good relationship and a value above or equal to .75 as a strong relationship. 2.2 For face and content validity, patients with stable LLL are asked to complete an additional questionnaire about clarity and completeness of the Lymph-ICF-LL questionnaire: "Was each question of the Lymph-ICF-LL understandable? (yes/no)", "Was the scoring system clear? (yes/no)", "Were all complaints related to your lymphedema mentioned in the questionnaire? (yes/no)" and "Where there any questions of which you thought they were not relevant for lymphedema? (yes/no)". If patients answered 'no', they could clarify their answer in an open field.
- For the responsiveness of the French and Dutch Lymph-ICF-LL, internal and external responsiveness is evaluated in patients with stable LLL and in patients who are treated in the intensive phase with multicomponent bandages. For internal responsiveness, patients with stable LLL have to complete the Lymph-ICF-LL questionnaire twice with an interval of 2 months. Patients treated in the intensive phase have to complete the questionnaire at the start of the intensive phase and 1 month after the end of the intensive phase. The Wilcoxon signed rank test is determined to evaluate if there is a significant difference between the total and subdomain scores of two completions in patients in the intensive phase and not in patients with LLL. For the external responsiveness, all patients are asked to complete the Global Perceived effect scale (GPE) together with the second completion of the Lymph-ICF-LL questionnaire. In this GPE questionnaire patient are asked to rate their perceived change in lymphedema-specific quality of life in general and concerning the subdomains of the Lymph-ICF-LL on a 7-point Likert-scale: 1=completely recovered, 2=much better, 3= a little better, 4= unchanged, 5= a little worse, 6= much worse, 7= worse than ever. Patients who give score 1 and 2 are labeled as responders, with score 3-5 as non-responders and with scere 6-7 as negative responders. The Wilcoxon signed rank test was determined between the total and subdomain scores in the positive, negative and non responder groups. Additionally spearman rank correlations coefficients are calculated between the change in total and subdomain scores and the GPE-score. The minimal clinically important difference are calculated with the anchor-based method: descriptive statistics of the change in total and subdomain scores of the Lymph-ICF-LL are determined in patients who indicated on the GPE that the lymphedema-specific quality of life was much improved or much worsened.
- Conditions
- Lymphedema Lower Extremity
- Being tested
- Maintenance phase of Decongestive Lymphatic Therapy, Intensive phase of Decongestive Lymphatic Therapy
- Keywords
- Reliability, Validity, Responsiveness, Quality of Life, Questionnaire, Lymphedema, Lower Limb
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maintenance phase of Decongestive Lymphatic TherapyOther
Patients with lower limb lymphedema in the maintenance phase of decongestive lymphatic therapy (with compression garments) were included
Intensive phase of Decongestive Lymphatic TherapyOther
Patients with lower limb lymphedema who are treated in the intensive phase of Decongestive Lymphatic Therapy (with multilayer bandages) were included
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Intensive phase of Decongestive Lymphatic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline (first completion of the Lymph-ICF-LL questionnaire)
Secondary outcomes (4)
Face and content/floor & ceiling effects of the French Lymph-ICF-LL
A self-developed questionnaire was completed by the patients with stable lower limb lymphedema with questions about the clarity of the scoring system and questions, the completeness and redundancy of the questions of the Lymph-ICF-LL. Frequency of the minimum and maximum score was reported to evaluate floor (frequency of score 0 on the total score and subdomain scores of the Lymph-ICF-LL questionnaire) and ceiling (frequency of score 100 on the total score and subdomain scores of the Lymph-ICF-LL questionnaire) effects, respectively.
Measured: Baseline
Construct validity of the Lymph-ICF-LL
Hypothesis about which domains of the lymph-ICF-LL would be highly correlated with certain domains of the short form health survey with 36 items (SF-36) were formulated to assess convergent validity. To evaluate discriminant validity hypothesis were formulated on which domains of the lymph-ICF-LL would have a weak correlation with certain domains of the SF-36. The SF-36 was completed together with the first completion of the Lymph-ICF-LL by patients with stable lower limb lymphedema. For both the SF-36 and Lymph-ICF-LL questionnaires scores varied between 0 and 100. However, for the SF-36 a scores closer to zero reflect a worse quality of life, while for the Lymph-ICF-LL scores closer to zero reflect a better lymphedema-specific quality life.
Measured: Baseline
Internal responsiveness of the Lymph-ICF-LL
Internal responsiveness evaluates the ability of the questionnaire to have different results over a particular timeframe. For this purpose two groups of patients were included: one group where a change in lymphedema-specific quality of life can be expected (patients receiving intensive treatment) and one group where no change in lymphedema-specific quality of life is expected (patients with stable lower limb lymphedema). The Lymph-ICF-LL had to be completed at two time points (see Time Frame). A score closer to zero reflects a better lymphedema-specific quality of life and a score closer 100 reflects a worse lymphedema-specific quality of life.
