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

NCT05365256 | Unknown

• 1 other identifier: 2021-A02382-39
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Colon; Virtual Reality

Keywords

virtual reality; Colorectal cancer; Quality of life; Mental Health

Outcome Measures

Primary Outcomes (1)

• Level of psychological well-being

  Total score from WEMWBS scale

  6 months

Study Arms (2)

Standard time occupation of treatment period

ACTIVE COMPARATOR

habitual distraction of patients during chemotherapy sessions authorized as part of routine care (doing nothing, discussion, reading, games, etc.).

Behavioral: Standard distraction during chemotherapy treatment period

time occupation of treatment period by virtual reality

EXPERIMENTAL

Use of virtual reality as a distraction during chemotherapy sessions. A virtual reality headset will be worn for 15 minutes per hour of treatment (with a maximum of three sessions per cycle of chemotherapy)

Behavioral: Virtual distraction during chemotherapy treatment period

Interventions

Standard distraction during chemotherapy treatment period BEHAVIORAL

habitual distraction of patients during chemotherapy sessions authorized as part of routine care

Standard time occupation of treatment period

Virtual distraction during chemotherapy treatment period BEHAVIORAL

A virtual reality headset will be worn for 15 minutes per hour of treatment

time occupation of treatment period by virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• GCS Ramsay Santé pour l'Enseignement et la Recherche: collaborator

Study Sites (1)

Hôpital Privé Drôme Ardèche

Guilherand-Granges, AURA, 07500, France

RECRUITING

Related Publications (8)

• 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.

  PMID: 22688373 RESULT

• 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.

  PMID: 26238976 RESULT

• 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.

  PMID: 19485613 RESULT

• 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.

  PMID: 30198451 RESULT

• 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.

  PMID: 29485536 RESULT

• 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.

  PMID: 20336327 RESULT

• 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.

  PMID: 17562631 RESULT

• 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.

  PMID: 15509280 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Personal Satisfaction; Behavior

Study Officials

• Sophie Lantheaume, Dr

  Ramsay Santé - Hôpital Privé Drôme

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JF oudet

CONTACT

683346567; jf.oudet@ecten.eu

MH BARBA

CONTACT

664888704; mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: April 15, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 12, 2022

Record last verified: 2022-04

Locations

FR (1)