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Recruiting

NCT Number: NCT07416513

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.

Recruiting

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Key information

Conditions

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre François Baclesse, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Patients, survivors, caregivers, family members and healthcare professionals

Behavioral

Focus group discussions (FGD) and completion of survey

Primary outcomes

  1. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriella Pravettoni, MD

CONTACT

[email protected]

+390257489731

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Collaborators

  • European Union

Registry information

Official study title

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

Acronym: ALTHEA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2026
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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