Psychometric Properties of a Lymphedema-specific Quality of Life Questionnaire in Lower Limb Lymp… (NCT07075549) | Clinical Trial Compass
CompletedNot Applicable
Psychometric Properties of a Lymphedema-specific Quality of Life Questionnaire in Lower Limb Lymphedema
Belgium, France451 participantsStarted 2025-04-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reliability of the French Lymph-ICF-LL questionnaire (test-retest)
Timeframe: Baseline and 1-2 days later
2
Reliability of the French Lymph-ICF-LL questionnaire (standard error of measurement)
Timeframe: Baseline and 1-2 days later
3
Reliability of the French Lymph-ICF-LL questionnaire (smallest real difference)
Timeframe: Baseline and 1-2 days later
4
Reliability of the French Lymph-ICF-LL questionnaire
Timeframe: Baseline (first completion of the Lymph-ICF-LL questionnaire)