Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Chronic, B-Cell | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Individual Physical Activity Intervention (IPAI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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).
- interventionNames
- Behavioral: Individual Physical Activity Intervention (IPAI)
- Drug: Ibrutinib
- label
- Group 2: Standard of Care
- description
- Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.
- interventionNames
- Drug: Ibrutinib
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available