OCAPI: An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Individualized physical activity program
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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.
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Outcome Measures
Primary Outcome Measures
- Compliance rate of the physical activity sessions [6 months]
Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions
- Compliance rate of the phone calls [6 months]
Ratio of the number of phone calls performed / number of scheduled calls
- Compliance rate of the activity tracker [6 months]
Ratio of the number of days wearing the activity tracker / number of days of the program
Secondary Outcome Measures
- Acceptability of the intervention [At inclusion]
Ratio of number of patients included / number of eligible patients
- Safety of the intervention [6 months]
Number, type and timing of program-related adverse events
- Adherence of the intervention [3 months and 6 months]
Ratio of the number of patients still in the program / number of patients included in the study
- Impact of the program on autonomy for activities of daily living [At inclusion, 3 months and 6 months]
Activities of Daily Living questionnaire (ADL) - scale from 0 to 6, 0=autonomy; 6 = no autonomy
- Impact of the program on autonomy for instrumental activities of daily living [At inclusion, 3 months and 6 months]
Instrumental activities of Daily Living questionnaire (IADL) - scale from 0 to 4, 0=autonomy; 4 = no autonomy
- Impact of the program on upper body strength [At inclusion, 3 months and 6 months]
30-s Arm Curl Test
- Impact of the program on lower body strength [At inclusion, 3 months and 6 months]
30-s Chair Stand Test
- Impact of the program on upper body flexibility [At inclusion, 3 months and 6 months]
Back Scratch Test
- Impact of the program on lower body flexibility [At inclusion, 3 months and 6 months]
Chair Sit and Reach Test
- Impact of the program on agility [At inclusion, 3 months and 6 months]
Timed Up and Go Test
- Impact of the program on walking endurance [At inclusion, 3 months and 6 months]
6-min Walk Test
- Impact of the program on walking speed [At inclusion, 3 months and 6 months]
10-m Walk Test
- Impact of the program on balance [At inclusion, 3 months and 6 months]
Open-eyes Unipodal Test
- Impact of the program on grip strength [At inclusion, 3 months and 6 months]
Hand Grip Dynamometer Test
- Impact of the program on anthropometrics [At inclusion, 3 months and 6 months]
BMI (weight and height will be combined to report BMI in kg/m^2)
- Impact of the program on nutrition [At inclusion, 3 months and 6 months]
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
- Impact of the program on cognition [At inclusion, 3 months and 6 months]
Montreal Cognitive Assessment (MoCA) ; scale from 0 to 30; normal if score >16
- Impact of the program on depression [At inclusion, 3 months and 6 months]
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
- Impact of the program on self-efficacy [At inclusion, 3 months and 6 months]
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.
- Impact of the program on comorbidities [At inclusion, 3 months and 6 months]
Cumulativ Illness Rating Scale - Geriatric (CIRS-G) ; 14 items ; for each one, score from 0 to 4 : 0=no problem and 4=serious issue
- Impact of the program on health-related quality of life [At inclusion, 3 months, 6 months and 1 year]
European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) - scale from 0 to 100
- Impact of the program on fatigue [At inclusion, 3 months, 6 months and 1 year]
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
- Impact of the program on the level of physical activity [At inclusion, 3 months, 6 months and 1 year]
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) ; Godin scale score: < 14 units: insufficiently active/sedentary ; 14-23: moderately active ; 24 or more : active
- Impact of the program on exercise barriers [At inclusion, 3 months, 6 months and 1 year]
Barriers to Being Active Quiz
- Impact of the program on social vulnerability [At inclusion and 1 year]
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
- Impact of the program on falls [At inclusion and 1 year]
Number of falls
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 65 and over,
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With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML),
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Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination,
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Followed-up in one of the investigating centers,
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Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie,
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Having a ECOG < 3,
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With a life expectancy > 6 months,
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Whose ability to engage in physical activity has been certified by a medical certificate issued by the investigator physician,
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Available and willing to participate in the study for the duration of the intervention and follow-up,
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Able to understand, read and write French,
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Affiliated with a social security scheme,
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Having dated and signed an informed consent.
Exclusion Criteria:
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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),
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Treated by immunotherapy alone,
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Participating in concurrent physical activity studies,
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Deprived of their liberty by court or administrative decision.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Léon Bérard | Lyon | France | 69008 |
Sponsors and Collaborators
- Centre Leon Berard
Investigators
- Principal Investigator: Emmanuelle NICOLAS-VIRELIZIER, Centre Leon Berard
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OCAPI