Clinical trial NCT05365256: Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer
Official title: Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer VIRECAPS2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer of Colon
Virtual Reality
Keywords: virtual reality
Colorectal cancer
Quality of life
Mental Health
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: GCS Ramsay Santé pour l'Enseignement et la Recherche
First posted: 2022-05-09
Enrollment: 98
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: The increase in the survival of cancer patients and the incidence of cancers leads to a rapid increase in the number of people living after a diagnosis of cancer.

Occupation during chemotherapy treatment time has been identified as an excellent way to support cancer patients. Studies show that distraction interventions increase tolerance to treatment, by decreasing the importance given to negative stimuli associated with chemotherapy and increasing pleasurable emotions.

In this context, virtual reality (VR) is a promising intervention for patients receiving chemotherapy. VR is considered a powerful painkiller, even more effective than other distractors, such as movies or video games for example.

Several studies have shown short-term beneficial effects of integrating VR in patients undergoing chemotherapy. This intervention would help patients better adhere to and tolerate treatment. Considering that positive emotions could be one of the underlying processes necessary for the effectiveness of VR, it would be possible to support the cancer patient towards better overall well-being thanks to these new technologies.

Investigators can therefore ask themselves the question of the impact that VR used during chemotherapy can have on the adaptation of patients to the disease and its treatments as well as on their psychological distress in the medium and long term.

Detailed description: The increase in the survival of cancer patients and the incidence of cancers leads to a rapid increase in the number of people living after a diagnosis of cancer. Supporting people during and after treatment is an element of the third Cancer Plan (2014-2019) promoting the emergence of innovations for the benefit of patients as well as the implementation of global and personalized actions of support, and wishing to reduce the impact of cancer on personal life.

Occupation during chemotherapy treatment time has been identified as an excellent way to support cancer patients. Studies show that distraction interventions (progressive relaxation, guided imagery, cognitive distractions such as reading, humor, listening to music, watching a movie, etc.) increase tolerance to treatment, by decreasing the importance given to negative stimuli associated with chemotherapy and increasing pleasurable emotions.

In this context, virtual reality (VR) is a promising intervention for patients receiving chemotherapy. It makes it possible to modulate the attentional and emotional processes responsible for physiological and psychic reactions (pain, psychological distress, anxiety). VR is considered a powerful painkiller, even more effective than other distractors, such as movies or video games for example.

Several studies have shown short-term beneficial effects of integrating VR in patients undergoing chemotherapy. This intervention would help patients better adhere to and tolerate treatment. Considering that positive emotions could be one of the underlying processes necessary for the effectiveness of VR, it would be possible to support the cancer patient towards better overall well-being thanks to these new technologies.

Investigators can therefore ask themselves the question of the impact that VR used during chemotherapy can have on the adaptation of patients to the disease and its treatments as well as on their psychological distress in the medium and long term.

Eligibility criteria: Inclusion Criteria:

* Male or female, over 18 years of age.
* Patient with colorectal cancer treated with adjuvant chemotherapy.
* Chemotherapy naïve patient
* Patient speaking and understanding French and able to complete the questionnaires.
* Affiliated patient or beneficiary of a social security scheme.
* Patient having been informed of the research and having signed a free and informed consent

Exclusion Criteria:

* Patient participating in another clinical study
* Patient with a history or progressive psychiatric illness
* Patient with severe visual and hearing impairment
* Patient not supporting the wearing of the virtual reality headset
* Patient who is unable to undergo medical monitoring for geographical, social or psychological reasons
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient women

Primary outcomes:
measure: Level of psychological well-being
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guilherand-Granges
country: France
facility: Hôpital Privé Drôme Ardèche
state: Aura
Study officials:
affiliation: Ramsay Santé - Hôpital Privé Drôme
name: Sophie Lantheaume, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banos RM, Espinoza M, Garcia-Palacios A, Cervera JM, Esquerdo G, Barrajon E, Botella C. A positive psychological intervention using virtual reality for patients with advanced cancer in a hospital setting: a pilot study to assess feasibility. Support Care Cancer. 2013 Jan;21(1):263-70. doi: 10.1007/s00520-012-1520-x. Epub 2012 Jun 13.
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citation: Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
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citation: Schneider SM, Hood LE. Virtual reality: a distraction intervention for chemotherapy. Oncol Nurs Forum. 2007 Jan;34(1):39-46. doi: 10.1188/07.ONF.39-46.
citation: Tugade MM, Fredrickson BL, Barrett LF. Psychological resilience and positive emotional granularity: examining the benefits of positive emotions on coping and health. J Pers. 2004 Dec;72(6):1161-90. doi: 10.1111/j.1467-6494.2004.00294.x.