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

Condition(s) studied

Investigational drug(s) / intervention(s)

cinema session: Patients will undergo their chemotherapy infusion while comfortably seated in the multimedia room, where they can enjoy visual experiences closely resembling those of a cinema.

Study summary

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

Primary outcome measure(s)

• effect of cinema on anxiety — 1 week
  To evaluate if there is a difference in state anxiety between the EG (cinema) group and the TAU (treatment as usual) measured by STAI in Y1 form for the State Anxiety (State Trait Anxiety Inventory) - range score 20 - 80. Higher scores mean worse outcome.

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy

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