Role of Caregiver in the Clinical Pathway of Patients With Breast and Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-08

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

Non psychological support intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Psychological support intervention with scheduled appointment within the period of diagnostic assessment

Group Type OTHER

Psychological support

Intervention Type OTHER

Psychological support intervention

Interventions

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Psychological support

Psychological support intervention

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes