Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer

Virtual Reality Clinical Trial

— VIRECAPS2  

Official title:

Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer VIRECAPS2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365256
• Other study ID #: 2021-A02382-39
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2022
• Source: Ramsay Générale de Santé
• Contact: JF oudet
• Phone: 683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer of Colon
• Colonic Neoplasms
• Colorectal Neoplasms
• Virtual Reality

Intervention

Behavioral:
• Standard distraction during chemotherapy treatment period
habitual distraction of patients during chemotherapy sessions authorized as part of routine care
• Virtual distraction during chemotherapy treatment period
A virtual reality headset will be worn for 15 minutes per hour of treatment

Locations

Country	Name	City	State
France	Hôpital Privé Drôme Ardèche	Guilherand-Granges	Aura

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

References & Publications (8)

Bani Mohammad E, Ahmad M. Virtual reality as a distraction technique for pain and anxiety among patients with breast cancer: A randomized control trial. Palliat Support Care. 2019 Feb;17(1):29-34. doi: 10.1017/S1478951518000639. Epub 2018 Sep 10. — View Citation

Baños RM, Espinoza M, García-Palacios A, Cervera JM, Esquerdo G, Barrajón 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 — View Citation

Chirico A, Lucidi F, De Laurentiis M, Milanese C, Napoli A, Giordano A. Virtual Reality in Health System: Beyond Entertainment. A Mini-Review on the Efficacy of VR During Cancer Treatment. J Cell Physiol. 2016 Feb;231(2):275-87. doi: 10.1002/jcp.25117. Re — View Citation

Cohn MA, Fredrickson BL, Brown SL, Mikels JA, Conway AM. Happiness unpacked: positive emotions increase life satisfaction by building resilience. Emotion. 2009 Jun;9(3):361-8. doi: 10.1037/a0015952. — View 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/A — View Citation

Schneider SM, Hood LE. Virtual reality: a distraction intervention for chemotherapy. Oncol Nurs Forum. 2007 Jan;34(1):39-46. — View Citation

Schneider SM, Kisby CK, Flint EP. Effect of virtual reality on time perception in patients receiving chemotherapy. Support Care Cancer. 2011 Apr;19(4):555-64. doi: 10.1007/s00520-010-0852-7. Epub 2010 Mar 26. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of psychological well-being	Total score from WEMWBS scale	6 months