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

Cancer Clinical Trial

Official title:

The Role of Caregiver in the Clinical Pathway of Patients Newly Diagnosed With Breast and Prostate Cancer: a Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06468293
• Other study ID #: IEO 1702
• Status: Recruiting
• Phase: N/A
• Start date: October 8, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Gabriella Pravettoni
• Phone: +390257489731
• Email: gabriella.pravettoni[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 102
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Prostatic Neoplasms

Intervention

Other:
• Psychological support
Psychological support intervention

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the compliance with therapy	The primary endpoint of this study is to observe a difference of 3 points in the average values of the "Interpersonal aspect of care" and "Subjective norm" subscales of the Adherence Determination Questionnaire (ADQ), in favor of the intervention group.; Response options for each item formed a 5-point Likert scale (1 = strongly disagree; 2 = disagree; 3 = neither agree nor disagree; 4 = agree; 5 = strongly agree). The ADQ questionnaire contains 38 questions, with items 15 and 17 through 24 specifically phrased for patients who have cancer	6 months