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

L

Léon Bérard Center

Status

Completed

Conditions

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

Treatments

Other: Individualized physical activity program

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

43 participants in 1 patient group

Individualized physical activity program
Experimental group
Treatment:
Other: Individualized physical activity program

Trial contacts and locations

1

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Central trial contact

Olivia Pérol; Baptiste FOURNIER, PhD

Data sourced from clinicaltrials.gov

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