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

Study Overview
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Brief Summary
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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.

Official Title
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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.

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

Intervention / Treatment
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* Other: Individualized physical activity program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized physical activity program<br> | Other: Individualized physical activity program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate of the physical activity sessions | Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions | 6 months | 
| Compliance rate of the phone calls | Ratio of the number of phone calls performed / number of scheduled calls | 6 months | 
| Compliance rate of the activity tracker | Ratio of the number of days wearing the activity tracker / number of days of the program | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the intervention | Ratio of number of patients included / number of eligible patients | At inclusion | 
| Safety of the intervention | Number, type and timing of program-related adverse events | 6 months | 
| Adherence of the intervention | Ratio of the number of patients still in the program / number of patients included in the study | 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 | At inclusion, 3 months and 6 months | 
| Impact of the program on autonomy for instrumental activities of daily living | Instrumental activities of Daily Living questionnaire (IADL) - scale from 0 to 4, 0=autonomy; 4 = no autonomy | At inclusion, 3 months and 6 months | 
| Impact of the program on upper body strength | 30-s Arm Curl Test | At inclusion, 3 months and 6 months | 
| Impact of the program on lower body strength | 30-s Chair Stand Test | At inclusion, 3 months and 6 months | 
| Impact of the program on upper body flexibility | Back Scratch Test | At inclusion, 3 months and 6 months | 
| Impact of the program on lower body flexibility | Chair Sit and Reach Test | At inclusion, 3 months and 6 months | 
| Impact of the program on agility | Timed Up and Go Test | At inclusion, 3 months and 6 months | 
| Impact of the program on walking endurance | 6-min Walk Test | At inclusion, 3 months and 6 months | 
| Impact of the program on walking speed | 10-m Walk Test | At inclusion, 3 months and 6 months | 
| Impact of the program on balance | Open-eyes Unipodal Test | At inclusion, 3 months and 6 months | 
| Impact of the program on grip strength | Hand Grip Dynamometer Test | At inclusion, 3 months and 6 months | 
| Impact of the program on anthropometrics | BMI (weight and height will be combined to report BMI in kg/m^2) | At inclusion, 3 months and 6 months | 
| Impact of the program on nutrition | Mini Nutritional Assessment (MNA) - scale from 0 to 30 points; score<17=bad nutritional status ; 17 and 23.5=risk of malnutrition ; >24: adaptednutritional status | At inclusion, 3 months and 6 months | 
| Impact of the program on cognition | Montreal Cognitive Assessment (MoCA) ; scale from 0 to 30; normal if score >16 | At inclusion, 3 months and 6 months | 
| Impact of the program on depression | Geriatric Depression Scale-15 (GDS-15) ; scale from 0 to 15 ; 0 to 5=normal ; 6 and 9 = high probability of depression ; > 9 = almost systematic depression | At inclusion, 3 months and 6 months | 
| Impact of the program on self-efficacy | Self-efficacy for exercise scale - This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise. | At inclusion, 3 months and 6 months | 
| Impact of the program on comorbidities | Cumulativ Illness Rating Scale - Geriatric (CIRS-G) ; 14 items ; for each one, score from 0 to 4 : 0=no problem and 4=serious issue | At inclusion, 3 months and 6 months | 
| Impact of the program on health-related quality of life | European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) - scale from 0 to 100 | At inclusion, 3 months, 6 months and 1 year | 
| Impact of the program on fatigue | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) ; score from 0 to 65 ; the higher the score is, the less the patient has fatigue | At inclusion, 3 months, 6 months and 1 year | 
| Impact of the program on the level of physical activity | Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) ; Godin scale score: < 14 units: insufficiently active/sedentary ; 14-23: moderately active ; 24 or more : active | At inclusion, 3 months, 6 months and 1 year | 
| Impact of the program on exercise barriers | Barriers to Being Active Quiz | At inclusion, 3 months, 6 months and 1 year | 
| Impact of the program on social vulnerability | Évaluation de la précarité et des inégalités de santé pour les CES (EPICES questionnaire) - scale from 0 to 100, 0= no social vulnerability, 100=max vulnerability, threshold=30 | At inclusion and 1 year | 
| Impact of the program on falls | Number of falls | At inclusion and 1 year |