Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia (QOLIBRI)

Janssen (J&J Innovative Medicine)

Status: Enrolling

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Behavioral: Individual Physical Activity Intervention (IPAI); Drug: Ibrutinib

Study type: Observational

Funder types: Industry

Identifiers

NCT06299540

54179060CLL4033 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the impact of an individual physical activity intervention (IPAI) on health-related quality of life (HRQoL) in participants with first line or relapsed chronic lymphocytic leukemia (CLL) initiating ibrutinib in a routine clinical practice setting. HRQoL will be measured using functional assessment of cancer therapy - general scale (FACT-G).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants newly treated with ibrutinib for first line or relapsed CLL (treatment is being initiated or has been initiated within the last 8 days as a maximum)
• Participants agreed to follow the individual physical activity intervention (IPAI)
• Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet
• Participants with Internet access at home and email address
• Participants agreed to wear a connected watch 24 hours a day for all the duration of the study

Exclusion criteria

• Pregnant participants or planning to become pregnant while enrolled in this study
• Participants with inability or deemed unsafe to practice physical activity
• Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit
• Participants who are currently involved in an interventional study
• Participants with probable difficulties in using the digital tool autonomously

Trial design

180 participants in 2 patient groups

Group 1: Individual Physical Activity Intervention

Description:

Participants with chronic lymphocytic leukemia (CLL) will be invited to perform physical activity according to a predefined intervention program. This program includes walking and weekly remote adapted physical activity sessions (2 sessions per week, the duration and difficulty of which will be adapted by the adapted physical activity \[APA\] trainer according to the Participant's abilities).

Treatment:

Drug: Ibrutinib

Behavioral: Individual Physical Activity Intervention (IPAI)

Group 2: Standard of Care

Description:

Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.

Treatment:

Drug: Ibrutinib