Digital Solutions for bEtter cAre
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patients, survivors, caregivers, family members and healthcare professionals.
- Who it may be relevant to
- Registry conditions: Cancer Diagnosis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Germany, Italy, Lithuania, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre
Overview
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
- Behavioral Patients, survivors, caregivers, family members and healthcare professionals
Focus group discussions (FGD) and completion of survey
Primary outcome measures
- Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs) [Time frame: 15 months]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre François Baclesse — Caen
Germany · 1 center
- Saarland University — Homburg
Italy · 1 center
- European Institute of Oncology — Milan
Lithuania · 1 center
- National Cancer Institute — Vilnius
Spain · 1 center
- Catalan Institute of Oncology — Barcelona
Identifiers
NCT: NCT07416513 · L2-293