Clinical trial · Interventional
An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aged | — | UNRESOLVED | — |
| Aged, 80 and Over | — | UNRESOLVED | — |
| Exercise | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Leukemia, Myeloid, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized physical activity program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Individualized physical activity program
- interventionNames
- Other: Individualized physical activity program
Primary outcomes (3)
- measure
- Compliance rate of the physical activity sessions
- timeFrame
- 6 months
- description
- Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions
- measure
- Compliance rate of the phone calls
- timeFrame
- 6 months
- description
- Ratio of the number of phone calls performed / number of scheduled calls
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDFournier 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. PMID 34083339