Clinical trial NCT04528238: Impact of Relaxing Visual Immersion on Anxiety During Anti-cancer Treatment.
Official title: Multicentric, Randomized, Open-label Study to Assess the Impact of Relaxing Visual Immersion (RVI) on Reducing Anxiety During Intravenous Cancer Treatment in Cancer Patients.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Since the 60's and 70's, the soar of audiovisual technologies allowed the development of virtual reality (VR). These technologies were then adapted to help reducing anxiety and pain during medical procedures. For visual or audio stimulation, the use of glasses or helmet is frequent. However, little is know about the efficacy of technologies which are not isolating the patient from his real environment during medical care. With this study, the investigators will assess the impact of this kind of sensitive stimulation without isolating the patient, on reducing the anxiety during intravenous treatment in patients with cancer. The machine the investigators are using is projecting relaxing nature movies on the ceiling of the room, with nature sounds or relaxing music.

Detailed description: The diagnosis of cancer and the treatments used may be the cause, for the patient, of a significant emotional and psychological anxiety. For many years, several studies have evaluated the impact of visual and sensitive techniques on the well-being of the patient: landscaping of gardens,use of positive distraction means (decoration, brightness of spaces, photographs, layout of natural scenes, aquarium installation, etc.). The objective of these studies was to give to the patient a contact with nature reinforcing the positive emotions and reducing stress.

A randomized study including 37 patients who will undergo flexible sigmoidoscopy of diagnosis, to receive during the intervention, audio stimulation, audio and visual stimulation by glasses (Virtual IO, 1000 Leonora), or no stimulation. Audio and visual stimulation reduced abdominal discomfort (measured using visual analog scale VAS) and a decrease in anxiety (measured by the Stress Symptom Ratings scale) compared to the group without stimulation (p \<0.05), but without solid evidence given the small number of patients with an imprecise randomization.

Other distraction systems using paintings of nature scenes combined with a listening to the sounds of nature were used during bronchoscopy: 80 patients were randomized (distraction systems versus control group without stimulation): the decrease in pain (rated on a 5-point scale from poor to excellent) was significantly greater in the intervention versus control group (p \<0.015). There was no significant effect on anxiety measured by the S-STAI scale compared to the control group (with a 6 point difference between groups). Another Chinese prospective randomized controlled trial (Lee et al. 2004), conducted on 165 patients, has shown that visual and audio distraction (by Eyetrek system, Olympus) could reduce the need for sedatives used during colonoscopy compared to the group with visual distraction only and in the distraction-free control group (p \<0.01). From the years 1960-1970, the development of digital audiovisual technologies allowed to develop virtual reality techniques. The term "virtual reality" (VR) refers to a computer technology that simulates artificially the user's environment, with which the user can interact. In oncology, virtual reality (VR) techniques have been used in 3 situations :

- during painful procedures: A randomized controlled study conducted on 30 adolescents with cancer who will undergo a lumbar puncture, analyzed the impact of VR glasses on pain assessed by VAS and the feedback of the patients. There was no statistically significant difference between 2 groups but pain scores were lower in the VR group (The mean VAS in the VR group was 7 points with a range ranging from 0 to 48 while in the control group the average was 9 points with a range from 0 to 59).

Another randomized study conducted on 59 children with cancer whose treatments required access to a subcutaneous venous device assessed the value of VR distraction, non-virtual distraction and the absence of distraction. Reductions in pain and anxiety have been observed (measured by VAS) in children using VR distraction but were not significant given the small sample size. However the reduction of the heart rate was significant in the VR distraction group (p \<0.05).

- during hospitalization: This situation is considered stressful because it is linked to a change in the state of health and because it introduces stressful conditions like lack of autonomy, privacy, etc.

A study showed on 19 hospitalized patients with metastatic cancer, exposed to 4 sessions of 30 minutes for 1 week with a VR headset, an increase in joy over the 4 sessions (before and after the test, p \<0.009) and a decrease in sadness over the 2nd session (before and after the test, p \<0.003).

Another study showed on 33 hospitalized patients with metastatic cancer under the same conditions as the Banos study, an increase in positive emotions and a decrease in negative emotions after each session (p \<0.05).

- during the chemotherapy infusion to reduce the symptoms related to the treatment or disease: A study evaluated the interest of VR by head-mounted display (Sony PC Glasstron PLM-S700) in 16 women aged 50 years and older during chemotherapy infusions. The symptoms such as anxiety and fatigue were assessed (STAI scale and revised Piper scale PFS). Patients were randomized to 2 chemotherapy sessions with the use of VR head-mounted display for one session and without stimulation for the other session. A decrease in anxiety immediately after the session was shown in this small number of patients (p = 0.10). On the other hand, there was no difference for fatigue but the study was carried out only on one session of RV.

It was showed a benefit of VR in 123 patients with breast, lung or colon cancer, receiving 2 chemotherapy sessions: participants were randomized according to a cross-over design in order to receive the VR intervention (by i-Glasses SVGA HeadMounted Display helmet) during one chemotherapy session and to receive during the other session no VR intervention (control arm), each patient being their own control. This technique was using a laptop, VR headset, and software. The Symptom Distress Scale was used to assess symptoms of distress immediately after the session and 48 hours after the session. No significant difference was found for the symptoms of distress between the session receiving the VR intervention and the session not receiving the intervention of VR. However, the study only assessed the use of VR over a single treatment session. The patients who received the VR technique had a decrease in anxiety during the initial session of chemotherapy (decrease of 3.34 points, p = 0.01). In addition, the perception of the time during the chemotherapy session was significantly altered, making the session more tolerable because it is shorter and thus validating the distraction capacity of this intervention.

When it comes to physical variables (vital signs), 4 studies found a significant difference in heart rate with a lower rate in the Virtual Reality group.

However, few studies in oncology have looked at non-isolating devices for VR (without helmet or glasses), therefore without excluding the patient from his environment. This non-isolating technology has also been considered as being able to offer the patient a more secure environment.

The purpose of this study is to assess the impact of this kind of stimulation during the intravenous treatment in patients with cancer.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 and over.
* Patient with cancer (any location) who need to receive an intravenous (IV) cancer treatment (adjuvant, neoadjuvant or palliative) when taking initial disease burden or upon relapse (the IV treatments concomitant with radiotherapy are also possible).
* Patients scheduled for at least 3 consecutive sessions of IV anti-cancer treatment.
* Patient under health insurance plan.
* Information and signature of informed consent by the patient to participate in the study.

Exclusion Criteria:

* Pregnant women.
* Vulnerable patient (psychiatric illness, detainee, under legal protection, emancipated child).

Primary outcomes:
measure: Assess the impact of RVI on anxiety during the first intravenous cancer treatment session in cancer patients treated or not by anxiolytics
timeFrame: Baseline : first visit for intravenous anti-cancer treatment.
Secondary outcomes:
measure: Assessment of pain felt.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of asthenia.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of nausea.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of psychological distress.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of the perception of elapsed time.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of the quality of patient - caregiver communication.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of the vital signs.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of the vital signs.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of the undesirable effects linked to the RVI.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of the anxiety.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Analysis of the taking anti-anxiety treatments during anti-cancer treatment session
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
measure: Assessment of the quality of life.
timeFrame: Up to 2 years, during 3 anti-cancer treatment sessions.
Other outcomes:
Locations:
Study officials:
References:
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