Mental HealthALTHEANCT07691281
Disparities in Mental Health Screening and Support
An observational study of Mental Health and Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
To develop and administer online surveys to cancer patients and their families across diverse regions within the EU to detect possible disparities in their access to mental health screening and psychological-cognitive support Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Cancer
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 30 Dec 2026
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cancer patients (both adult and paediatric) and their family members\caregivers living in EU.
Who may be able to join
- residence in EU
- internet access
- access to a technological device for survey participation
- individuals at all cancer stages who have been diagnosed with cancer, are currently undergoing treatment or have survived cancer
- ability to understand and the willingness to sign a written informed consent document
- residence in EU
Show all 10Show fewer
- internet access
- access to a technological device for survey participation
- individuals that are aged 18 or older who currently provide, or have provided, care, psychosocial and physical support for a cancer patient in the EU
- ability to understand and the willingness to sign a written informed consent document
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology, Milan
Milan, Mi, 20141
Gabriella Pravettoni, PhD, +39 0257489207, Gabriella.Pravettoni@ieo.it
Ilaria Durosini, PhD, +39 0257489207, ilaria.durosini@ieo.it
About this study
Official title: ALTHEA - tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre Work Package 3: Disparities in Mental Health Screening and Support
To develop and administer online surveys to cancer patients and their families across diverse regions within the EU to detect possible disparities in their access to mental health screening and psychological-cognitive support
Read the detailed description
In order to detect possible disparities in the access to mental health screening and psychological-cognitive support, cancer patients and survivors will be involved. A minimum of 1000 patients will be surveyed to gather insights on their experiences with mental health screening, the support they received, and perceived barriers and facilitators in accessing mental health services. Similarly, caregivers and/or family members of cancer patients will be invited to participate in this study. At least 1000 family members and caregivers who support cancer patients will also be surveyed to understand their mental health needs and the challenges they encounter in seeking support for themselves and for patients. For these surveys, individuals at all cancer stages who have been diagnosed with cancer, are currently undergoing treatment or have survived cancer will be invited to participate. Participants must reside in the EU, have Internet access and can use a technological device for survey participation.
Considering the pediatric population, the following inclusion criteria will be adopted:
- Pediatric cancer patients 12-17 years, responding on behalf of themselves;
- caregivers of pediatric cancer patients (0-11 y), responding on behalf of their child and themselves;
- caregivers of pediatric cancer patients (12+ y), responding only on behalf of themselves.
Regarding caregivers and family members, the investigators will include individuals that are aged 18 or older who currently provide, or have provided, care, psychosocial and physical support for a cancer patient in the EU. As with patients, caregivers and family members should also have access to the internet and at least one technological device.
- Conditions
- Mental Health, Cancer
- Keywords
- mental health disparities, cancer care, psychoncology
- Medical subject headings
- Psychological Well-Being, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult cancer patients | Individuals aged 18 years or older at all cancer stages, who have been diagnosed with cancer, are currently undergoing treatment or have survived cancer | |
| Caregivers of adult cancer patients | individuals that are aged 18 or older who currently provide, or have provided, care, psychosocial and physical support for an adult cancer patient | |
| Paediatric cancer patients | Pediatric cancer patients 12-17 years, responding on behalf of themselves | |
| caregivers of pediatric cancer patients (0-11y) | Family members and caregivers of patients between 0-11 years old, responding on behalf of their child and themselves | |
| caregivers of pediatric cancer patients (12+ y) | Family members and caregivers of patients between 12-17 years old responding only on behalf of themselves |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disparities in access to mental health
Number of participants who experienced disparities in the access to and provision of mental health services, how frequently EU countries have encountered these disparities, and detection of the principal barriers and facilitators through thematic analysis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Sep 2026
- Primary completion15 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català d'Oncologia, Hospital Sant Joan de Deu, ORGANISATION OF EUROPEAN CANCER INSTITUTES, Vilnius University Hospital Santaros Klinikos, Universität des Saarlandes, SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI, World Against Cancer Foundation, The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca, INSTITUT ZA GASTROENTEROLOSKE TUMORE IGET, STATE INSTITUTION NATIONAL SCIENTIFIC CENTER THE M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, CLINICAL AND REGENERATIVE MEDICINE OF THE NATIONAL ACADEMY OF MEDICAL
