Effect of a Brief Therapeutic Patient Education Session on Physical Activity in Patients at the Onset of Cancer Therapy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Changes in PA level
研究概览
简要总结
Despite significant evolution of cancer therapies from the early 20th century, these therapies are still associated with toxic effects that negatively impact the patient's performance status, quality of life and survival. The role of physical activity to counteract these side effects is acknowledged. However, cancer patients are often misinformed about the potential benefits of physical therapy during cancer therapy. In this context, the role of therapeutic patient education seems essential.
Because of lack of time, therapeutic patient education (TPE) is often provided via an information booklet. However, the investigators assume that a face-to-face interview results in a greater impact on patient's behavior change (the level of physical activity during cancer therapy, in our case). This research project is designed to challenge this hypothesis. The investigators hypothesize that a brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the physical activity level of our patients for at least 6 months, i.e. during their cancer therapy.
详细描述
The investigators aim to compare the effects of two forms of TPE on the patient's PA level. In one of the two forms, TPE is delivered using an information booklet accompanied with a semi-structured oral interview (intervention group), whereas in the other form TPE is only delivered via the booklet (control group). The investigators hypothesize that the brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the PA level of our patients for at least 6 months, i.e. during their cancer therapy.
The study is designed as a double-blind randomized controlled trial. The primary outcome is the evolution in each group of the PA level (via the international physical activity questionnaire (IPAQ) - long form) between the start of cancer therapy and 6-month follow-up.
Eligible patients will be randomly assigned either to the intervention group (TPE includes the information booklet + the semi-structured oral intervention provided by a physiotherapist) or to the control group (TPE will consist only in the information booklet). Patients and assessors will be blinded.
The relative efficacy of these 2 treatment arms will be evaluated at baseline, after 3 months at a visit for a follow-up medical consultation set by the oncologist, and after 6 months at a second follow-up consultation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 84 years
- •Suffering from a first cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):
- •non-melanoma skin cancer,
- •carcinoma in situ of the uterine cervix
- •ductal carcinoma in situ.
- •Preserved performance status (ECOG scale ≤ 1),
- •Starting one of the following systemic cancer therapies:
- •chemotherapy,
- •immunotherapy,
- •targeted therapies,
- •Able to understand and read French
- •Life expectancy of at least 1 year
排除标准
- •Poor cognitive function (Mini-Mental State Examination ≤ 24/30)
- •Having a recurrence of cancer, with the exception of the following cancers in the patient's history (provided that they have been successfully treated):
- •non-melanoma skin cancer,
- •carcinoma in situ of the uterine cervix,
- •ductal carcinoma in situ.
结局指标
主要结局
Changes in PA level
时间窗: At baseline and 6 months (at the occasion of a second follow-up visit set with the oncologist) after the start of the cancer therapy
The PA level will be estimated in MET/h/week via the International Physical Activity Questionnaire (long form) validated in French in subjects aged 18-84 years. The questionnaire classifies the subject according to 3 activity levels: inactive, moderate, high
次要结局
- Changes in BMI(At baseline, 3 months and 6 months after the start of the cancer therapy)
- Changes in fatigue(At baseline, 3 months and 6 months after the start of the cancer therapy)
- Changes in quality of life(At baseline, 3 months and 6 months after the start of the cancer therapy)
- Changes in PA level(At baseline and 3 months (at the occasion of a first follow-up visit set with the oncologist) after the start of the cancer therapy)
- Changes in exercise capacity(At baseline, 3 months and 6 months after the start of the cancer therapy)
- Changes in handgrip strength test(At baseline, 3 months and 6 months after the start of the cancer therapy)
- Number of steps(At 3 months and 6 months after the start of the cancer therapy)
- Number of patients entering a group of exercise medicine(At 6 months after the start of the cancer therapy)
研究者
William Poncin, PT, PhD
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain