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

NCT06495528 | Recruiting

• 1 other identifier: 2023-A02483-42
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

BLISS Arm

EXPERIMENTAL

Port-A-Cath setting under local anesthesia combined with Bliss DTx use

Device: Pain management with BLISS DTx

GOLD STANDARD Arm

OTHER

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

Interventions

Pain management with BLISS DTx DEVICE

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

BLISS Arm

Pain Management with site standard of care sedation protocol OTHER

Sedation (morphine and/or hypnotics and/or anxiolytics and/or conversational hypnosis) reduces pain during Port-A-Cath setting

GOLD STANDARD Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Butterfly Therapeutics: lead

Study Sites (1)

CHU Angers

Angers, 49933, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Pain Management

Intervention Hierarchy (Ancestors)

Therapeutics; Disease Management; Patient Care Management; Health Services Administration

Central Study Contacts

Katell Le Dû, MD

CONTACT

+33 2 28 25 56 87; dr.ledu@groupeconfluent.fr

Study Design

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

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: June 12, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)