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

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.

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Lymphoma, Non-Hodgkin; Leukemia, Myeloid, Acute; Fatigue; Exercise; Aged; Aged, 80 and Over
• Intervention / Treatment: Other: Individualized physical activity program

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Leon Berard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Individualized physical activity program

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the intervention	Ratio of number of patients included / number of eligible patients	At inclusion
Safety of the intervention	Number, type and timing of program-related adverse events	6 months
Adherence of the intervention	Ratio of the number of patients still in the program / number of patients included in the study	3 months and 6 months
Impact of the program on autonomy for activities of daily living	Activities of Daily Living questionnaire (ADL) - scale from 0 to 6, 0=autonomy; 6 = no autonomy	At inclusion, 3 months and 6 months
Impact of the program on autonomy for instrumental activities of daily living	Instrumental activities of Daily Living questionnaire (IADL) - scale from 0 to 4, 0=autonomy; 4 = no autonomy	At inclusion, 3 months and 6 months
Impact of the program on upper body strength	30-s Arm Curl Test	At inclusion, 3 months and 6 months
Impact of the program on lower body strength	30-s Chair Stand Test	At inclusion, 3 months and 6 months
Impact of the program on upper body flexibility	Back Scratch Test	At inclusion, 3 months and 6 months
Impact of the program on lower body flexibility	Chair Sit and Reach Test	At inclusion, 3 months and 6 months
Impact of the program on agility	Timed Up and Go Test	At inclusion, 3 months and 6 months
Impact of the program on walking endurance	6-min Walk Test	At inclusion, 3 months and 6 months
Impact of the program on walking speed	10-m Walk Test	At inclusion, 3 months and 6 months
Impact of the program on balance	Open-eyes Unipodal Test	At inclusion, 3 months and 6 months
Impact of the program on grip strength	Hand Grip Dynamometer Test	At inclusion, 3 months and 6 months
Impact of the program on anthropometrics	BMI (weight and height will be combined to report BMI in kg/m^2)	At inclusion, 3 months and 6 months
Impact of the program on nutrition	Mini Nutritional Assessment (MNA) - scale from 0 to 30 points; score<17=bad nutritional status ; 17 and 23.5=risk of malnutrition ; >24: adaptednutritional status	At inclusion, 3 months and 6 months
Impact of the program on cognition	Montreal Cognitive Assessment (MoCA) ; scale from 0 to 30; normal if score >16	At inclusion, 3 months and 6 months
Impact of the program on depression	Geriatric Depression Scale-15 (GDS-15) ; scale from 0 to 15 ; 0 to 5=normal ; 6 and 9 = high probability of depression ; > 9 = almost systematic depression	At inclusion, 3 months and 6 months
Impact of the program on self-efficacy	Self-efficacy for exercise scale - This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.	At inclusion, 3 months and 6 months
Impact of the program on comorbidities	Cumulativ Illness Rating Scale - Geriatric (CIRS-G) ; 14 items ; for each one, score from 0 to 4 : 0=no problem and 4=serious issue	At inclusion, 3 months and 6 months
Impact of the program on health-related quality of life	European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) - scale from 0 to 100	At inclusion, 3 months, 6 months and 1 year
Impact of the program on fatigue	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) ; score from 0 to 65 ; the higher the score is, the less the patient has fatigue	At inclusion, 3 months, 6 months and 1 year
Impact of the program on the level of physical activity	Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) ; Godin scale score: < 14 units: insufficiently active/sedentary ; 14-23: moderately active ; 24 or more : active	At inclusion, 3 months, 6 months and 1 year
Impact of the program on exercise barriers	Barriers to Being Active Quiz	At inclusion, 3 months, 6 months and 1 year
Impact of the program on social vulnerability	Évaluation de la précarité et des inégalités de santé pour les CES (EPICES questionnaire) - scale from 0 to 100, 0= no social vulnerability, 100=max vulnerability, threshold=30	At inclusion and 1 year
Impact of the program on falls	Number of falls	At inclusion and 1 year

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Emmanuelle NICOLAS-VIRELIZIER, Centre Leon Berard

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2019
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Hematologic Diseases; Leukemia; Lymphoma; Hematologic Neoplasms; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: OCAPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No