Cervical CancerBEATRICENCT07902180
Benefits of cinEmA Sessions During Radio-chemoTherapy on Outcomes of Patients With ceRvIcal canCEr
A study testing cinema session in people with Cervical Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- cinema session
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients' age ≥ 18 years
- Patients able to understand and sign informed consent
- Confirmed histological diagnosis of cervical cancer
- ECOG 0-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Loredana Dinapoli, loredana.dinapoli@policlinicogemelli.it
Loredana Dinapoli
About this study
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.
- Conditions
- Cervical Cancer
- Being tested
- cinema session
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinema sessionOther
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 group | Role | What they receive |
|---|---|---|
| chemiotherapy at cinema | Experimental | patients undergoing cinema sessions during chemotherapy delivery Receives: Other: cinema session |
| chemotherapy as usual | No intervention | patients undergoing standard chemotherapy delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (2)
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.
Measured: 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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Jun 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loredana Dinapoli, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902180
- Sponsor's protocol ID
- 7717
- Acronym
- BEATRICE
- Status last verified
- May 2026
- First submitted
- 26 Sep 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of cinEmA Sessions During Radio-chemoTherapy on Outcomes of Patients With ceRvIcal canCEr
- ClinicalTrials.gov ID
- NCT07902180
- Acronym / sponsor ID
- BEATRICE / 7717
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chemiotherapy at cinema | Experimental | Other: cinema sessionpatients undergoing cinema sessions during chemotherapy delivery |
| chemotherapy as usual | No intervention | –patients undergoing standard chemotherapy delivery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients' age ≥ 18 years
- Patients able to understand and sign informed consent
- Confirmed histological diagnosis of cervical cancer
- ECOG 0-2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cinema sessionPatients will undergo their chemotherapy infusion while comfortably seated in the multimedia room, where they can enjoy visual experiences closely resembling those of a cinema. | Other | chemiotherapy at cinema |
Primary outcome
effect of cinema on anxiety
Time frame: 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.
2 secondary outcomes
Quality of life outcomes
Time frame: 1 week
Salivary alpha-amylase (sAA)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Loredana Dinapoli, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cinema session in people with Cervical Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loredana Dinapoli, PhD (+390630154428, loredana.dinapoli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of cinema on anxiety (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.