RecruitingNCT06299540

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

Benefits of an Individual Physical Activity Intervention on Health-related Quality of Life in Patients With Chronic Lymphocytic Leukemia Receiving Ibrutinib in Real-life Practice


Sponsor

Janssen Cilag S.A.S.

Enrollment

180 participants

Start Date

May 27, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a personalized physical activity program can improve the quality of life for people with chronic lymphocytic leukemia (CLL) who are just starting a medication called ibrutinib. Participants will wear a smartwatch, use a digital tool, and follow an exercise plan tailored to them. **You may be eligible if...** - You have CLL and are starting ibrutinib for the first time or for relapsed disease (treatment started within the last 8 days) - You are willing to follow a personalized physical activity program - You have a smartphone, laptop, or tablet and access to the internet at home - You are willing to wear a connected smartwatch 24 hours a day for the whole study **You may NOT be eligible if...** - You are pregnant or planning to become pregnant - You are unable to safely exercise - You have used an experimental drug within the past 90 days - You are already enrolled in another interventional clinical study - You would have difficulty using digital tools on your own Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIndividual Physical Activity Intervention (IPAI)

No drug will be administered as a part of this study. The intervention will consist in an IPAI provided to participants for 6 months to practice physical activity in addition to their medical treatment in routine clinical practice settings. IPAI will be an adaptive program and will comprise two periods, the first period consisting in a supervised 4-month program and the second one in an unsupervised 2-month program to achieve greater autonomy.

DRUGIbrutinib

No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.


Locations(1)

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

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NCT06299540


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