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Benefits of cinEmA Sessions During Radio-chemoTherapy on Outcomes of Patients With ceRvIcal canCEr

Benefits of cinEmA Sessions During Radio-chemoTherapy on Outcomes of Patients With ceRvIcal canCEr

Recruiting
18-70 years
Female
Phase N/A

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Overview

The BEATRICE (Benefits of cinEmA Sessions During Radio-chemoTherapy on Outcomes of Patients With ceRvIcal canCEr) study protocol aims to explore the psychological and medical benefits of cinema therapy during chemotherapy sessions for cervical cancer patients undergoing radiochemotherapy (RTCT). The study builds on prior research indicating the efficacy of art-based and immersive interventions, such as virtual reality, in reducing anxiety, distress and body symptoms in oncology patients. With a focus on personalizing cancer care, this study utilizes an immersive multimedia room where patients weekly can watch curated films during chemotherapy sessions. Endpoints include psychological outcomes, such as state anxiety, quality of life, and affective states, body perceptions, as well as medical outcomes, such as perceived treatment duration, salivary alpha-amylase levels (a stress biomarker), and clinical responses over time.

This randomized controlled trial spans 24 months, including recruitment, data collection, and analysis. Patients are assessed at three timepoints: before, immediately after, and seven days post-chemotherapy infusion, using validated psychological and quality-of-life measures. Salivary samples will also be analyzed to evaluate stress levels before and immediately after chemotherapy.

The BEATRICE study integrates technological and artistic innovation into patient care, aligning with a broader movement towards empathetic and uplifting oncology practices.

Eligibility

Inclusion Criteria:

  • Patients' age ≥ 18 years
  • Patients able to understand and sign informed consent
  • Confirmed histological diagnosis of cervical cancer
  • ECOG 0-2

Exclusion Criteria:

  • Patients' age \> 70 years
  • Patients with inability to express informed consent
  • Patients denying informed consent
  • Patients with psychopathological disturbances preexisting to the cancer diagnosis
  • Patients affected by visual disturbances that prevent them from watching a movie
  • Patients under beta blockers or sympathomimetic therapies

Study details
    Cervical Cancer

NCT07902180

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

31 October 2026

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