Measured: 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
= extent to which the change on the Lymph-ICF-LL is related to the change on a reference measure of a person's health status over a certain time period. 2 groups of patients are included: 1 group in which a change in lymphedema-specific quality of life is expected (patients receiving intensive treatment) and 1 group in which no change in lymphedema-specific quality of life is expected (patient with stable lower limb lymphedema). The Lymph-ICF-LL is completed at 2 time points (see Time Frame). Additionally, the global perceived effect scale (GPE) was completed at the second time point in which patients have to evaluate on a 7-point Likert scale their current health status in comparison with an earlier defined timepoint. 1=completely recovered, 2=much better, 3=a little better, 4=unchanged, 5=a little worse, 6=much worse, 7=worse than ever. Patients were divided in groups. Scores 1,2= positive responder, scores 3,4,5= non-responder, scores 6,7= negative responder
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start10 Apr 2025
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphedema Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075549
- Sponsor's protocol ID
- S67308
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available on reasonable request.
Publications
Heroes AK, Fourgeaud C, Fourneau I, De Vrieze T, Frippiat J, Deltombe T, Thomis S, Abba S, Vignes S, Devoogdt N. Cross-cultural validation and responsiveness of the French version of the lymphedema functioning, disability and health questionnaire for lower limb lymphedema (Lymph-ICF-LL). Disabil Rehabil. 2026 Jul 25:1-20. doi: 10.1080/09638288.2026.2704565. Online ahead of print.
PubMed 42500949
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Validation of the French Version of the Lymphedema Functioning, Disability and Health Questionnaire for Lower Limb Lymphedema (Lymph-ICF-LL) and Responsiveness of the Dutch Version of the Lymph-ICF-LL
- ClinicalTrials.gov ID
- NCT07075549
- Acronym / sponsor ID
- S67308
- Conditions
- Lymphedema Lower Extremity
- Keywords
- Reliability, Validity, Responsiveness, Quality of Life, Questionnaire, Lymphedema, Lower Limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire UCLouvain Namur
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 20 Jul 2025 (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.
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:
- The reliability of the French Lymph-ICF-LL
- The validity of the French Lymph-ICF-LL
- The responsiveness of the original Dutch Lymph-ICF-LL
Participants are asked to complete questionnaires (Lymph-ICF-LL, Short Form-36, Global Perceived Effect Scale, questionnaire about the face and content validity) at two time points.
Detailed description
- For reliability of the French Lymph-ICF-LL questionnaire: Native French speaking patients with stable lower limb lymphedema (LLL) (= in the maintenance phase of the treatment and no intensive multicomponent bandaging is required) are asked to complete the Lymph-ICF-LL questionnaire twice with an interval of 1-2 days in between. For the test-retest reliability following outcomes are calculated: Intraclass Correlation Coefficient(2,1), standard error of measurement and the smallest real difference. For internal consistency the Cronbach's alpha is calculated for the first completion of the questionnaire.
- For the validity of the French Lymph-ICF-LL questionnaire, the construct validity, face and content validity are determined. 2.1: For construct validity (=convergent and divergent validity), patients with stable lower limb lymphedema are asked to additionally complete the 36-item Short-Form Health survey (=health-related quality of life questionnaire) together with the first completion of the Lymph-ICF-LL questionnaire. For convergent validity, hypotheses are formulated about significant correlations between domains of the 36-item Short-Form Health survey (=SF-36) and domains of the Lymph-ICF-LL questionnaire which are expected to evaluate a similar construct: 'Physical functioning' of SF-36 and 'general tasks/household', 'mobility', 'life domains/social life' of the Lymph-ICF-LL; 'Role limitations due to physical health problems' of SF-36 and 'General tasks/household' of Lymph-ICF-LL; 'Bodily pain' of SF-36 and 'Physical function' of Lymph-ICF-LL; 'Social functioning' of SF-36 and 'Life domains/ social life' of Lymph-ICF-LL; 'Role limitations due to personal or emotional problems' of SF-36 and 'Mental function' of Lymph-ICF-LL; 'Mental health' of SF-36 and 'Mental function' of Lymph-ICF-LL. For divergent validity, hypotheses are formulated about weak or non-significant correlations between domains of the SF-36 and Lymph-ICF-LL: 'Physical functioning' of SF-36 and 'Mental function' of Lymph-ICF-LL; 'Role limitations due to personal or emotional problems' of SF-36 and 'Physical function' Lymph-ICF-LL; 'Mental health' of SF-36 and 'General tasks/household', 'Mobility', 'Life domains/social life' of Lymph-ICF-LL. These hypotheses were also used in previous published research of the validation of the original Dutch Lymph-ICF-LL questionnaire. Spearman rank correlation coefficients were calculated for this purpose.A correlation coefficient below .25 represent no to a little relationship, a value between .25 and .50 indicates a low to fair relationship, a value between .50 and .75 is interpreted as a moderate to good relationship and a value above or equal to .75 as a strong relationship. 2.2 For face and content validity, patients with stable LLL are asked to complete an additional questionnaire about clarity and completeness of the Lymph-ICF-LL questionnaire: "Was each question of the Lymph-ICF-LL understandable? (yes/no)", "Was the scoring system clear? (yes/no)", "Were all complaints related to your lymphedema mentioned in the questionnaire? (yes/no)" and "Where there any questions of which you thought they were not relevant for lymphedema? (yes/no)". If patients answered 'no', they could clarify their answer in an open field.
