LOG-I - Impact Study of LOG-AFTER Software on Long-term Monitoring of Former Patients (LOG-I - LOG-Impact Study) / Etude d'Impact du Logiciel LOG-AFTER Sur le Suivi à Long Terme Des Anciens Patients (LOG-I - LOG-Impact Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- PPAC adherence
研究概览
简要总结
Childhood cancer survivors represent a high-risk population that requires risk-based follow-up. Follow-up recommendations have been harmonized. Education and information practices regarding follow-up recommendations should be personalized, to ensure understanding by all survivors, including those with neurocognitive disorders. Individualized follow-up is necessary to detect complications that may increase morbidity and decrease quality of life, or even increase the risk of early mortality.
In France, the LOG-AFTER software was developed in 2017 by university hospital of Angers and Epiconcept (approved health data host). The main differences with the European procedure concern radiotherapy information, the link with the General practitioner (GP), and the possible addition of information and/or access to therapeutic education in a video format. Indeed, there is the possibility of creating an GP account allowing to receive notifications concerning the follow-up of his patient to be scheduled, to have access to his file summary and his personalized follow-up plan, various information and blank prescription models. LOG-I is a study of the impact of the LOG-AFTER software for the "patient/GP" couple on adherence to follow-up recommendations. LOG-I is interested in all former patients with at least 3 recommendations in their personalized follow-up plan, taking into account the specific population of patients cured of a brain tumor.
详细描述
Recruitment as long-term follow-up consultations progress. After checking the selection criteria, the investigator informs the patient of the study or the parents of the minor child orally and in writing with delivery of the information letter and answers any questions. If the patient, or their parents for minor patients, agrees to participate, the informed consent form is signed in 2 copies by the different parties. The date of the information and the date of signature of the consent are documented in the patient's source file. Following the inclusion of the patient, randomization is carried out (WITH and WITHOUT use of the LOG-AFTER software).
During this visit, for patients randomized in the LOG-AFTER software, an account is created within 5 days following the consultation.
For all patients (randomized with or without access to LOG-AFTER) the following data are collected in LOG-AFTER:
- Health data: type of first cancer, start and end dates of treatment
- Patient data required for research: gender, month and year of birth, after-effects, psychosocial data (level of education, life as a couple and children if concerned, profession if concerned).
The module to help create the Personalized After-Cancer Plan (PPAC) can be used for everyone and the PPAC is recorded in LOG-AFTER.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously treated for cancer or malignant hematological pathology before the age of 25
- •Without residual disease or with a stable disease without treatment for 5 years or more
- •Owning a computer, smartphone or equivalent I-Pad/tablet with internet access
- •Having signed the consent (or their parents if the patient is a minor, or a third party if necessary)
- •Having 3 or more recommended screenings in their survivorship care plan
- •No access created to LOG-AFTER before the study or having never connected after opening their account if opening an account dating back 24 months or more at the time of inclusion
排除标准
- •Patient who has relapsed or developed a second cancer with a post-treatment delay < 5 years
- •Patient not covered by a health insurance
- •Patient subject to a legal protection measure, patient deprived of liberty by judicial or administrative decision, patient subject to psychiatric care under duress
结局指标
主要结局
PPAC adherence
时间窗: 3 years
Evaluate the impact of LOG-AFTER on former patients' adherence to the Personalized After-Cancer Plan (PPAC) for those with at least 3 follow-up examinations. (Adherence = For a number of screens between three and six (3-6), adherence is considered adequate if all screens or all but one screen have been completed. For seven or more screens (\>7), it is considered adequate if all screens or all but two screens have been completed)
次要结局
- Describe the patient satisfaction(3 years)
- GP satisfaction(3 years)
- Describe the use(3 years)
- Empowerment(3 years)
- PPAC adherence for survivors of brain tumor treated, at least, with radiotherapy(3 years)
- Health status(3 years)
- PPAC adherence for new cancer survivors partients starting long term follow-up(3 years)
- PPAC adherence for cancer survivors already involved in long term follow-up before the study(3 years)