Pancreas CancerNCT04843306
Breath-Hold Technique for Pancreatic Stereotactic Body Radiation Therapy (SBRT) Patients
A study testing Biofeedback in people with Pancreas Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2021to 18 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: "Real-time Augmented Reality Coaching for the Breath-Hold Technique for Pancreatic SBRT Patients"
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.
Read the detailed description
Pancreatic cancer (PCa) is a devastating diagnosis with one of the lowest 5-year overall survival rates of all malignancies. It is estimated that at least 45,000 Americans will die of this disease in 2019, making it the third most common cause of oncologic death. Of the patients that present without evidence of distant spread at the time of diagnosis, only a minority of patients are able to proceed directly to surgical resection which remains the mainstay treatment modality. Historical outcomes show that 30-40% of patients present with borderline resectable (BRPC) or locally advanced (LAPC) disease due to tumor involvement of local vasculature which prevents the patients from proceeding directly to surgery. In this context, neoadjuvant therapy with radiation is often administered in an attempt to downstage tumors prior to surgery, reduce the risk of a margin positive failure, and reduce the risk of local recurrence after surgery. For patients who are truly technically or medically unresectable, radiation can be offered with the intent of providing durable local control. Indeed, a recent autopsy study showed that 30 % of patients who expire from PCa do so due to the locally destructive spread from this disease, highlighting the imperative need for an optimal local control strategy.
Delivering radiation to the pancreas is technically challenging and must be carefully delivered given the risk of injury to radiosensitive organs at risk (OAR) in close proximity such as the bowel and stomach. Compounding this difficulty is the variation in positioning of the tumor and OARs due to respiratory induced motion and variation in bowel gas patterns. To achieve daily accuracy in tumor localization, the investigators employ a comprehensive strategy including strict immobilization, endoscopically placed fiducials, and daily on-board cone beam CT (CBCT). Moreover, the investigators utilize active breathing control (ABC), which requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment. Radiation to the pancreas is delivered only when the patient is holding patient's breath. During ABC, patients breathe through a snorkel-like device that records the volume of air inhaled during each breath. In this apparatus is a valve that will cut off the flow of air once the inhalation volume passes a certain threshold to ensure the same amount of volume is taken in each time a breath hold is performed. Patients are asked to press on a button to start the recording aspect of the device and then to take a deep breath hold. Once patients reach the desired threshold for the inhaled volume, the valve prevents any further air from being inhaled in, and the patient is asked to hold patient's breath for a duration of 20 - 30 seconds. The treatment team is not present in the room with the patient because of radiation exposure so it requires the patient to follow a series of with the treatment team over an intercom system. Patients are asked to do this without any visual biophysical feedback of patient's waveforms, and to do this repeatedly for multiple times per treatment session. The series of instructions can be challenging for many patients, potentially leading to prolonged treatment times and additional breath holds especially in the early fractions before patients become more familiar with the system. Furthermore, with only one planning session to become acquainted with the ABC device and treatment instructions, patients have limited practical time to gain mastery before returning for patient's actual treatment sessions. This is of concern since patients who struggle with the ABC technique may have less consistent reproducibility of daily tumor positioning which may lead to poorer radiation treatment outcomes.
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
- Being tested
- Biofeedback, Active Breathing Control Technique
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
Relaxation coaching will be used in this study.
Active Breathing Control TechniqueBehavioural
Active breathing control (ABC) requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Active Breathing Control Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Patient confidence will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 8 questions on a 5-point Likert scale to assess the patient's confidence in performing the ABC procedure with AR mode 1 or 2, and total score ranges from 0 to 32 with higher score signifying greater confidence.
Measured: 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)
Patient anxiety will be assessed with PROMs and the mean score for all patients treated in AR mode 1 will be compared to the mean score for all patients treated in AR mode 2. This PROM consists of 20 questions on a 4-point Likert scale to assess patient anxiety with the ABC procedure and total score ranges from 20 to 80 with higher scores signifying greater anxiety with the procedure.
