Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06066229
Other study ID # APHP 220838
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 10, 2023
Est. completion date March 31, 2024

Study information

Verified date September 2023
Source Assistance Publique - Hôpitaux de Paris
Contact WEISENBURGER Gaëlle, MD
Phone 01 40 25 69 13
Email gaelle.weisenburger@aphp.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Lung transplantation (LT) is the treatment for end-stage respiratory failure, for severe cases after thorough clinical and paraclinical evaluation. Patients often face a lengthy journey before being placed on the transplant list, and post-transplant care can seem to be demanding. Patient-Important Outcomes (PIO), have emerged across various medical fields, aiming to prioritize the patient's perspective in medical research. This approach seeks to align clinical outcomes with those important to patients, such as pain, mobility, autonomy, and quality of life. The focus on patient-centered research is crucial not only in medical care but also in clinical research. While several medical fields have embraced this approach, including diabetology, rheumatology, urology, and more, the field of lung transplantation has yet to fully explore the importance of PIO. LT addresses diverse underlying conditions (e.g., cystic fibrosis, pulmonary fibrosis, emphysema, pulmonary hypertension), impacting potentially different patient populations. However, the transplantation process standardizes certain aspects, such as follow-up obligations, treatments, side effects, and complications, which can affect patient quality of life. A systematic literature review of LT studies published in 2019 found that only 11 out of 51 studies evaluated PIOs beyond mortality. This highlights the need to assess interventions in this field based on criteria important to patients. Besides the impact on the patient, the influence on their close family members and caregivers is significant. The transition from severe respiratory disease to near-normal respiratory function can lead to a reevaluation of the caregiver's role and responsibilities. Currently, researchers and clinicians in transplantation focus more on Patient-Reported Outcomes (PRO) than on outcomes important to patients. To bridge this gap, this study aims to identify PIOs from the perspectives of clinicians, transplant recipients, and their families. The Delphi method is chosen to gather anonymous expert opinions and reach a consensus on defining PIOs in the context of lung transplantation. Ultimately, this research aims to create a "core outcome set" necessary for LT research, incorporating dimensions beyond mortality, which is the traditional focus in assessing transplant outcomes.


Description:

