An observational study for monitoring mental health predictors, such as activity, sleep, nutrition and voice, in cancer survivors
- Conditions
- Depression symptoms and quality of life of cancer survivorsMental and Behavioural Disorders
- Registration Number
- ISRCTN10423782
- Lead Sponsor
- European Commission
- Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36544126/ (added 30/03/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 300
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+/-)
Or
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The severity of depressive symptoms measured by the Hamilton Depression Rating Scale (Ham-D) at months 3, 6, 9 and 12 post-baseline
- Secondary Outcome Measures
Name Time Method <br> 1. Anxiety and distress measured using the Hospital Anxiety and Depression Scale (HADS) at baseline and monthly until 12-months post-baseline<br> 2. Perceived quality of life measured using European Organisation for Research and Treatment of Cancer (EORTC) questionnaires at baseline and monthly until 12-months post-baseline<br>