RecruitingNot Applicable

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

France180 participantsStarted 2024-05-27

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline in Health-related Quality of Life (HRQoL) by Using Functional Assessment of Cancer Therapy General (FACT-G) Total Score at Month 4.5

Timeframe: Baseline and Month 4.5

Trial details

NCT IDNCT06299540

SponsorJanssen Cilag S.A.S.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-09-30

Contact for this trial

Study Contact

844-434-4210 Participate-In-This-Study1@its.jnj.com

View on ClinicalTrials.gov More Leukemia, Lymphocytic, Chronic, B-Cell trials