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

NCT04052126 | Completed

• 1 other identifier: OCAPI
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Compliance rate of the physical activity sessions

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

  6 months

• Compliance rate of the phone calls

  Ratio of the number of phone calls performed / number of scheduled calls

  6 months

• Compliance rate of the activity tracker

  Ratio of the number of days wearing the activity tracker / number of days of the program

  6 months

Secondary Outcomes (26)

• Acceptability of the intervention

  At inclusion

• Safety of the intervention

  6 months

• Adherence of the intervention

  3 months and 6 months

• Impact of the program on autonomy for activities of daily living

  At inclusion, 3 months and 6 months

• Impact of the program on autonomy for instrumental activities of daily living

  At inclusion, 3 months and 6 months

Study Arms (1)

Individualized physical activity program

EXPERIMENTAL

Other: Individualized physical activity program

Interventions

Individualized physical activity program 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.

Individualized physical activity program

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, 69008, France

Location

Related Publications (1)

• 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.

  PMID: 34083339 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emmanuelle NICOLAS-VIRELIZIER

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: November 28, 2019
• Primary Completion: November 23, 2022
• Study Completion: May 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)