Cancer DiagnosisALTHEANCT07416513
Digital Solutions for bEtter cAre
A study testing Patients, survivors, caregivers, family members and healthcare professionals in people with Cancer Diagnosis, run by European Institute of Oncology at 5 sites in 5 countries.
Trial summary
The target population includes cancer patients, caregivers, family members, healthcare providers and mental health specialists, who will be the primary end-users of the Althea platform. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Diagnosis
- What is being tested?
- Patients, survivors, caregivers, family members and healthcare professionals
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 14 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HEALTHCARE PROFESSIONALS:
- Healthcare professionals actually working in oncology and/or psychooncology;
- Teachers of paediatric cancer patients.
- ADULT POPULATION:
- Patients with a current or previous cancer diagnosis
- Adequate language proficiency,
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- Able to provide informed consent;
- PAEDIATRIC POPULATION:
- Older than 12 years of age;
- Patients with a current or previous cancer diagnosis;
- Adequate language proficiency;
- Legal guardians of paediatric cancer patients able to provide informed consent.
- CAREGIVERS:
- Caregivers and/or family members of cancer patients who lived or assist the loved ones with a current or previous cancer diagnosis in the cancer journey;
- Adequate language proficiency;
- Able to provide informed consent;
- Caregivers and/or family members of paediatric cancer patients under 12 years of age.
Who cannot join
- Healthcare professionals with limited oncology patient contact;
- Insufficient knowledge of the local language;
- Severe cognitive impairment, and/or mental disorders that prohibited their participation in the study or inadequate verbal skills that may render them incapable of informed consent (as evaluated by the clinician);
- Inability to understand the study materials (as evaluated by the clinician);
- Physical or psychological impairment that prohibits their participation in focus groups (as evaluated by the clinician).
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
France1 site, 1 recruiting
- Recruiting
Centre François Baclesse
Caen
Marie Lange, 00390257489731, gabriella.pravettoni@ieo.it
Germany1 site, 1 recruiting
- Not yet recruiting
Saarland University
Homburg
Norbert Graf, +390257489731, norbert.graf@uks.eu
Italy1 site, 1 recruiting
- Not yet recruiting
European Institute of Oncology
Milan, Italy, 20141
Gabriella Pravettoni, +390257489731, gabriella.pravettoni@ieo.it
Lithuania1 site, 1 recruiting
- Not yet recruiting
National Cancer Institute
Vilnius
BRASIUNIENE BIRUTE, 00370 5 2786 729, birute.brasiuniene@nvi.lt
Spain1 site, 1 recruiting
- Not yet recruiting
Catalan Institute of Oncology
Barcelona
Cristian Ochoa Arnedo, 0034 653074311, cochoa@iconcologia.net
About this study
Official title: ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre
The target population includes cancer patients, caregivers, family members, healthcare providers and mental health specialists, who will be the primary end-users of the Althea platform. For patients, survivors, caregivers, and family members, the sample variables include age, gender, type and stage of disease, and time since the first diagnosis. The healthcare professionals that will be involved in this study are those who attend to oncological patients, with sample variables such as age, gender, professional role, and prior experience and training in oncology or psycho-oncology.
- Conditions
- Cancer Diagnosis
- Being tested
- Patients, survivors, caregivers, family members and healthcare professionals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients, survivors, caregivers, family members and healthcare professionalsBehavioural
Focus group discussions (FGD) and completion of survey
| Study group | Role | What they receive |
|---|---|---|
| Patients, survivors, caregivers, family members and healthcare professionals | Experimental | Focus group discussions (FGD) and completion of survey Receives: Behavioral: Patients, survivors, caregivers, family members and healthcare professionals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)
Number of unmet needs reported by patients, caregivers and Health Care Professionals (HCPs)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start14 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416513
- Sponsor's protocol ID
- L2-293
- Acronym
- ALTHEA
- Status last verified
- Feb 2026
- First submitted
- 3 Jun 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre
- ClinicalTrials.gov ID
- NCT07416513
- Acronym / sponsor ID
- ALTHEA / L2-293
- Conditions
- Cancer Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The target population includes cancer patients, caregivers, family members, healthcare providers and mental health specialists, who will be the primary end-users of the Althea platform. For patients, survivors, caregivers, and family members, the sample variables include age, gender, type and stage of disease, and time since the first diagnosis. The healthcare professionals that will be involved in this study are those who attend to oncological patients, with sample variables such as age, gender, professional role, and prior experience and training in oncology or psycho-oncology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients, survivors, caregivers, family members and healthcare professionals | Experimental | Behavioral: Patients, survivors, caregivers, family members and healthcare professionalsFocus group discussions (FGD) and completion of survey |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Healthcare professionals actually working in oncology and/or psychooncology;
- Teachers of paediatric cancer patients.
- Patients with a current or previous cancer diagnosis
- Adequate language proficiency,
- Able to provide informed consent;
Key exclusion criteria (5 listed)
- Healthcare professionals with limited oncology patient contact;
- Insufficient knowledge of the local language;
- Severe cognitive impairment, and/or mental disorders that prohibited their participation in the study or inadequate verbal skills that may render them incapable of informed consent (as evaluated by the clinician);
- Inability to understand the study materials (as evaluated by the clinician);
- Physical or psychological impairment that prohibits their participation in focus groups (as evaluated by the clinician).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients, survivors, caregivers, family members and healthcare professionalsFocus group discussions (FGD) and completion of survey | Behavioural | Patients, survivors, caregivers, family members and healthcare professionals |
Primary outcome
Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)
Time frame: 15 months
Number of unmet needs reported by patients, caregivers and Health Care Professionals (HCPs)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriella Pravettoni, MD principal investigator
European Institute of Oncology
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients, survivors, caregivers, family members and healthcare professionals in people with Cancer Diagnosis, run by European Institute of Oncology at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Italy, Lithuania, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Pravettoni, MD (+390257489731, gabriella.pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs) (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.