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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Lymphocytic Leukemia Behavior Chronic Disease Disease Attributes Health Behavior Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Preference Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HUA - Txagorritxu /ID# 258263, Vitoria-Gasteiz, Alava, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Acronym: PROVIDENCE

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Nov 9, 2023
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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