Measured: Up to 3 months from final SBRT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start3 Jun 2021
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Why it stopped: Technical difficulties that were not able to be resolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amol Narang, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843306
- Sponsor's protocol ID
- J20119
- Other IDs
- IRB00265565
- Status last verified
- Jun 2024
- First submitted
- 8 Apr 2021
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Real-time Augmented Reality Coaching for the Breath-Hold Technique for Pancreatic SBRT Patients"
- ClinicalTrials.gov ID
- NCT04843306
- Acronym / sponsor ID
- J20119
- Conditions
- Pancreas Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical difficulties that were not able to be resolved.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pancreatic cancer (PCa) is a devastating diagnosis with one of the lowest 5-year overall survival rates of all malignancies. It is estimated that at least 45,000 Americans will die of this disease in 2019, making it the third most common cause of oncologic death. Of the patients that present without evidence of distant spread at the time of diagnosis, only a minority of patients are able to proceed directly to surgical resection which remains the mainstay treatment modality. Historical outcomes show that 30-40% of patients present with borderline resectable (BRPC) or locally advanced (LAPC) disease due to tumor involvement of local vasculature which prevents the patients from proceeding directly to surgery. In this context, neoadjuvant therapy with radiation is often administered in an attempt to downstage tumors prior to surgery, reduce the risk of a margin positive failure, and reduce the risk of local recurrence after surgery. For patients who are truly technically or medically unresectable, radiation can be offered with the intent of providing durable local control. Indeed, a recent autopsy study showed that 30 % of patients who expire from PCa do so due to the locally destructive spread from this disease, highlighting the imperative need for an optimal local control strategy.
Delivering radiation to the pancreas is technically challenging and must be carefully delivered given the risk of injury to radiosensitive organs at risk (OAR) in close proximity such as the bowel and stomach. Compounding this difficulty is the variation in positioning of the tumor and OARs due to respiratory induced motion and variation in bowel gas patterns. To achieve daily accuracy in tumor localization, the investigators employ a comprehensive strategy including strict immobilization, endoscopically placed fiducials, and daily on-board cone beam CT (CBCT). Moreover, the investigators utilize active breathing control (ABC), which requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment. Radiation to the pancreas is delivered only when the patient is holding patient's breath. During ABC, patients breathe through a snorkel-like device that records the volume of air inhaled during each breath. In this apparatus is a valve that will cut off the flow of air once the inhalation volume passes a certain threshold to ensure the same amount of volume is taken in each time a breath hold is performed. Patients are asked to press on a button to start the recording aspect of the device and then to take a deep breath hold. Once patients reach the desired threshold for the inhaled volume, the valve prevents any further air from being inhaled in, and the patient is asked to hold patient's breath for a duration of 20 - 30 seconds. The treatment team is not present in the room with the patient because of radiation exposure so it requires the patient to follow a series of with the treatment team over an intercom system. Patients are asked to do this without any visual biophysical feedback of patient's waveforms, and to do this repeatedly for multiple times per treatment session. The series of instructions can be challenging for many patients, potentially leading to prolonged treatment times and additional breath holds especially in the early fractions before patients become more familiar with the system. Furthermore, with only one planning session to become acquainted with the ABC device and treatment instructions, patients have limited practical time to gain mastery before returning for patient's actual treatment sessions. This is of concern since patients who struggle with the ABC technique may have less consistent reproducibility of daily tumor positioning which may lead to poorer radiation treatment outcomes.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ABC technique plus biofeedback | Experimental | Behavioral: Biofeedback, Behavioral: Active Breathing Control TechniquePatients will utilize biophysical feedback and coaching during the planning and treatment sessions for radiotherapy to help patients with the ABC technique. |
| Standard of care ABC technique. | Active comparator | Behavioral: Active Breathing Control TechniquePatients will standard of care instructions for using the ABC technique during the planning and treatment sessions for radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackRelaxation coaching will be used in this study. | Behavioural | ABC technique plus biofeedback |
| Active Breathing Control TechniqueActive breathing control (ABC) requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment. | Behavioural | ABC technique plus biofeedback, Standard of care ABC technique. |
Primary outcome
Effectiveness of motion management for SBRT for pancreatic cancer with real-time coaching for the ABC procedure using an augmented reality platform
Time frame: Up to 3 months from final SBRT session
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.
2 secondary outcomes
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)
Time frame: 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)
Time frame: Up to 3 months from final SBRT session
Results and safety
The study was stopped early (reason given: Technical difficulties that were not able to be resolved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amol Narang principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback in people with Pancreas Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Technical difficulties that were not able to be resolved.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of motion management for SBRT for pancreatic cancer with real-time coaching for the ABC procedure using an augmented reality platform (time frame: Up to 3 months from final SBRT session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.