Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 主要终点
- Validate the feasibility of a supervised adapted physical activity (APA) program during the first 7 days of hospitalization in medical oncology for patients with cancer undergoing treatment
研究概览
简要总结
This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.
It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.
At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.
At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 18 and over (no age limit)
- •Patient followed for cancer,
- •Patients with no medical contraindication to adapted physical activity (certificate)
- •Patient with a performance index status less than 4
- •Patient hospitalized in the conventional medical oncology hospitalization department of Besançon University Hospital.
- •Patient not opposed to participating in the study
- •Patient affiliated to a French social security scheme or beneficiary of such a scheme.
- •For women: menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, patches contraceptives)
- •Length of hospitalization estimated at at least 7 days (main objective) and with the patient's objective of returning home or to SSR in the long term
排除标准
- •Patient with an absolute medical contraindication to adapted physical activity
- •Patient with inability to understand instructions and complete questionnaires.
- •Patient with a performance index status of 4
- •Patient with legal incapacity or limited legal capacity
- •Patient unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
- •Patient without health insurance
- •Pregnant woman
- •Patient being in the exclusion period of another study or provided for by the "national volunteer file".
研究组 & 干预措施
Adapted physical activity program (APA Program)
An intervention (APA program) will be offered to patients hospitalized in the conventional hospitalization department of the medical oncology department.
At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program.
At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.
干预措施: adapted physical activity program (APA Program) (Other)
结局指标
主要结局
Validate the feasibility of a supervised adapted physical activity (APA) program during the first 7 days of hospitalization in medical oncology for patients with cancer undergoing treatment
时间窗: 7 days after inclusion
The main objective of the study is to validate that the proportion of patients having completed, from inclusion (D0), at least three supervised APA sessions of a minimum duration of 15 minutes, during the first 7 consecutive days of his hospitalization (P) is beyond a threshold considered uninteresting of 50% (P0) To test the following hypotheses: H0: a compliant patient rate \<= 50% is uninteresting (P\<=P0) H1: a compliant patient rate \> 80% is expected (P\>P1) With an A'Hern type design, a one-sided alpha risk of 2.5% and a power of 90%, it is required to include 28 evaluable patients in the study to test H0 vs H1. Considering a rate of unevaluable patients of 10% it will be necessary to include 32 patients. Hypothesis H0 will be rejected if 20 (71.4%) or more than 20 patients out of the first 28 evaluable are compliant.
次要结局
- Describe the evolution of physical parameters functional capacities(At inclusion (day 1) and at the study completion, an average of 15 days)
- Tolerance with the APA program on perception of effort(immediately after each intervention session)
- Describe the evolution of muscular strength(At inclusion (day 1) and at the study completion, an average of 15 days)
- Describe the evolution of the quality of life(At inclusion (day 1) and at the study completion, an average of 15 days)
- Tolerance with the APA program on pain and fatigue(Immediately before and after each intervention session)
- Compliance with the APA program(at the study completion, an average of 15 days)
- Criteria/reasons for non-participation, non-compliance, discontinuation of the intervention and study withdrawals(at the study completion, an average of 15 days)
- Patient satisfaction(at the study completion, an average of 15 days)
- Describe the evolution of body composition measured by impedancemetry(At inclusion (day 1) and at the study completion, an average of 15 days)
- Describe the evolution of autonomy in daily life activities(At inclusion (day 1) and at the study completion, an average of 15 days)
- Describe the evolution of motivation to practice physical activity(At inclusion (day 1) and at the study completion, an average of 15 days)
- Tolerance with the APA program on fatigue(Immediately before and after each intervention session)