An interventional study of cinema session in Cervical Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Supportive care
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 68 is below the median of 100 across 1,738 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients undergoing cinema sessions during chemotherapy delivery
Other: cinema session
patients undergoing standard chemotherapy delivery
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.
effect of cinema on anxiety
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.
Time frame: 1 week
Quality of life outcomes
Quality of life and psychological profile were assessed with the EORTC QLQ-C30, its cervical cancer module QLQ-CX24 and the PANAS (positive and negative emotions). C30 and CX24 items are scored 1-4 (C30 items 29-30: 1-7) and transformed to 0-100: higher scores indicate better global QoL and functioning (incl. CX24 sexual activity and enjoyment) but a greater burden on symptom scales (e.g. fatigue, pain; CX24 symptom experience, body image, sexual/vaginal functioning). CX24 sexual items apply only to sexually active women. The PANAS has two 10-item subscales, positive and negative affect, each scored 10-50; higher scores indicate greater affect.
Time frame: 1 week
Salivary alpha-amylase (sAA)
Salivary alpha-amylase (sAA), a marker of sympathetic stress activation, will be measured in U/mL at standardised times (no fixed range; higher values = greater activation).
Time frame: 1 day
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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