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

Sponsor
Ramsay Générale de Santé (Other)
Overall Status
Recruiting
CT.gov ID
NCT05365256
Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
98
1
2
36.5
2.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard distraction during chemotherapy treatment period
  • Behavioral: Virtual distraction during chemotherapy treatment period
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
98 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Impact of Virtual Reality on the Mental Health of Patients Undergoing Adjuvant Treatment for Colorectal Cancer VIRECAPS2
Actual Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Apr 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard time occupation of treatment period

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

Experimental: time occupation of treatment period by virtual reality

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

Outcome Measures

Primary Outcome Measures

  1. Level of psychological well-being [6 months]

    Total score from WEMWBS scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Privé Drôme Ardèche Guilherand-Granges Aura France 07500

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Sophie Lantheaume, Dr, Ramsay Santé - Hôpital Privé Drôme

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ramsay Générale de Santé
ClinicalTrials.gov Identifier:
NCT05365256
Other Study ID Numbers:
  • 2021-A02382-39
First Posted:
May 9, 2022
Last Update Posted:
May 12, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ramsay Générale de Santé
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2022