RECRUITINGOBSERVATIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

BEHAVIORAL

Individual 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.

DRUG

Ibrutinib

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