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

NCT06299540 | Recruiting

• 1 other identifier: 54179060CLL4033
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Outcome Measures

Primary Outcomes (1)

• 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

  The FACT-G consists of 27 questions grouped in 4 dimensions: physical well-being (PWB; 7 items), social/family well-being (SWB; 7 items), emotional well-being (EWB; 6 items), and functional well-being (FWB; 7 items). Each item is given a weighted score of 0 to 4 and the score of each dimension are obtained by addition of the weighted scores of each item corresponding to the dimension. Total FACT-G score is the summation of 4 subscale scores and ranges from 0-108. Higher scores for the scales and subscales indicate better HRQoL.

  Baseline and Month 4.5

Secondary Outcomes (32)

• 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

  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

  Month 4.5 and Month 6.5

• Change from Month 6.5 in HRQoL by Using FACT-Leu Total Score at Month 12

  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

  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

  Month 4.5 and Month 6.5

Study Arms (2)

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).

Behavioral: Individual Physical Activity Intervention (IPAI); Drug: Ibrutinib

Group 2: Standard of Care

Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.

Drug: Ibrutinib

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.

Group 1: Individual Physical Activity Intervention

Ibrutinib DRUG

No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.

Group 1: Individual Physical Activity Intervention; Group 2: Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include participants aged at least 18 years of age with chronic lymphocytic leukemia (CLL).

You may qualify if:

• 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

You may not qualify if:

• Pregnant participants or planning to become pregnant while enrolled in this study
• Participants with inability or deemed unsafe to practice physical activity
• Participants who are currently involved in an interventional study
• Participants with probable difficulties in using the digital tool autonomously

Sponsors & Collaborators

• Janssen Cilag S.A.S.: lead

Study Sites (1)

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

ibrutinib

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Cilag S.A.S., France Clinical Trial

  Janssen Cilag S.A.S.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: May 27, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 29, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)