An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies
- Conditions
- ExerciseQuality of LifeLeukemia, Myeloid, AcuteFatigueAgedAged, 80 and OverLymphoma, Non-Hodgkin
- Interventions
- Other: Individualized physical activity program
- Registration Number
- NCT04052126
- Lead Sponsor
- Centre Leon Berard
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Individualized physical activity program Individualized physical activity program -
- Primary Outcome Measures
Name Time Method 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
Name Time Method Impact of the program on falls At inclusion and 1 year Number of falls
Impact of the program on upper body strength At inclusion, 3 months and 6 months 30-s Arm Curl Test
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 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 lower body strength At inclusion, 3 months and 6 months 30-s Chair Stand Test
Impact of the program on agility At inclusion, 3 months and 6 months Timed Up and Go Test
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 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 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 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 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 grip strength At inclusion, 3 months and 6 months Hand Grip Dynamometer Test
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 balance At inclusion, 3 months and 6 months Open-eyes Unipodal Test
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 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 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 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 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 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 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
Trial Locations
- Locations (1)
Centre Léon Bérard
🇫🇷Lyon, France