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

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.

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.

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

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.

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

Instrumental activities of Daily Living questionnaire (IADL) - scale from 0 to 4, 0=autonomy; 4 = no autonomy

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

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

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.

Cumulativ Illness Rating Scale - Geriatric (CIRS-G) ; 14 items ; for each one, score from 0 to 4 : 0=no problem and 4=serious issue

European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) - scale from 0 to 100

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

Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) ; Godin scale score: < 14 units: insufficiently active/sedentary ; 14-23: moderately active ; 24 or more : active

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

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.

Fournier B, Nicolas-Virelizier E, Russo C, Perol O, Millet GY, Maire A, Delrieu L, Michallet AS, Assaad S, Belhabri A, Gilis L, Guillermin Y, Lebras L, Rey P, Santana C, Pretet-Flamand E, Terret C, Michallet M, Fervers B. Individualised physical activity programme in patients over 65 years with haematological malignancies (OCAPI): protocol for a single-arm feasibility trial. BMJ Open. 2021 Jun 3;11(6):e046409. doi: 10.1136/bmjopen-2020-046409.