Quality of Life Clinical Trial
— OCAPIOfficial 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.
NCT number | NCT04052126 |
Other study ID # | OCAPI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 28, 2019 |
Est. completion date | May 30, 2023 |
Verified date | August 2023 |
Source | Centre Leon Berard |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
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 |
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