Clinical trial NCT04052126: An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Aged, 80 and Over
Leukemia, Myeloid, Acute
Lymphoma, Non-Hodgkin
Exercise
Quality of Life
Fatigue
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 43
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Compliance rate of the physical activity sessions
timeFrame: 6 months
measure: Compliance rate of the phone calls
timeFrame: 6 months
measure: Compliance rate of the activity tracker
timeFrame: 6 months
Secondary outcomes:
measure: Acceptability of the intervention
timeFrame: At inclusion
measure: Safety of the intervention
timeFrame: 6 months
measure: Adherence of the intervention
timeFrame: 3 months and 6 months
measure: Impact of the program on autonomy for activities of daily living
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on autonomy for instrumental activities of daily living
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on upper body strength
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on lower body strength
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on upper body flexibility
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on lower body flexibility
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on agility
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on walking endurance
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on walking speed
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on balance
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on grip strength
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on anthropometrics
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on nutrition
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on cognition
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on depression
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on self-efficacy
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on comorbidities
timeFrame: At inclusion, 3 months and 6 months
measure: Impact of the program on health-related quality of life
timeFrame: At inclusion, 3 months, 6 months and 1 year
measure: Impact of the program on fatigue
timeFrame: At inclusion, 3 months, 6 months and 1 year
measure: Impact of the program on the level of physical activity
timeFrame: At inclusion, 3 months, 6 months and 1 year
measure: Impact of the program on exercise barriers
timeFrame: At inclusion, 3 months, 6 months and 1 year
measure: Impact of the program on social vulnerability
timeFrame: At inclusion and 1 year
measure: Impact of the program on falls
timeFrame: At inclusion and 1 year
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Emmanuelle NICOLAS-VIRELIZIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.