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

Centre Leon Berard43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Aged

Interventions

Individualized physical activity programOTHER

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 65 and over, * With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML), * Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination, * Followed-up in one of the investigating centers, * Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie, * Having a ECOG \< 3, * With a life expectancy \> 6 months, * Whose ability to engage in physical activity has been certified by a medical certificate issued by the investigator physician, * Available and willing to participate in the study for the duration of the intervention and follow-up, * Able to understand, read and write French, * Affiliated with a social security scheme, * Having dated and signed an informed consent. Exclusion Criteria: * Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years), * Treated by immunotherapy alone, * Participating in concurrent physical activity studies, * Deprived of their liberty by court or administrative decision.

Outcomes

Primary Outcomes

Compliance rate of the physical activity sessions

Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions

Time frame: 6 months

Compliance rate of the phone calls

Ratio of the number of phone calls performed / number of scheduled calls

Time frame: 6 months

Compliance rate of the activity tracker

Ratio of the number of days wearing the activity tracker / number of days of the program

Time frame: 6 months

Secondary Outcomes

Acceptability of the intervention

Ratio of number of patients included / number of eligible patients

Time frame: At inclusion

Safety of the intervention

Number, type and timing of program-related adverse events

Time frame: 6 months

Adherence of the intervention

Ratio of the number of patients still in the program / number of patients included in the study

Time frame: 3 months and 6 months

Impact of the program on autonomy for activities of daily living

Activities of Daily Living questionnaire (ADL) - scale from 0 to 6, 0=autonomy; 6 = no autonomy