The EMPATHY Pilot Study

Cancer Clinical Trial

Official title:

Evaluating Patient-Reported Outcomes Monitoring in Routine Care of Patients With Chronic Myeloid Leukemia for Increasing Adherence and Clinical Response to THerapY: The EMPATHY Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04384848
• Other study ID #: 1R21CA230367-01A1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: February 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study, may significantly contribute to improve healthcare delivery in patients with Chronic Myeloid Leukemia (CML) treated with modern tyrosine kinase inhibitors (TKIs) in two ways. First, it may provide novel empirical data on the positive effects of systematically monitoring of patient-reported adverse events (AEs) in routine practice for improving symptom management and adherence to therapy. Second, it will inform the development of a large international randomized controlled trial (RCT) to test whether systematic collection of patient-reported AEs, could improve clinical response to TKI therapy.

Description:

The evolution in the understanding of the biology of Chronic Myeloid Leukemia (CML), that eventually translated into highly effective molecular targeted therapies, is unparalleled in cancer medicine. This knowledge led the development of a number of orally active molecule tyrosine kinase inhibitors (TKIs) that have dramatically improved clinical outcomes. In less than two decades, the 10-year survival probability increased from 20 to 53% with previous (IFN)-therapies to about 90% in the TKI era. Life expectancy of these patients now approaches that of the general population. While oral TKIs are now the standard of care for CML, it should be considered that therapy is lifelong and patients are requested to take medication on a daily basis. Importantly, there is convincing evidence that full adherence to therapy is a critical factor to obtain and maintain an optimal response to therapy. However, non-adherence is a major challenge in CML, since side effects induced by these drugs negatively impact on patient's quality of life (QoL), seriously undermine full adherence with treatment schedule and thereby often lead to sub-optimal clinical responses to drugs. From previous Preliminary Data we extrapolated the following evidences: Systematic monitoring of Patient-Reported Outcomes (PRO) in routine care has several advantages, such as improved symptom control, enhanced patient-physician communication, as well as patient satisfaction and wellbeing. Furthermore, it was found that Adverse Events (AEs) are the most frequent cause for non-adherence to CML therapy and that even experienced physicians tend to underestimate burden of TKIs of their patients. This mismatch might have major clinical implications in disease management, as physicians might not be able to early identify those patients who might be at heightened risk of poor adherence behavior. Given these findings, we hypothesized that systematic electronic monitoring of Patient-Reported AEs in CML routine practice may improve adherence to therapy, quality of life, and clinical response to therapy. This hypothesis will be addressed in the experiments of the following Specific Aims: 1) To develop an online platform for systematic monitoring of patient-reported AE assessment that is tailored to the unique demands of TKI therapy for CML. 2) To assess patient and physician acceptability and satisfaction with use of this platform in CML routine practice and evaluate its value in improving symptom management, quality of life, adherence to therapy as well as preliminary efficacy. We anticipate this study will provide unprecedented information on the value of systematically collecting patient-reported AEs information in CML routine care. If positive, our results will inform the development of large international randomized controlled trial (RCT) to investigate whether this experimental approach can improve depth and rates of clinical responses to TKI therapies in CML patients.

Dr. Fabio Efficace is also a Principal Investigator on this study. He is also a Professor in the Department of Medical Social Sciences at Northwestern University, Feinberg School of Medicine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 31, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;

2. Newly diagnosed chronic phase (CP)-CML Patients planned to receive one of the following TKI approved as first line treatment: imatinib, dasatinib, nilotinib or bosutinib;

3. Adult Patients (=18 years) at the time of study entry; Children under the age of 18 will be excluded from the study. The exclusion of children is justified by the following circumstances: a) The condition is relatively rare in children, as compared to adults; b) Issues of study preclude direct applicability of hypotheses and/or interventions to both adults and children.

