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Trial Title:
Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer
NCT ID:
NCT06468293
Condition:
Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Psychological support
Description:
Psychological support intervention
Arm group label:
Intervention group
Summary:
The following randomized longitudinal study will evaluate the long term impact of
caregivers' involvement in cancer care pathway, including a psychological support
intervention on the dyads to be delivered after the detection of a suspected cancer and
before the visit with the oncologist for discussing therapeutic options.
Detailed description:
The following randomized longitudinal study will evaluate the long term impact of
caregivers' involvement in cancer care pathway, including a psychological support
intervention on the dyads to be delivered after the detection of a suspected cancer and
before the visit with the oncologist for discussing therapeutic options. Moreover, a
battery of self-report questionnaires will be administered, and sociodemographic and
clinical data will be collected. The time window in which to deliver the support
intervention is after the detection of a suspected cancer and before the visit with the
oncologist, at the time when the patient undergoes diagnostic exams (to understand the
type of tumor he/she is affected by), and the most suitable therapeutic protocol have to
be discussed with the oncologist.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Gabriella Pravettoni
Start date:
October 8, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
European Institute of Oncology
Agency class:
Other
Source:
European Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06468293