Lung transplantation (LT) is an exceptional treatment for severe patients. It is a lengthy process, and its outcomes may seem burdensome. LT is the subject of thriving research: a search on ClinicalTrials with the terms 'Lung Transplant' retrieves 85 ongoing studies. Outcome measures (OM) are used to assess the impact of an intervention during a prognostic study. They must be carefully chosen, relevant, reproducible, and validated. It is challenging for researchers to find a balance between these OM, which should be objective, reliable, easily evaluable, and OM that are important to the patient (patient-important outcomes - PIO) and integrate into their daily lives. The emergence of PIO has occurred in many fields (Dinglas Thorax 2018, Partridge Lancet 2004). They 'reflect what the patient feels, their functional state, or under what conditions they survive' (Wittes, Stat Med 1989) and cover various domains (pain, mobility, autonomy, quality of life, etc.). The role of PIO in LT has never been evaluated. We conducted a systematic review aiming to describe the role of PIO in LT research, published in 2019 (Weisenburger et al., Respir Med Res 2022). At least one PIO was used in 26 out of the 51 included studies, with only 11 evaluating a PIO other than mortality. Some transplant physicians are well aware of this gap (Lamas, NEJM 2018). Placing the patient's concerns at the center is considered an essential objective in patient care and clinical research, including in LT. PIO could encompass mortality and patient-reported OM (PROMS), but there could also be OM that we, clinicians and researchers, have not considered, which could be crucial for patients. Gathering the opinions of lung transplant patients, their families, and healthcare providers (physicians and paramedics) involved in LT will help define a set of PIO in LT. This work proposes an original approach to identify PIO in LT in order to define a 'core outcome set,' a recommended set of outcome measures to be used. The development of a 'core outcome set' incorporating PIO can only be achieved through the participation of patients (Needham, AJRCCM 2017) in collaboration with clinicians and researchers. A Delphi-like methodology allows for the establishment of such criteria. Involving patients and their families places their concerns at the center of research that affects them. The two participating LT centers complement each other in terms of patient recruitment (preferentially patients with chronic obstructive bronchopneumopathy or fibrosing pneumopathies at Bichat Hospital; preferentially younger patients with cystic fibrosis at Foch Hospital). The development of a 'core outcome set' will guide the LT research community towards the selection of relevant OM for patients and healthcare providers. Such work would also involve patients and their families, which is important in the field of LT research. Our results could be used to provide recommendations for future LT research and help standardize prognostic evaluation measures. The methods for assessing the performance of LT centers could be reviewed and not solely rely on the isolated measurement of mortality." Practical implementation: A Delphi survey will be conducted. This method aims to gather anonymous opinions from one or more groups of experts in order to reach a consensus on subjects with uncertain definitions (Linstone et al. 2002; Fink et al. Am J Public Health 1984). This methodology has been used, among others, to identify important evaluation domains for survivors of acute respiratory distress syndrome and their families (Dinglas, Thorax 2018). Formation of four panels: - Patients followed in one of the two participating centers (Bichat Hospital, Paris; Foch Hospital, Suresnes). - Relatives (spouses, partners, or, if not available, first-degree relatives) of patients in one of the participating centers. - Clinician doctors and researchers from LT centers, belonging to the lung transplantation group of the French Language Pneumology Society or the francophone network of investigators. - Paramedical caregivers (nurses, advanced practice nurses, transplantation coordination nurses, psychologists, physiotherapists, etc.) working in one of the French or identified French-speaking centers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date March 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Lung transplant patients followed at Bichat Hospital (Paris) or Foch Hospital (Suresnes). - Close relatives of lung transplant patients (spouse; partner; first-degree parent) followed at Bichat Hospital (Paris) or Foch Hospital (Suresnes). - Physicians from lung transplant centers in France, or French-speaking experts identified in the professional network of investigators. - Paramedical staff (state certified nurses, psychologists, physiotherapists, etc.) from the same French center or French-speaking centers whose primary focus is on caring for lung transplant patients. Exclusion Criteria: - Patients or close relatives under guardianship or protective supervision. - Minor patients or minor close relatives. - Patients or close relatives of recently transplanted patients (immediate post-transplant hospitalization). - Patients or close relatives of patients who have undergone a combined transplant (liver-lung, heart-lung, kidney-lung). - Non-comprehension of the French language. - Inability to use computer tools. - Refusal to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire- Delphi method
Identify important evaluation criteria for lung transplant patients by rating each criterion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type Measure Description Time frame Safety issue
Primary Identifying a set of outcome criteria defined as Patient Important Outcomes (PIO) from the perspective of physicians, paramedics, lung transplant patients, and their families Delphi method 3 weeks
Secondary Evaluate the participation within each panel and at each round of the Delphi survey. Rate of participation within each panel and at each round of the Delphi survey. 3 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT03299504 - Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation
Completed NCT00755781 - Study of Cyclosporine Inhalation Solution (CIS) in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation Phase 3
Recruiting NCT05547698 - A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation N/A
Terminated NCT03207399 - Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment Phase 4
Completed NCT03300882 - PREDICT Cytomegalovirus (CMV)
Recruiting NCT05101460 - An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
Completed NCT03150095 - Health Coaching to Improve Self-Management in Thoracic Transplant Candidates N/A
Completed NCT04420195 - Envarsus XR in Lung Transplant Phase 2
Recruiting NCT02235610 - Use of Ex Vivo Lung Perfusion (EVLP) in Reconditioning Marginal Donor Lungs for Transplantation N/A
Recruiting NCT04601818 - Planned Semi-Elective Lung Tx Study N/A
Recruiting NCT03072589 - Study to Evaluate Adenosine 2A Receptor Agonist (Regadenoson) in Patients Undergoing Lung Transplantation Phase 1
Completed NCT01963780 - International EXPAND Lung Pivotal Trial N/A
Recruiting NCT05671887 - DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies
Completed NCT03987113 - Impact of Cold Ischemia on Pulmonary Endothelial Dysfunction in Ex-vivo Pulmonary Reconditioning
Recruiting NCT02748798 - Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders Early Phase 1
Completed NCT03167528 - Contribution of Learning and Practice of Different Complementary Therapies in Pulmonary Transplant Patients N/A
Active, not recruiting NCT04244734 - Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home. N/A
Active, not recruiting NCT01365429 - Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs N/A
Recruiting NCT05055739 - Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant N/A