PROVIDENCE: 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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06125795

Collaborator

(none)

132

Enrollment

Locations

17.8

Anticipated Duration (Months)

26.4

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia

Study Design

Study Type:

Observational

Anticipated Enrollment :

132 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 6, 2023

Anticipated Primary Completion Date :

Apr 30, 2025

Anticipated Study Completion Date :

Apr 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Chronic Lymphocytic Leukemia (CLL) Participants Participants will receive oral treatments for CLL in accordance with approved local label.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hospital Universitario Virgen de las Nieves /ID# 258280	Granada	Spain	18014
2	Hospital General Universitario Gregorio Maranon /ID# 258273	Madrid	Spain	28007
3	Hospital Universitario Fundacion Jimenez Diaz /ID# 258269	Madrid	Spain	28040
4	Hospital Universitario La Paz /ID# 258270	Madrid	Spain	28046
5	Hospital Universitario Virgen Macarena /ID# 258279	Sevilla	Spain	41009