4. Written informed consent.

5. Written informed consent from Patient's physician as a participant.

6. Newly diagnosed Chronic Phase (CP)-CML Patients who are within 4 weeks of first line TKI therapy (anyone of the TKI approved in the USA and Europe, that is: imatinib, dasatinib, nilotinib or bosutinib).

7. Ability to read/converse in English (Northwestern University and Augusta University Sites). Ability to read/converse in Italian (GIMEMA Centers).

Patient exclusion criteria will include:

1. Major cognitive deficits or psychiatric problems hampering a self-reported evaluation;

2. Having received any CML treatment - other than TKI - for more than 3 months prior to receiving current TKI therapy.

This project will focus on CML, which affect both men and women. Therefore, there are no exclusion/inclusion criteria based on sex/gender. In addition, there are no exclusion/inclusion criteria based on race and ethnicity.

Physician inclusion criteria will include:

1)Provider of clinical care for Patient who meets inclusion criteria for the study

Please note that Physician consent is requisite for the Patient to be enrolled as a participant in the study.

Exclusion Criteria:

1. Major cognitive deficits or psychiatric problems hampering a self-reported evaluation

2. Having received any CML treatment prior to therapy with imatinib, dasatinib, bosutinib or nilotinib for more than three months

Related Conditions & MeSH terms

• Cancer
• Leukemia
• Leukemia, Chronic Myeloid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Intervention

Other:
• EMPATHY Pilot
The goal of this pilot is to develop and pilot a tailored monitoring intervention targeting symptomatic, Patient-reported adverse events (AEs) in chronic myeloid leukemia (CML) Patients undergoing first-line tyrosine kinase inhibitor (TKI) therapy. The tailored monitoring intervention will draw primarily from the PRO-CTCAE Item Library, with additional items drawn from the FACIT and EORTC Item libraries as necessary. After identifying the full set of AEs to be monitored, we will load the Patient assessment and report program into tablets for electronic administration in the busy clinic setting. We will then pilot a six-month intervention aimed to monitor and manage emerging AEs, coupled with assessment of intervention feasibility, Patient acceptability and satisfaction, provider acceptability and clinical management utility, adherence to TKI therapy, and HRQoL. We expect that adherence to therapy, clinical response, and HRQoL will be enhanced by such an intervention.

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola Malpighi - UOC Ematologia - Azienda Ospedaliero-Universitaria di Bologna	Bologna
Italy	Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO - Azienda Ospedaliera G. Brotzu	Cagliari
Italy	Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - UOC Oncoematologia - Padiglione Marcora	Milano
Italy	Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - UOC Ematologia	Napoli
Italy	Azienda Ospedaliera Universitaria Maggiore della Carità di Novara - SCDU Ematologia	Novara
Italy	AUSL Reggio Emilia - Arcispedale S. Maria Nuova, IRCSS - SC Ematologia	Reggio Emilia
Italy	Azienda Ospedaliera Universitaria Policlinico Umberto I - Università degli Studi "Sapienza" - UOC Ematologia	Roma
Italy	Ospedale Sant'Eugenio	Roma
Italy	The GIMEMA Foundation (Italian Group for Adult Hematologic Diseases)	Rome
Italy	Azienda Ospedaliero-Universitario Città della Salute e della Scienza di Torino - Ospedale S. Giovanni Battista Molinette - SC Ematologia	Torino
Italy	Ospedale Mauriziano Umberto I - Torino - SCDU Ematologia	Torino
Italy	ASUI di Udine - Presidio Ospedaliero "Santa Maria della Misericordia" - Clinica Ematologica	Udine
Italy	Azienda Ospedaliera Universitario Integrata di Verona, Policlinico G.B. Rossi - UOC Ematologia	Verona
Italy	USL 6 - Ospedale San Bortolo - Vicenza	Vicenza
United States	Augusta University, Hematology and Oncology	Augusta	Georgia
United States	Northwestern University, Robert H. Lurie Comprehensive Cancer Center Comprehensive Cancer Center (RHLCCC)	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Augusta University, Fondazione GIMEMA - Franco Mandelli Onlus, National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Italy, 

