Breast Cancer, Pelvic Cancer
Conditions
Brief summary
In France, according to the National Cancer Institute, it appears that treatments in radiotherapy centers for cancer will increase from 198,000 in 2015 to 239,000 in 2030: this represents 40,000 additional treatments in 15 years. A meta-analysis on radiotherapy indicated that 10 to 20% of patients had clinically significant levels of anxiety at the beginning of radiotherapy. Indeed, several factors generate this tension, above all the new or unfamiliar environment, the imposing and noisy scanner, the restraints that are difficult to bear or the nudity required for the examination. This anxiety has an impact on performance of the planning CT scan examination, an essential step for the future treatment. The radiotherapy unit of the Centre Hospitalier Departemental de Vendee has put in place resources to reduce anxiety felt during treatment sessions (music therapy, conversational hypnosis, sophrology or aromatherapy). However, nothing has been put in place to reduce the anxiety of patients in the period preceding the planning CT scan. Virtual reality software seems to be a good alternative that requires fewer human resources. The research hypothesis is that patients who have benefited from the virtual reality software will have a lower level of anxiety before the planning CT scan than patients who have not benefited from virtual reality.
Interventions
DEVICEVirtual reality software
The patient will undergo a 20-minute virtual reality session before the planning CT scan
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Patient with an indication for first radiotherapy treatment for breast or pelvic cancer (prostate, rectum, endometrium, anal canal and cervix) 2. Patient ≥ 18 years old, 3. Patient who has the capacity to understand the protocol and has given written consent to participate in the research, 4. Patient with social security coverage.
Exclusion criteria
1. Metastatic patients 2. Patients with previous radiotherapy 3. Patients with a diagnosis of hearing impairment 4. Patients with major cognitive disorders (such as dementia) 5. Psychiatric pathology such as schizophrenia 6. Patients with epilepsy or hypersensitivity to flashing lights 7. Patient with a pacemaker, hearing aid or defibrillator 8. Claustrophobic patients 9. Patients sensitive to motion sickness 10. Patients who are visually impaired or blind 11. Patients with migraine 12. Patients with skin defects and open wounds in the area where the helmet is applied (face or scalp) or in the eyes 13. Patients under guardianship, curators or deprived of liberty 14. Non French speaking patient 15. Illiterate patient 16. Patient participating in another clinical investigation or interventional clinical research protocol involving a drug 17. Pregnant or breastfeeding patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the Anxiety of the Patient Benefiting From a Virtual Reality Session Versus Normal Care Management | 10 minute before the planning CT scan | Anxiety level measured by the State Anxiety Scale of Spielberger. The scale is a validated 20 item self report assessment device. The score range is 20-80, the higher score indicating anxiety. The cut point of 39-40 has been suggested to detect clinically significant symptoms for the State Anxiety scale. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORVanessa ZINZONI
vanessa.zinzoni@ght85.fr
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 12 |
| BMI | 26.2 kg/m² STANDARD_DEVIATION 5 |
| Cancer type Breast cancer | 64 Participants |
| Cancer type Pelvis cancer | 64 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 72 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 122 |
| other Total, other adverse events | 1 / 120 | 1 / 122 |
| serious Total, serious adverse events | 0 / 120 | 0 / 122 |
Outcome results
None listed