ISRCTN10423782进行中（未招募）未知
A Federated Artificial Intelligence solution for moniToring mental Health status after cancer treatment
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36544126/ (added 30/03/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Eligible participants include both breast and lung cancer patients who will be recruited after the end of primary cancer treatments (1-5 years after), and should meet the following criteria:
- •1. Signed informed consent
- •2. Age between 18-70 years
- •3. Native or fluent English/Spanish/Portuguese speakers
- •4. If Apple iPhone users: have iOS 14+/ If Android device users: have Android 7+ and Google Fit installed on the device
- •5. Cancer survivors complying patients after chemotherapy, radiotherapy or surgery with curative purposes treatment, divided as follows:
- •5.1. Early breast cancer, stages I-III, of the subtypes:
- •5.1.1. Luminal A-like
- •5.1.2. Luminal B-like
- •5.1.3. Luminal B HER2+ (HR+/-)
- •5.2. Lung cancer patients, with non-small cells lung carcinoma, of subtypes:
- •5.2.1. Stages I-IIIA
- •5.2.1. Stages I-IIIB
- •6. Performance status (ECOG): 0-2
- •7. Disease-specific treatments, to reduce the minimal risk of recurrence or relapse, are accepted according to each cancer subtype
排除标准
- •Clinical exclusion criteria include:
- •1. The presence of distant metastases
- •2. A previous invasive malignancy whose treatment was completed within 5 years before the diagnosis of the current neoplastic disease (exceptions: patients with adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ are eligible)
- •3. Any acute medical illness or other diagnosed concomitant disease clinically significant (i.e. active), such as cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease or cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months
- •4. A major surgery for a severe disease or trauma which could affect a patient’s psychosocial wellbeing (for example, major heart or abdominal surgery) within 4 weeks prior to study entry or lack of complete recovery from the effects of surgery
- •5. Treatment for any major illness in the last half year
- •6. Pregnancy or breastfeeding at time of recruitment
- •7. A diagnosis of a moderate to severe major depressive episode at baseline according to the MINI (diagnosis) and/or Ham-D17 (severity)
- •8. A current or previous hypomanic or manic episode, current or previous psychotic disorder or current mood disorder with psychotic symptoms, as well as substance abuse or dependence in the last 12 months, as screened by the MINI
- •9. Presence of any psychiatric disorder requiring urgent care or hospitalization at the time of recruitment
- •10. Cognitive impairment, such as dementia or other active neurodegenerative disease
- •11. Previously known structural lesion of the central nervous system (e.g., stroke)
- •12. Developmental disorders with low intelligence quotient or any other form of cognitive impairment
- •13. Illiteracy or otherwise not understanding instructions for the study
研究者
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