An observational study for monitoring mental health predictors, such as activity, sleep, nutrition and voice, in cancer survivors

ISRCTN	ISRCTN10423782
DOI	https://doi.org/10.1186/ISRCTN10423782

Submission date: 21/09/2021
Registration date: 21/03/2022
Last edited: 30/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Depression is a common condition among cancer patients but is often not reported or goes unnoticed. It becomes more challenging to track patients’ psychological changes in the period after treatment where the connection with the healthcare environment becomes sporadic.
This study is part of a project sponsored by the European Community and the main goal is to identify and predict depressive symptoms in breast and lung cancer patients through a mobile App. The clinical centres involved are Euro Care Healthcare Limited (UPMC, Ireland), Hospital General Universitario Gregorio Marañón, (HGUGM, Spain) and Champalimaud Foundation (CF, Portugal).

Who can participate?
Lung or breast cancer patients from Portugal, Spain and Ireland, aged 18 to 70 years

What does the study involve?
Participants will be asked to directly or indirectly provide information on quality of life, depression and anxiety symptoms, nutrition, voice, sleep and activity that can be assessed either through questionnaires or an app. The questionnaires evaluate different aspects of quality of life, depressive and anxiety symptoms and nutrition, and some of these will need completion on an app every month, for a total of 12 months. About 15 to 60 minutes of time will be required at each timepoint to complete these self-rated questionnaires. Every 3 months, a clinical member of the research team will contact participants by telephone for the completion of a structured interview about mood status. This interview lasts about 45 minutes. Participants will be asked to respond to a question and read a small text through the app every month. This action has a duration of about 5 minutes. For the collection of sleep information, participants will be asked to wear a smart band on their wrist, smaller than a watch, that gathers relevant information automatically. Furthermore, participants will be asked to provide some sleep-related information monthly and to fill in a questionnaire every 3 months regarding their sleep habits. For the collection of activity information, all data will be extracted automatically through the app. Any time an action is required (questionnaires, voice recording or any other information), participants will receive a notification on their mobile phone.

What are the possible benefits and risks of participating?
There are no direct benefits related to participation in the study. However, participation will help the researchers to understand how to provide better support to cancer patients after treatment, as well as guidance for health professionals in monitoring mental health. Therefore, the results will benefit future patients and could lead to the development of patient support tools. As the study is a monitoring exercise and will not involve any test or procedure on the participants there will be no risk to the health or well-being of any person.

Where is the study run from?
Waterford Institute of Technology (Ireland)

When is the study starting and how long is it expected to run for?
January 2020 to May 2023

Who is funding the study?
European Commission

Who is the main contact?
Mr Gary McManus
gary.mcmanus@waltoninstitute.ie

Contact information

Mr Gary McManus
Public

Mobile Ecosystem and Pervasive Sensing, TSSG
Telecommunications Software & Systems Group (TSSG)
ArcLabs Research and Innovation Building
Waterford Institute of Technology
Carriganore Campus, Carriganore
Co. Waterford
Waterford
X91 P20H
Ireland

ORCID ID	0000-0002-8518-4202
Phone	+353 (0)87 6432221
Email	gary.mcmanus@waltoninstitute.ie

Study information

Study design	Longitudinal prospective observational cohort study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	https://cordis.europa.eu/project/id/875358
Scientific title	A Federated Artificial Intelligence solution for moniToring mental Health status after cancer treatment
Study acronym	FAITH
Study hypothesis	The primary objective of the FAITH project is to remotely identify and predict the risk or negative trends of depression in cancer survivor patients. FAITH models will significantly detect depressive symptoms in cancer survivors.
Ethics approval(s)	Approved 07/12/2021, Champalimaud Foundation's Ethics Committee (Champalimaud Foundation Administration, Avenida Brasília, 1400-038 Lisboa, Portugal; +351 (0)210 480 200; andre.valente@research.fchampalimaud.org), ref: Albino.Maia_9_20211207
Condition	Depression symptoms and quality of life of cancer survivors
Intervention	The study is designed as a 12-month longitudinal prospective observational cohort, with monthly (± 1 week) assessments after the end of primary cancer treatments ([1-5] years after), to evaluate depression symptoms and quality of life of cancer survivors. As the study is not interventional, change in behaviours regarding markers will be traced but not used as alarms for potential depression, as this could not be ensured until all data analysis is performed with the complete set of data. Participants will be asked to directly or indirectly provide information on quality of life, depression and anxiety symptoms, nutrition, voice, sleep and activity that can be assessed either through questionnaires or an app. The questionnaires evaluate different aspects of quality of life, depressive and anxiety symptoms and nutrition, and some of these will need completion on an app every month, for a total of 12 months. About 15 to 60 minutes of time will be required at each timepoint to complete these self-rated questionnaires. Every 3 months, a clinical member of the research team will contact participants by telephone for the completion of a structured interview about mood status. This interview lasts about 45 minutes. Participants will be asked to respond to a question and read a small text through the app every month. This action has a duration of about 5 minutes. For the collection of sleep information, participants will be asked to wear a smart band on their wrist, smaller than a watch, that gathers relevant information automatically. Furthermore, participants will be asked to provide some sleep-related information monthly and to fill in a questionnaire every 3 months regarding their sleep habits. For the collection of activity information, all data will be extracted automatically through the app. Any time an action is required (questionnaires, voice recording or any other information), participants will receive a notification on their mobile phone.
Intervention type	Other
Primary outcome measure	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	1. Anxiety and distress measured using the Hospital Anxiety and Depression Scale (HADS) at baseline and monthly until 12-months post-baseline 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
Overall study start date	01/01/2020
Overall study end date	30/05/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	70 Years
Sex	Both
Target number of participants	300
Participant inclusion criteria	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
Participant exclusion criteria	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
Recruitment start date	01/04/2022
Recruitment end date	01/07/2022

Locations

Countries of recruitment

Ireland
Portugal
Spain

Study participating centres

Fundação D. Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud

Avenida Brasilia Centro De Investigacao Da Fundacao Champ Alimaud
Lisbon
1400 038
Portugal

Hospital General Universitario Gregorio Marañón. Servicio Madrileño de Salud

Plaza Carlos Trias, Bertran 7
Madrid
28020
Spain

Care Healthcare Ltd (UPMC Whitfield)

Butlerstown
North Cork Road
Waterford
X91 DH9W
Ireland

Sponsor information

European Commission
Government

12, rue Robert Stümper
L-2557
PO Box L-2920
Luxembourg
L-2557
Luxembourg

Phone	+32 (0)2 299 11 11
Email	cnect-eHealth@ec.europa.eu
Website	http://ec.europa.eu/index_en.htm
"ROR"	https://ror.org/00k4n6c32

Funders

Funder type

Government

European Commission
Government organisation / National government

Alternative name(s): European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU

Results and Publications

Intention to publish date	31/12/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal. The study protocol is in the final stages of updates based on feedback from the ethics board and can be submitted on completion.
IPD sharing plan	Participant level data is private health data to be held within the hospitals and so is not suitable for public consumption. As part of the Informed Consent the researchers will be asking for permission for use of this data in future research and can change this record if there are sufficient approvals to make a difference.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article		21/12/2022	30/03/2023	Yes	No

Editorial Notes

30/03/2023: Publication reference added.
09/02/2022: Trial's existence confirmed by Champalimaud Foundation's Ethics Committee.