NCT04052126

An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies

An Interventional Prospective Study to Test the Feasibility of an Individualized Physical Activity Program in Patients Over 65 Years of Age With Hematologic Malignancies: the OCAPI Project.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed. OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG \<3, with no contraindications to PA and no history or coexistence of other primary cancer. Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.

Conditions

• Aged
• Aged, 80 and Over
• Leukemia, Myeloid, Acute
• Lymphoma, Non-Hodgkin
• Exercise
• Quality of Life
• Fatigue

Interventions

Type	Name	Description
OTHER	Individualized physical activity program	Participants who agreed to participate in the study will participate in an individualized 6-month physical activity (PA) program, consisting of 3 periods: initiation (1st month), transition (2nd-3rd months) and autonomy (4th-6th months). It is based on 4 PA modalities: The supervised PA session in a sterile room or at home once a week during the initiation and transition phases (20-45 min, low-to-moderate intensity, walking, muscle strengthening, balance and flexibility exercises). The unsupervised PA session in a sterile room or at home once a week during the transition phase and twice a week during the autonomy phase (same as supervised session). Follow-up by telephone once a month during the autonomy phase (30 min, support to PA). Continuously wearing an activity tracker throughout the entire program (promotion of walking). Activities are planned over a period of 6 months to achieve an intervention that meets the key principles of progression, specificity and empowerment.

Timeline

• Start date: 2019-11-28
• Primary completion: 2022-11-23
• Completion: 2023-05-30
• First posted: 2019-08-09
• Last updated: 2023-08-30

Locations

1 site across 1 country: France