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

E

European Institute of Oncology

Status

Enrolling

Conditions

Cancer

Treatments

Other: Psychological support

Study type

Interventional

Funder types

Other

Identifiers

NCT06468293
IEO 1702

Details and patient eligibility

About

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.

Full 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.

Enrollment

102 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

102 participants in 2 patient groups

Control group
No Intervention group
Description:
Non psychological support intervention
Intervention group
Other group
Description:
Psychological support intervention with scheduled appointment within the period of diagnostic assessment
Treatment:
Other: Psychological support

Trial contacts and locations

1

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Central trial contact

Gabriella Pravettoni

Data sourced from clinicaltrials.gov

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