Breath-Hold Technique for Pancreatic Stereotactic Body Radiation Therapy (SBRT) Patients

NCT04843306 | Terminated

• 2 other identifiers: J20119IRB00265565
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigator proposes the development of an extended reality (xR) training platform for patients undergoing radiation treatment for pancreatic cancer. The Investigator wants to investigate the ability of this technology to provide biophysical feedback and coaching during the planning and treatment sessions to help patients with the ABC technique to improve motion management outcomes and reduce treatment related anxiety.

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Effectiveness of motion management for SBRT for pancreatic cancer with real-time coaching for the ABC procedure using an augmented reality platform

  The mean range of intra-fraction variation (in millimeters) will be used in assessing the effectiveness of motion management. The result will be compared to historical controls in a "pick the winner" design.

  Up to 3 months from final SBRT session

Secondary Outcomes (2)

• Quality of patient confidence with the ABC procedure with real-time coaching using an augmented reality platform during SBRT for pancreatic cancer as assessed by patient reported outcome measures (PROMs)

  Up to 3 months from final SBRT session

• Anxiety of patient with the ABC procedure with real-time coaching using an augmented reality platform during SBRT for pancreatic cancer as assessed by patient reported outcome measures (PROMs)

  Up to 3 months from final SBRT session

Study Arms (2)

ABC technique plus biofeedback

EXPERIMENTAL

Patients will utilize biophysical feedback and coaching during the planning and treatment sessions for radiotherapy to help patients with the ABC technique.

Behavioral: Biofeedback; Behavioral: Active Breathing Control Technique

Standard of care ABC technique.

ACTIVE COMPARATOR

Patients will standard of care instructions for using the ABC technique during the planning and treatment sessions for radiotherapy.

Behavioral: Active Breathing Control Technique

Interventions

Biofeedback BEHAVIORAL

Relaxation coaching will be used in this study.

ABC technique plus biofeedback

Active Breathing Control Technique BEHAVIORAL

Active breathing control (ABC) requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment.

ABC technique plus biofeedback; Standard of care ABC technique.

Eligibility Criteria

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

You may qualify if:

• Men and women over 18 years of age
• Patients with a histologically confirmed diagnosis of pancreatic cancer with borderline resectable or locally advanced disease
• Receiving stereotactic body radiation therapy for pancreatic cancer with active breathing control (ABC)
• Able to read and write in English or able to understand/answer study questions and instructions with the aid of an interpreter

You may not qualify if:

• Patients who do not provide informed consent
• Patients who chose not to answer the study questions
• Patients who chose not to use the xR device and platform
• Patients with a seizure history

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Amol Narang

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This will be a prospective, randomized, and non-blinded trial to assess the benefit of xR technology for patient education, coaching, and comfort during radiation treatment of pancreatic cancer. Prior to any use of the xR platform for patients, the investigators will perform several dry runs with the Radiation Oncology Physics department to confirm the device and platform can be used safely.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: June 3, 2021
• Primary Completion: August 18, 2023
• Study Completion: August 18, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

US (1)