- For the responsiveness of the French and Dutch Lymph-ICF-LL, internal and external responsiveness is evaluated in patients with stable LLL and in patients who are treated in the intensive phase with multicomponent bandages. For internal responsiveness, patients with stable LLL have to complete the Lymph-ICF-LL questionnaire twice with an interval of 2 months. Patients treated in the intensive phase have to complete the questionnaire at the start of the intensive phase and 1 month after the end of the intensive phase. The Wilcoxon signed rank test is determined to evaluate if there is a significant difference between the total and subdomain scores of two completions in patients in the intensive phase and not in patients with LLL. For the external responsiveness, all patients are asked to complete the Global Perceived effect scale (GPE) together with the second completion of the Lymph-ICF-LL questionnaire. In this GPE questionnaire patient are asked to rate their perceived change in lymphedema-specific quality of life in general and concerning the subdomains of the Lymph-ICF-LL on a 7-point Likert-scale: 1=completely recovered, 2=much better, 3= a little better, 4= unchanged, 5= a little worse, 6= much worse, 7= worse than ever. Patients who give score 1 and 2 are labeled as responders, with score 3-5 as non-responders and with scere 6-7 as negative responders. The Wilcoxon signed rank test was determined between the total and subdomain scores in the positive, negative and non responder groups. Additionally spearman rank correlations coefficients are calculated between the change in total and subdomain scores and the GPE-score. The minimal clinically important difference are calculated with the anchor-based method: descriptive statistics of the change in total and subdomain scores of the Lymph-ICF-LL are determined in patients who indicated on the GPE that the lymphedema-specific quality of life was much improved or much worsened.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Native French speaking patients with stable lower limb lymphedema in the maintenance phase | – | Other: Maintenance phase of Decongestive Lymphatic TherapyNative 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 |
| Native French speaking patients with lower limb lymphedema which are treated in the intensive phase | – | Other: Intensive phase of Decongestive Lymphatic TherapyNative 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 |
| Native Dutch speaking patients with stable lower limb lymphedema in the maintenance phase | – | Other: Maintenance phase of Decongestive Lymphatic TherapyNative Dutch speaking patients with stable lower limb lymphedema in the maintenance phase were included for the responsiveness of the Dutch Lymph-ICF-LL |
| Native Dutch speaking patients with lower limb lymphedema which are treated in the intensive phase | – | Other: Intensive phase of Decongestive Lymphatic TherapyNative 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Maintenance phase of Decongestive Lymphatic TherapyPatients with lower limb lymphedema in the maintenance phase of decongestive lymphatic therapy (with compression garments) were included | Other | 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 TherapyPatients with lower limb lymphedema who are treated in the intensive phase of Decongestive Lymphatic Therapy (with multilayer bandages) were included | Other | 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 |
Primary outcome
Reliability of the French Lymph-ICF-LL questionnaire (test-retest)
Time frame: Baseline and 1-2 days later
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.
Reliability of the French Lymph-ICF-LL questionnaire (standard error of measurement)
Time frame: Baseline and 1-2 days later
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.
Reliability of the French Lymph-ICF-LL questionnaire (smallest real difference)
Time frame: Baseline and 1-2 days later
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.
Reliability of the French Lymph-ICF-LL questionnaire
Time frame: Baseline (first completion of the 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
4 secondary outcomes
Face and content/floor & ceiling effects of the French Lymph-ICF-LL
Time frame: Baseline
Construct validity of the Lymph-ICF-LL
Time frame: Baseline
Internal responsiveness of the Lymph-ICF-LL
Time frame: 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
Time frame: 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)
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 19 Nov 2025.
- Derived from this study: PubMed 42500949Heroes AK, Fourgeaud C, Fourneau I, De Vrieze T, Frippiat J, Deltombe T, Thomis S, Abba S, Vignes S, Devoogdt N. Cross-cultural validation and responsiveness of the French version of the lymphedema functioning, disability and health questionnaire for lower limb lymphedema (Lymph-ICF-LL). Disabil Rehabil. 2026 Jul 25:1-20. doi: 10.1080/09638288.2026.2704565. Online ahead of print.
- Individual participant dataSharing planned: Undecided. Data will be made available on reasonable request.
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Chronic Edema, Lymphedema
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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema Lower Extremity, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 2 countries.
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 9 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 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, France. 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?
Reliability of the French Lymph-ICF-LL questionnaire (test-retest) (time frame: Baseline and 1-2 days later). The study lists 4 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 NCT07075549, which also lists 1 linked publication.
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 19 Nov 2025.