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Digital Solutions for bEtter cAre

ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07416513
Acronym
ALTHEA
Enrollment
200
Registered
2026-02-18
Start date
2025-05-14
Completion date
2026-12-31
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Diagnosis

Brief 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. 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.

Interventions

BEHAVIORALPatients, survivors, caregivers, family members and healthcare professionals

Focus group discussions (FGD) and completion of survey

Sponsors

European Institute of Oncology
Lead SponsorOTHER
European Union
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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, * 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.

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)15 monthsNumber of unmet needs reported by patients, caregivers and Health Care Professionals (HCPs)

Countries

France, Germany, Italy, Lithuania, Spain

Contacts

CONTACTGabriella Pravettoni, MD
gabriella.pravettoni@ieo.it+390257489731
PRINCIPAL_INVESTIGATORGabriella Pravettoni, MD

European Institute of Oncology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026