Assessment of Adherence to Remotely Monitored Physical Activity Tracked on a Smartwatch, and Its Impact on Reducing Fatigue 3 Months After Adjuvant Chemotherapy for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- adherence to the adapted physical activity (APA) program by the percentage of patients who completed 75% of the weekly sessions of the APA program with a heart rate (HR) between 40 and 60% of their reserve HR for 20-40 minutes.
研究概览
简要总结
A single-center, randomized (1:1) open-label, prospective, stratified study with two parallel arms, designed to evaluate adherence to the adapted physical activity (APA) program for patients participating in an APA program and to compare changes in fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 75 years old,
- •Histologically proven non-metastatic adenocarcinoma of breast, colorectal, ovarian, pancreatic, biliary, or gastric origin,
- •Adjuvant chemotherapy completed less than 3 months ago (excluding hormone therapy),
- •PS 0 or 1 according to the World Health Organization (WHO) scale,
- •No recurrence since the end of adjuvant chemotherapy,
- •Patient who has voluntarily agreed to participate in the study and sign the written informed consent form,
- •Patient affiliated with a Social Security scheme.
排除标准
- •New cancer treatment planned (excluding hormone therapy),
- •Patient who has received adjuvant immunotherapy,
- •Cardiological contraindication to the program
- •Decompensated or unstable chronic conditions
- •Severe malnutrition
- •Rheumatological unfitness as determined by the oncologist,
- •Chronic respiratory failure requiring long-term O2 therapy
- •Diabetes with plantar ulceration
- •Progressive or chronic non-healing bedsore/wound
- •Recent unhealed fracture
- •Patient participating in another interventional clinical study at the time of signing the informed consent form.
- •Vulnerable persons as defined in Articles L1121-5 to -8
研究组 & 干预措施
APA
participating to an APA program
干预措施: APA program (Other)
control arm
no APA program
结局指标
主要结局
adherence to the adapted physical activity (APA) program by the percentage of patients who completed 75% of the weekly sessions of the APA program with a heart rate (HR) between 40 and 60% of their reserve HR for 20-40 minutes.
时间窗: 3 months
Assessing adherence to the adapted physical activity (APA) program for patients participating in an APA program
evolution of fatigue in patients who are participating in an APA program by the difference in Multidimensional Fatigue Inventory (MFI-20) questionnaire scores (20 items) between the first and last visit at 3 months.
时间窗: 3 months
Compare the evolution of fatigue at 3 months in patients who have completed adjuvant systemic chemotherapy for cancer and are participating in an APA program. Items are scored 1-5, with 10 positively phrased items reverse scored (items 2, 5, 9, 10, 13, 14, 16, 17, 18, 19). Total score calculated for 5 subscales: general fatigue (items 1, 5, 12, 16), physical fatigue (items 2, 8, 14, 20), reduced activity (items 7, 11, 13, 19), reduced motivation (items 3, 6, 10, 17), and mental fatigue (items 4, 9, 15, 18)." High MFI scores indicate a high degree of fatigue.
次要结局
- evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100](6 months)
- evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0; 100](12 months)
- evaluation of quality of life with EORTC QLQ-C30 questionnaire score [0;100](3 months)
- Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126](3 months)
- Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126](6 months)
- Comparaison of the motivation for physical activity by the difference in scores on the EMAPS scale [18;126](12 months)
- Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 6 months, in patients who followed the APA program versus standard follow-up(6 months)
- Compare the evolution of fatigue with MFI-20 questionnaire scores (20 items) between the first and last visit at 12 months, in patients who followed the APA program versus standard follow-up(12 months)