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

Primary Purpose

Cancer of Colon, Virtual Reality

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standard distraction during chemotherapy treatment period
Virtual distraction during chemotherapy treatment period
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer of Colon focused on measuring virtual reality, Colorectal cancer, Quality of life, Mental Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Privé Drôme ArdècheRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard time occupation of treatment period

time occupation of treatment period by virtual reality

Arm Description

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

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)

Outcomes

Primary Outcome Measures

Level of psychological well-being
Total score from WEMWBS scale

Secondary Outcome Measures

Full Information

First Posted
May 4, 2022
Last Updated
May 6, 2022
Sponsor
Ramsay Générale de Santé
Collaborators
GCS Ramsay Santé pour l'Enseignement et la Recherche
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1. Study Identification

Unique Protocol Identification Number
NCT05365256
Brief Title
Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer
Acronym
VIRECAPS2
Official Title
Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer VIRECAPS2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
GCS Ramsay Santé pour l'Enseignement et la Recherche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon, Virtual Reality
Keywords
virtual reality, Colorectal cancer, Quality of life, Mental Health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard time occupation of treatment period
Arm Type
Active Comparator
Arm Description
habitual distraction of patients during chemotherapy sessions authorized as part of routine care (doing nothing, discussion, reading, games, etc.).
Arm Title
time occupation of treatment period by virtual reality
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Standard distraction during chemotherapy treatment period
Intervention Description
habitual distraction of patients during chemotherapy sessions authorized as part of routine care
Intervention Type
Behavioral
Intervention Name(s)
Virtual distraction during chemotherapy treatment period
Intervention Description
A virtual reality headset will be worn for 15 minutes per hour of treatment
Primary Outcome Measure Information:
Title
Level of psychological well-being
Description
Total score from WEMWBS scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JF oudet
Phone
683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
MH BARBA
Phone
664888704
Email
mh.barba@ecten.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie Lantheaume, Dr
Organizational Affiliation
Ramsay Santé - Hôpital Privé Drôme
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Privé Drôme Ardèche
City
Guilherand-Granges
State/Province
Aura
ZIP/Postal Code
07500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Lantheaume, Dr
Email
s.lantheaume@ramsaygds.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
22688373
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.
Results Reference
result
PubMed Identifier
26238976
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.
Results Reference
result
PubMed Identifier
19485613
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.
Results Reference
result
PubMed Identifier
30198451
Citation
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.
Results Reference
result
PubMed Identifier
29485536
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.
Results Reference
result
PubMed Identifier
20336327
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.
Results Reference
result
PubMed Identifier
17562631
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.
Results Reference
result
PubMed Identifier
15509280
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.
Results Reference
result

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

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