References & Publications (34)

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Efficace F, Baccarani M, Breccia M, Cottone F, Alimena G, Deliliers GL, Barate C, Specchia G, Di Lorenzo R, Luciano L, Turri D, Martino B, Stagno F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Fava C, Veneri D, Sica S, Rambaldi A, Rosti G, Vignetti M, Mandelli F. Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib. Leukemia. 2013 Jul;27(7):1511-9. doi: 10.1038/leu.2013.51. Epub 2013 Feb 18. — View Citation

Efficace F, Baccarani M, Breccia M, Saussele S, Abel G, Caocci G, Guilhot F, Cocks K, Naeem A, Sprangers M, Oerlemans S, Chie W, Castagnetti F, Bombaci F, Sharf G, Cardoni A, Noens L, Pallua S, Salvucci M, Nicolatou-Galitis O, Rosti G, Mandelli F. International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24. Qual Life Res. 2014 Apr;23(3):825-36. doi: 10.1007/s11136-013-0523-5. Epub 2013 Sep 13. — View Citation

Efficace F, Baccarani M, Rosti G, Cottone F, Castagnetti F, Breccia M, Alimena G, Iurlo A, Rossi AR, Pardini S, Gherlinzoni F, Salvucci M, Tiribelli M, Vignetti M, Mandelli F. Investigating factors associated with adherence behaviour in patients with chronic myeloid leukemia: an observational patient-centered outcome study. Br J Cancer. 2012 Sep 4;107(6):904-9. doi: 10.1038/bjc.2012.348. Epub 2012 Aug 7. — View Citation

Efficace F, Cannella L. The value of quality of life assessment in chronic myeloid leukemia patients receiving tyrosine kinase inhibitors. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):170-179. doi: 10.1182/asheducation-2016.1.170. — View Citation

Efficace F, Gaidano G, Lo-Coco F. Patient-reported outcomes in hematology: is it time to focus more on them in clinical trials and hematology practice? Blood. 2017 Aug 17;130(7):859-866. doi: 10.1182/blood-2017-03-737403. Epub 2017 Jul 10. — View Citation

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	Adherence to Refills and Medications Scale (ARMS). The ARMS-7 consists of seven items evaluating adherence to taking medications and refilling prescriptions. Items are rated on a four-point Likert scale ranging between 7 and 28, with higher scores indicating lower medication adherence.	6 months
Primary	Number of Participants Adherent To Their Medication	Prescription refill data extracted from hospital pharmacy records. Prescription refill data were evaluated over 6 months. Missed refills, for reasons other than mortality or physician change of medication, were counted as non-adherence. Adherence was defined as the number of days medicine not available between each refill over the number of days between first prescription and last refill during the study period.	6 months
Secondary	Health-Related Quality of Life	Functional Assessment of Cancer Therapy-General. The possible score range of this measure is 0-128. Higher scores denote better quality of life	6 months
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue. the possible score range of this measure is 0-52. Higher scores reflect less fatigue	6 months
Secondary	Cytogenetic Response	Cytogenetic response (CyR) is defined based on the percentage of Ph pos metaphases, as evaluated by chromosome banding analysis of at least 20 marrow cell metaphases (cytogenetics). Complete CyR is when the percentage of Ph pos metaphases is 0; Partial CyR is when the percentage of Ph pos metaphases ranges from 1 to 35, Minor CyR if the percentage of Ph pos metaphases ranges from 36 to 65, minimal CyR if the percentage of Ph pos metaphases ranges from 66 to 95, No CyR if the percentage of Ph pos metaphases is higher than 95.	6 months

External Links

•   EORTC Quality of Life Group Item Library
•   FACIT Searchable Library and Custom Form Developer (Build-a-PRO)