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

NCT ID: NCT04052126

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2023-05-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Individualized physical activity program

Group Type: EXPERIMENTAL

Individualized physical activity program

Intervention Type: OTHER

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.

Interventions

Individualized physical activity program

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle NICOLAS-VIRELIZIER

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Locations

Centre Léon Bérard

Lyon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34083339 (View on PubMed)

Other Identifiers

OCAPI

Identifier Type: -

Identifier Source: org_study_id