Bliss DTx Assessment During Course Care Including Port-A-Catheter Setting (EPATPAC)

Setting a Port-a Cath is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is placed in the upper part of the thorax, under the clavicle, and facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.

Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics, hypnotics or inhalation of MEOPA.

Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.

This study is based on the hypothesis that Bliss DTx use would :

• Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
• Reduce anxiety before setting a Port-a Cath
• Provide greater satisfaction with the treatment process from patient point of view
• Have organizational impacts, some of which could be economically valued

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Pain management with BLISS DTx; Other: Pain Management with site standard of care sedation protocol

Detailed Description

An implantable catheter port, also called Port-a Cath, is placed in the upper part of the thorax under the clavicle. Setting is performed in a surgical room, under ambulatory, by a specialist, under local anesthesia. This Port-a Cath is set up to facilitate the administration of certain anticancer drugs or to inject other treatments throughout the course of care.

Setting a Port-a Cath is painful and stressful. In addition to local anesthesia, patients are often offered a sedation: anxiolytics as premedication, hypnotics before or during the Port-a Cath setting, inhalation of MEOPA (equimolar mixture of oxygen and nitrogen protoxide, medicinal anxiolytic and analgesic gas , colorless and slightly odorous, mainly used in a hospital environment).

Virtual reality technology allows a person to be immersed in a virtual environment using a device consisting of headset audio and 3D display system. This is a non-invasive device that has an effect on the anxiety and pain level of patients. Butterfly Therapeutics has developed a Digital Therapeutics (DTx) called Bliss DTx which uses virtual reality augmented by sound and visual stimuli. A first clinical study with Bliss DTx which was released in 2021 showed that the pain level was not significantly different between "Bliss DTx" arm and "MEOPA" arm when performing osteomedullary biopsy.

Bliss DTx is also used in everyday practice by many doctors, surgeons, anesthetists and nurses, who do not observe significant pain difference between Bliss DTx and chemical sedations during the acts, but note interesting differences from an organizational point of view between the different methods.

A new evolution of Bliss DTx offers features that allow to increase winnings throughout the course including installation of a Port-a Cath.

This study is therefore based on the hypothesis that Bliss DTx use would :

• Be clinically equivalent to a standard protocol (use of hypnotics and/or anxiolytics and/or MEOPA and/or hypnosis conversational) to manage pain during Port-a Cath setting under local anesthesia
• Reduce anxiety before setting a Port-a Cath
• Provide greater satisfaction with the treatment process from patient point of view
• Have organizational impacts, some of which could be economically valued, contributing to optimization of the entire course care for patients with Port-a Cath setting

• Study Type: Interventional
• Enrollment (Estimated): 318
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katell Le Dû, MD; Phone Number: +33 2 28 25 56 87; Email: dr.ledu@groupeconfluent.fr

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU Angers
    • Contact: Jean PICQUET, MD; Phone Number: + 33 2 41 35 38 37; Email: jean.picquet@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient, male or female, aged ≥ 18 years
• Patient with a cancer diagnosis
• Patient with Port-A-Cath setting under ambulatory
• Patient affiliated to or beneficiary of a social security system
• French speaking patient having signed informed consent

Exclusion Criteria:

• Patient with previous Port-A-Cath setting
• Patient with pain perception disorder
• Patient with contraindication to the use of virtual reality (VR) and screens
• Pregnant woman
• Protected patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLISS Arm; Port-A-Cath setting under local anesthesia combined with Bliss DTx use	Device: Pain management with BLISS DTx; Bliss DTx is a Digital Therapeutics (DTx) which uses virtual reality augmented with sound and visual stimuli to reduce pain during Port-A-Cath setting
Other: GOLD STANDARD Arm; Port-A-Cath setting under local anesthesia combined with site standard of care sedation protocol	Other: Pain Management with site standard of care sedation protocol; Sedation (morphine and/or hypnotics and/or anxiolytics and/or conversational hypnosis) reduces pain during Port-A-Cath setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Maximum pain level during Port-A-Cath setting will be assessed using Visual Analog Scale : from 0 (no pain) to 10 (intolerable)	1 day
Patient anxiety	Patient anxiety before Port-A-Cath setting will be assessed with Hamilton score. Score 10 to 13: mild depressive symptoms. Score 14 to 17: mild to moderate depressive symptoms. Score greater than 18: moderate to severe depressive	1 day
Patient satisfaction	The overall experience score and patient satisfaction will be assessed using the e-Satis questionnaire in ambulatory surgery (MCO CA) at the end of the treatment course. This a specific french questionnaire without global final score. There are only questions with following rating : poor, weak, medium, good, excellent	1 day

Collaborators and Investigators

• Sponsor: Butterfly Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Estimated): May 12, 2025
• Study Completion (Estimated): May 12, 2025

Study Registration Dates

• First Submitted: July 2, 2024
• First Submitted That Met QC Criteria: July 2, 2024
• First Posted (Actual): July 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-A02483-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No