This is a prospective, observational, non-interventional, international, multi-center, mixed methods study that will involve the integration of quantitative and qualitative data in patients with MF/SS treated with Poteligeo.
The PROSPER study aims to collect information about the experiences of patients with MF/SS receiving Poteligeo and of their caregivers in real-world clinical practice. The objective of this study is to generate patient-level data to provide insights into real world clinical practice and an understanding of treatment decisions, as well as to collect patient reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience and burden, to demonstrate the full impact of treatment and the relevant patient experience in real-world clinical practice. The study will be conducted 6 countries, including North America, United Arab Emirates and countries in Europe, at 19 sites known to treat and follow-up patients with MF/SS. Patients will be followed for up to 50 weeks from study enrollment.
Study Type
OBSERVATIONAL
Enrollment
73
Poteligeo treatment will be used as prescribed by the Investigator in accordance with the terms of the reimbursed indication within the relevant country. The assignment of the patient to a particular therapeutic strategy falls within current practice and the prescription of Poteligeo is clearly separated from the decision to include the patient in the study.
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
To describe the patient-reported change in key signs and symptoms of disease following initiation of treatment with Poteligeo.
Patients will complete a symptom diary at regular intervals throughout the study to record symptoms including skin pain, skin itch, skin flaking, skin redness, difficulty regulating body temperature and sleep problems.
Time frame: Weekly for first 16 weeks, then every 4 weeks until Week 48, at treatment discontinuation and 8 and 16 weeks after treatment discontinuation.
To describe the patient-reported change in fatigue following initiation of treatment with Poteligeo.
Patients will complete PRO questionnaire BFI to assess changes in fatigue
Time frame: Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation.
To describe the patient-reported change in health-related QoL following initiation of treatment with Poteligeo.
Patients will complete PRO questionnaire CTCL-QoL at regular time points throughout the study to assess any changes in quality of life.
Time frame: Every 12 weeks from first dose visit to treatment discontinuation and then 8 and 16 weeks after treatment discontinuation.
To assess change in the HRQoL of the patient's main caregiver
The patient's main caregiver will be invited to complete the CareGiver Oncology Quality of Life questionnaire (CarGOQoL)
Time frame: First dose visit, at week 12 after the first Poteligeo® administration, and within 4 weeks of treatment discontinuation.
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Colombia University Medical Center
New York, New York, United States
Inova Dwight and Martha Schar Cancer Institute
Fairfax, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona
Ancona, Italy
IRCCS A.O.U. Policlinico S. Orsola - Malpighi
Bologna, Italy
Azienda Ospedaliero- Universitaria Careggi
Florence, Italy
Ematologia Policlinico di Milano
Milan, Italy
IFO-San Gallicano IRCCS
Rome, Italy
...and 9 more locations