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Recruiting NCT06299540

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

— Observational Leukemia, Lymphocytic, Chronic, B-Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individual Physical Activity Intervention (IPAI), Ibrutinib.
Who it may be relevant to
Registry conditions: Leukemia, Lymphocytic, Chronic, B-Cell. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Change from Baseline in HRQoL by Using Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) Total Score at Month 4.5, Month 6.5 and Month 12 [Time frame: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change from Month 4.5 in HRQoL by Using FACT-Leu Total Score at Month 6.5 [Time frame: Month 4.5 and Month 6.5]
  • Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12 [Time frame: Month 6.5 and Month 12]
  • Change from Baseline in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 4.5, Month 6.5, and Month 12 [Time frame: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change from Month 4.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 6.5 [Time frame: Month 4.5 and Month 6.5]
  • Change from Month 6.5 in HRQoL by Using Trial Outcome Index (TOI) Total Score at Month 12 [Time frame: Month 6.5 and Month 12]
  • Change from Baseline in HRQoL by Using FACT-G Scale at Month 6.5 and Month 12 [Time frame: Baseline, Month 6.5, and Month 12]
  • Change from Month 4.5 in HRQoL by Using FACT-G Scale at Month 6.5 [Time frame: Month 4.5 and Month 6.5]
  • Change from Month 6.5 in HRQoL by Using FACT-G Scale at Month 12 [Time frame: Month 6.5 and Month 12]
  • Percentage of Participants Achieving a Greater Than or Equal to (>=) 5-Point Improvement in the FACT-G Total Score at Months 4.5, 6.5, and 12 as Compared to Baseline [Time frame: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score at Month 4.5, Month 6.5, and Month 12 [Time frame: Baseline, Month 4.5, Month 6.5, and Month 12]
  • Change From Baseline in Total Sleep Time Using Connected Watch [Time frame: Baseline, Month 4.5, Month 6.5, and Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Institut Universitaire du Cancer Toulouse Oncopole — Toulouse

Identifiers

NCT: NCT06299540 · 54179060CLL4033 · 54179060CLL4033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