A Study to Assess Change in Functioning and Health Related Quality of Life in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Treatments in Routine Clinical Practice in Spain

Non-interventional Prospective Descriptive Study to Assess the Impact on Patient´s Well-being of Fixed-time Duration (FTD) and Continuous Oral Regimens for Newly Diagnosed and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice in Spain

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06125795

Acronym

PROVIDENCE

Enrollment

146

Registered

2023-11-09

Start date

2023-11-06

Completion date

2026-07-01

Last updated

2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, Bruton Tyrosine Kinase Inhibitor, Patient-Reported Outcomes Measure, Patient-Reported Experience Measure, Venetoclax, Venclexta, Venclyxto, ABT-199, Patient Preferences, Cancer, PROVIDENCE

Brief summary

Chronic lymphocytic leukemia (CLL) is the most common leukemia in the Western world. Since in most cases CLL remains an incurable disease, the goals of therapy are to improve quality of life and to prolong survival. This study will evaluate the participant's related outcomes and experience of CLL in adult participants who are treated in the Spain. Study participants will receive oral treatments for CLL as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed various treatments will be enrolled. Around 132 participants will be enrolled in the study in sites in Spain. Participants will receive oral treatments for CLL according to the approved local label. The overall study duration will be 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have documented chronic lymphocytic leukemia (CLL) according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. * Under oral treatment for CLL, either first-line or relapsed/refractory (R/R) therapy. * Treatment for CLL started 9 months (+/- 4 weeks) before inclusion for first-line therapy or 21 months (+/- 4 weeks) before inclusion for R/R, under authorized conditions. * In the opinion of the investigator, cognitive ability to understand and answer the questionnaires specified in the study protocol. * Able to comply with the study protocol in the investigator's judgment.

Exclusion criteria

* Currently receiving any chemotherapy or chemoimmunotherapy. * Transformation of CLL to aggressive non-Hodgkin's lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukaemia). * Currently participating in interventional research (not including non-interventional study, post-marketing observational study, or registry participation). * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study.

Design outcomes

Primary

Measure	Time frame	Description
Change in Participant Functioning Measured Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) with the EORTC Chronic Lymphocytic Leukemia 17 (EORTC-CLL17) Supplement	Up to 27 Months	The EORTC-CLL17 is a specific questionnaire that supplements the EORTC QLQ-C30 for participants with CLL. EORTC-CLL17 comprises 17 items divided into three subscales: symptom burden, physical condition/fatigue, and worries/fears about the health and functioning. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. A high score represents a high level of symptomology high level of physical condition/fatigue, and a high level of worries/fears about the health and functioning. EORTC QLQ-C30 is a questionnaire to assess the quality of life (QoL) of cancer participants. It is composed of five functional scales, three symptom scales, a global health status/QoL scale, and six single items. A high score represents high level of functioning, or QoL, but a high level of symptomology/problems.
Change in Participant Health-related Quality of Life (HRQoL)Measured Using the EORTC QLQ-C30 with the EORTC-CLL17 Supplement	Up to 27 Months	The EORTC-CLL17 is a specific questionnaire that supplements the EORTC QLQ-C30 for participants with CLL. EORTC-CLL17 comprises 17 items divided into three subscales: symptom burden, physical condition/fatigue, and worries/fears about the health and functioning. The scores of each subscale are calculated based on the EORTC's protocol and then transformed to a 0 to 100 scale. A high score represents a high level of symptomology high level of physical condition/fatigue, and a high level of worries/fears about the health and functioning. EORTC QLQ-C30 is a questionnaire to assess the QoL of cancer participants. It is composed of five functional scales, three symptom scales, a global health status/QoL scale, and six single items. A high score represents a high level of functioning, or QoL, but a high level of symptomology/problems.

Countries

Spain

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results