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

Quality of Life Clinical Trial

— OCAPI  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052126
• Other study ID #: OCAPI
• Status: Completed
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: May 30, 2023

Study information

• Verified date: August 2023
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 30, 2023
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Compliance rate of the phone calls	Ratio of the number of phone calls performed / number of scheduled calls	6 months
Primary	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	Acceptability of the intervention	Ratio of number of patients included / number of eligible patients	At inclusion
Secondary	Safety of the intervention	Number, type and timing of program-related adverse events	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Impact of the program on upper body strength	30-s Arm Curl Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on lower body strength	30-s Chair Stand Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on upper body flexibility	Back Scratch Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on lower body flexibility	Chair Sit and Reach Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on agility	Timed Up and Go Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on walking endurance	6-min Walk Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on walking speed	10-m Walk Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on balance	Open-eyes Unipodal Test	At inclusion, 3 months and 6 months
Secondary	Impact of the program on grip strength	Hand Grip Dynamometer Test	At inclusion, 3 months and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Impact of the program on exercise barriers	Barriers to Being Active Quiz	At inclusion, 3 months, 6 months and 1 year
Secondary	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
Secondary	Impact of the program on falls	Number of falls	At inclusion and 1 year