- Responsible party
- Sponsor
- Investigators
- Gabriella Pravettoni, PhD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691281
- Sponsor's protocol ID
- UID 5350
- Other IDs
- L2-587
- Acronym
- ALTHEA
- Status last verified
- Sep 2026
- First submitted
- 15 Jun 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 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 Work Package 3: Disparities in Mental Health Screening and Support
- ClinicalTrials.gov ID
- NCT07691281
- Acronym / sponsor ID
- ALTHEA / UID 5350
- Conditions
- Mental Health, Cancer
- Keywords
- mental health disparities, cancer care, psychoncology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Institut Català d'Oncologia, Hospital Sant Joan de Deu, ORGANISATION OF EUROPEAN CANCER INSTITUTES, Vilnius University Hospital Santaros Klinikos, Universität des Saarlandes, SDRUZHENIE ASOTSIATSIA NA PATSIENTITE SONKOLOGICHNI ZABOLYAVANIA I PRIYATELI, World Against Cancer Foundation, The Oncology Institute "Prof. Dr. Ion Chiricuţă" Cluj-Napoca, INSTITUT ZA GASTROENTEROLOSKE TUMORE IGET, STATE INSTITUTION NATIONAL SCIENTIFIC CENTER THE M.D. STRAZHESKO INSTITUTE OF CARDIOLOGY, CLINICAL AND REGENERATIVE MEDICINE OF THE NATIONAL ACADEMY OF MEDICAL
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Jul 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.
To develop and administer online surveys to cancer patients and their families across diverse regions within the EU to detect possible disparities in their access to mental health screening and psychological-cognitive support
Detailed description
In order to detect possible disparities in the access to mental health screening and psychological-cognitive support, cancer patients and survivors will be involved. A minimum of 1000 patients will be surveyed to gather insights on their experiences with mental health screening, the support they received, and perceived barriers and facilitators in accessing mental health services. Similarly, caregivers and/or family members of cancer patients will be invited to participate in this study. At least 1000 family members and caregivers who support cancer patients will also be surveyed to understand their mental health needs and the challenges they encounter in seeking support for themselves and for patients. For these surveys, individuals at all cancer stages who have been diagnosed with cancer, are currently undergoing treatment or have survived cancer will be invited to participate. Participants must reside in the EU, have Internet access and can use a technological device for survey participation.
Considering the pediatric population, the following inclusion criteria will be adopted:
- Pediatric cancer patients 12-17 years, responding on behalf of themselves;
- caregivers of pediatric cancer patients (0-11 y), responding on behalf of their child and themselves;
- caregivers of pediatric cancer patients (12+ y), responding only on behalf of themselves.
Regarding caregivers and family members, the investigators will include individuals that are aged 18 or older who currently provide, or have provided, care, psychosocial and physical support for a cancer patient in the EU. As with patients, caregivers and family members should also have access to the internet and at least one technological device.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| adult cancer patients | – | –Individuals aged 18 years or older at all cancer stages, who have been diagnosed with cancer, are currently undergoing treatment or have survived cancer |
| Caregivers of adult cancer patients | – | –individuals that are aged 18 or older who currently provide, or have provided, care, psychosocial and physical support for an adult cancer patient |
| Paediatric cancer patients | – | –Pediatric cancer patients 12-17 years, responding on behalf of themselves |
| caregivers of pediatric cancer patients (0-11y) | – | –Family members and caregivers of patients between 0-11 years old, responding on behalf of their child and themselves |
| caregivers of pediatric cancer patients (12+ y) | – | –Family members and caregivers of patients between 12-17 years old responding only on behalf of themselves |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients (both adult and paediatric) and their family members\caregivers living in EU.
Key inclusion criteria (10 listed)
- residence in EU
- internet access
- access to a technological device for survey participation
- individuals at all cancer stages who have been diagnosed with cancer, are currently undergoing treatment or have survived cancer
- ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disparities in access to mental health
Time frame: through study completion, an average of 1 year
Number of participants who experienced disparities in the access to and provision of mental health services, how frequently EU countries have encountered these disparities, and detection of the principal barriers and facilitators through thematic analysis
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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, PhD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health and Cancer, run by European Institute of Oncology at 1 site in Italy.
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 10 inclusion and 1 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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, PhD (+39 0257489207, Gabriella.Pravettoni@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disparities in access to mental health (time frame: through study completion, an average of 1 year). 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 10 Sep 2026.