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

Sponsor
Janssen Cilag S.A.S.
Study ID
NCT06299540
Status
Recruiting
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Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Individual Physical Activity Intervention (IPAI) — BEHAVIORAL
    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.
  • Ibrutinib — DRUG
    No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.

Study Details

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).

Key Dates

Start date
May 27, 2024
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Oct 29, 2027

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Group 1: Individual Physical Activity Intervention
    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).
  • Arm: Group 2: Standard of Care
    Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.

Primary Outcome 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 [ Time Frame: Baseline and Month 4.5 ]

Central Contacts

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