ALTHEA: tAckLing menTal Health Cancer Patients and Their Families: Digital Solutions for bEtter cAre
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Number of unmet needs of patients, caregivers and Health Care Professionals (HCPs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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).
Arms & Interventions
Patients, survivors, caregivers, family members and healthcare professionals
Focus group discussions (FGD) and completion of survey
Intervention: Patients, survivors, caregivers, family members and healthcare professionals (Behavioral)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported