Responsiveness of the Dutch Lymph-ICF-LL Questionnaire and Cross-cultural Validation of French Version in Patients With Lower Limb Lymphedema
- Conditions
- Lymphedema Lower Extremity
- Registration Number
- NCT07075549
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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. The reliability of the French Lymph-ICF-LL
2. The validity of the French Lymph-ICF-LL
3. 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
- 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 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 reliabilty/validity/responsiveness); patients receive intensive treatment in the hospital (for the responsiveness)
- Given informed consent to participate
- >18 years old
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reliability of the French Lymph-ICF-LL Baseline and 1-2 days later Following aspects were assessed to investigate the reliability of the French Lymph-ICF-LL:
1. Internal Consistency
2. Test-retest Reliability
3. Standard error of measurement (SEM)
4. Smallest Real Difference (SRD) Patients completed the Lymph-ICF-LL two times with an interval of 1-2 days
- Secondary Outcome Measures
Name Time Method Construct validity of the Lymph-ICF-LL Baseline Hypothesis about which domains of the lymph-ICF-LL would be highly correlated with certain domains of the SF-36 wereformulated 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 (short form health suvery with 36 items) was completed together with the first completion of the Lymph-ICF-LL by 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) External responsiveness is the extent to which the change on the questionnaire being evaluated is related to the change on a reference measure of a person's health status over a certain time period. For this purpose two groups of patients were included: one group where a change in lymphedema-specific quality of life was expected (patients receiving intensive treatment) and one group where no change in lymphedema-specific quality of life were expected (patient with stable lower limb lymphedema in the maintenance phase). The Lymph-ICF-LL was completed at two 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. Depending on the score on the GPE, patients were divided in a responder and non-responder group.
Face and content/floor & ceiling effects of the French Lymph-ICF-LL Baseline 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 and ceiling effects, respectively.
Internal responsiveness of the Lymph-ICF-LL At start of the intensive phase and 1 month after the end of the intensive phase (patienst receiving intensive treatment) or at baseline and 2 months later (patients with stable lower limb lymphedema) 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)
Trial Locations
- Locations (3)
UZ Leuven and KU Leuven
🇧🇪Leuven, Belgium
CHU UCL Namur site Godinne
🇧🇪Yvoir, Belgium
Hôpital Cognacq-Jay
🇫🇷Paris, France
UZ Leuven and KU Leuven🇧🇪Leuven, Belgium