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

NCT06468293 | Recruiting

• 1 other identifier: IEO 1702
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control group

NO INTERVENTION

Non psychological support intervention

Intervention group

OTHER

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

Other: Psychological support

Interventions

Psychological support OTHER

Psychological support intervention

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Gabriella Pravettoni

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

+390257489731; gabriella.pravettoni@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: June 21, 2024
• Study Start: October 8, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-03

Locations

IT (1)