Impact of Caregivers on Cancer Patients' Treatment Pathways
The Role of Caregiver in the Clinical Pathway of Patients Newly Diagnosed With Breast and Prostate Cancer: a Randomized Study
This study tests if having caregivers involved in the early treatment process helps people with breast or prostate cancer feel better and have a smoother experience before seeing their doctor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06468293 on ClinicalTrials.gov |
What this trial studies
This randomized longitudinal study evaluates the long-term effects of caregiver involvement in the cancer care pathway for patients diagnosed with breast or prostate cancer. It includes a psychological support intervention aimed at both patients and their caregivers, delivered after a suspected cancer diagnosis and prior to the oncologist consultation. Participants will complete self-report questionnaires, and sociodemographic and clinical data will be collected to assess the intervention's impact on the care experience. The study focuses on early-stage cancer patients who have not yet discussed treatment options with their oncologist.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have recently received a diagnosis of early-stage breast or prostate cancer.
Not a fit: Patients with advanced-stage cancer or those with pre-existing mental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the emotional and psychological support for cancer patients and their caregivers, potentially improving treatment outcomes.
How similar studies have performed: Other studies have shown positive outcomes with caregiver involvement in cancer care, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient: * Patient aged ≥18 years at the time of recruitment. * Patients who have just received a cancer diagnosis and have yet to discuss with their oncologist the treatment to undergo after diagnosis of breast or prostate cancer. * Early-stage cancer (I or II). Caregiver: * Age ≥ 18 at the time of recruitment. * Taking care of the patient. Exclusion Criteria: Patients: * Presence of early mental disorders (before age 40) or severe neurological disorder. * Patients with advanced stage cancer for which the path is already defined (palliative care patients). Caregivers: ● Presence of early mental disorders (before age 40) or severe neurological disorder.
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Gabriella Pravettoni — European Institute of Oncology
- Study coordinator: Gabriella Pravettoni
- Email: gabriella.pravettoni@ieo.it
- Phone: +390257489731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.