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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Compliance rate of the activity tracker
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Individualized physical activity program
干预措施: Individualized physical activity program (Other)
结局指标
主要结局
Compliance rate of the activity tracker
时间窗: 6 months
Ratio of the number of days wearing the activity tracker / number of days of the program
Compliance rate of the physical activity sessions
时间窗: 6 months
Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions
Compliance rate of the phone calls
时间窗: 6 months
Ratio of the number of phone calls performed / number of scheduled calls
次要结局
- Impact of the program on depression(At inclusion, 3 months and 6 months)
- Impact of the program on upper body strength(At inclusion, 3 months and 6 months)
- Acceptability of the intervention(At inclusion)
- Safety of the intervention(6 months)
- Adherence of the intervention(3 months and 6 months)
- Impact of the program on lower body strength(At inclusion, 3 months and 6 months)
- Impact of the program on agility(At inclusion, 3 months and 6 months)
- Impact of the program on autonomy for activities of daily living(At inclusion, 3 months and 6 months)
- Impact of the program on autonomy for instrumental activities of daily living(At inclusion, 3 months and 6 months)
- Impact of the program on upper body flexibility(At inclusion, 3 months and 6 months)
- Impact of the program on lower body flexibility(At inclusion, 3 months and 6 months)
- Impact of the program on walking endurance(At inclusion, 3 months and 6 months)
- Impact of the program on walking speed(At inclusion, 3 months and 6 months)
- Impact of the program on grip strength(At inclusion, 3 months and 6 months)
- Impact of the program on the level of physical activity(At inclusion, 3 months, 6 months and 1 year)
- Impact of the program on exercise barriers(At inclusion, 3 months, 6 months and 1 year)
- Impact of the program on falls(At inclusion and 1 year)
- Impact of the program on balance(At inclusion, 3 months and 6 months)
- Impact of the program on cognition(At inclusion, 3 months and 6 months)
- Impact of the program on self-efficacy(At inclusion, 3 months and 6 months)
- Impact of the program on anthropometrics(At inclusion, 3 months and 6 months)
- Impact of the program on health-related quality of life(At inclusion, 3 months, 6 months and 1 year)
- Impact of the program on social vulnerability(At inclusion and 1 year)
- Impact of the program on nutrition(At inclusion, 3 months and 6 months)
- Impact of the program on comorbidities(At inclusion, 3 months and 6 months)
- Impact of the program on fatigue(At inclusion, 3 months, 6 months and 1 year)