Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Chronic Disease

Head and Neck Neoplasms

Chronic Graft Versus Host Disease

Head and neck cancer patients monitored on registry

Patients who are diagnosed with head and neck cancer and monitored by the Otolaryngology - Head and Neck Surgery clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing paper-based systems for tracking patients. All head and neck cancer patients monitored by the clinic will be included.

Registry

Urmimala Sarkar, MD, MPH

To implement and evaluate a health information technology platform designed to support the management of patients with head and neck cancer in an urban, publicly-funded outpatient setting. This is an observational study; researchers will not assign specific interventions to study participants.

The investigators aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. The investigators will not assign specific interventions to the study participants, but rather observationally assess the effect of the HIT registry, designed to support routine medical care, on participants.

The investigators will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Otolaryngology - Head and Neck Surgery clinic that cares for patients with head and neck cancers. The study will assess patient outcomes and evaluate the time it takes for patients to progress through key treatment and post-treatment milestones before and after the HIT tool is implemented. The investigators will use models controlling for secular trend to estimate the effect of the tool on improving timely and successful completion of guideline-based care processes.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based systems previously used by the clinic to monitor its head and neck cancer patients. It will be implemented clinic-wide for all patients being treated for head and neck cancers. The investigators are not assigning a specific intervention to patients, but rather supporting the clinic and health system in the development of a population management platform that improves routine care processes. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

The HIT platform users are clinicians who are responsible for monitoring patients with head and neck cancer and agree to partner with the investigators to improve monitoring processes. The clinicians involved may be asked to voluntarily participate in surveys, interviews, focus groups, and program evaluations. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts, and software engineers. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, the platform users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. Patients will be added to the registry by a clinician if they are diagnosed with head and neck cancer. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians immediately. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.

Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers

Time from diagnosis to initiation of treatment

Proportion of patients that complete tumor board treatment recommendations

Time from diagnosis to presentation at tumor board

Time from diagnosis to first visit in oncology clinics

Proportion of patients who complete post-treatment radiation

Proportion of patients who are lost to follow-up

Agency for Healthcare Research and Quality (AHRQ)

University of California, San Francisco

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Anxiety Disorders

Prostatic Neoplasms

Adenocarcinoma

Pain

Prostatic Hyperplasia

Hyperplasia

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Bupivacaine

Nitrous Oxide

Anesthetics

Anesthetics, Inhalation

Anesthetics, General

Analgesics, Non-Narcotic

Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy.

After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position.

Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.

Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.

Self-Administered Nitrous Oxide

Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.

Oxygen

Heidi Rayala, MD, PhD

Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to determine whether administration of nitrous oxide at the time of prostate biopsy will improve a patient's experience of care.

Nitrous oxide is a well-tolerated inhaled anesthetic that has been used for decades in pediatric and adult populations and is largely viewed as effective and safe. In addition to analgesic effect, nitrous oxide also produces a dissociative euphoria and amnesia that could potentially improve patients' anxiety and experience of cancer care. When used as a single agent at concentrations ≤50%, the American Society of Anesthesiologists (ASA) classifies nitrous oxide as Minimal Sedation, producing a state in which a patient responds normally to verbal commands, maintains airway reflexes, and spontaneous ventilation. Over the past several decades nitrous oxide has become less common due to concerns of nitrous oxide environmental exposure to the care team. There are now Federal Drug Administration (FDA)-approved systems that allow patient self-administered nitrous oxide (SANO), and importantly, include a scavenger system to eliminate exhaled environmental nitrous oxide. These systems are rapidly being adopted throughout the United States in Urology practices, but to date, there have been no studies evaluating patient outcomes and possible risks with the adjunct use of SANO. This study is a prospective, randomized, controlled trial to assess patient perceived pain and anxiety related to prostate needle biopsy with or without SANO, and the frequency of complications associated with SANO. A secondary aim will be to demonstrate that the SANO at the time of prostate biopsy does not significantly increase burden on Urologist productivity, nor increase the difficulty of operator ease in performing the prostate needle biopsy.

Subjects will be randomized 1:1 to either SANO (treatment) or oxygen (placebo control) after completion of baseline assessment. The results of the randomization will not be disclosed to patients as part of the study (patient-blinded).

The operating urologist and study participant will be blinded to group assignment for the duration of the study.

Participants with a prostate may be eligible for the study.

Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

IPD is not intended to be shared to personnel outside of pre-defined research staff.

Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])

Anxiety experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Anxiety (VAS-A) (range: 0 \[no anxiety\] - 10 \[worst anxiety\])

Anxious traits exhibited after prostate biopsy as measured by the State Trait Anxiety Inventory (STAI) (range: 6-36; 36 being 'worst' anxiety).

Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy

Operating urologist filled out a survey to assess their perception of patient: Tolerating Insertion of rectal probe. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Operating urologist filled out a survey to assess their perception of patient: Patient maintenance of positioning. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Operating urologist filled out a survey to assess their perception of patient: Patient Tolerance of Procedure. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Principal Investigator

Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy.

After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position.

Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.

Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.

Oxygen: Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.

Total

Age, Continuous

Sex: Female, Male

White

Black/African American

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

History of Prostate Cancer Prior to Enrollment

Past Medical History of Depression

Past Medical History of Anxiety

Pre-procedural anxiety was assessed using the Visual Analog Scale for Anxiety (VAS-A, range:0-10, higher scores indicating worse anxiety).

Pre-Biopsy VAS-Anxiety

Pre-procedural pain was measured by the Visual Analog Scale for Pain (VAS-P, range:0-10, with greater scores indicating worse pain).

Pre-Biopsy VAS-Pain

Pre-procedural anxiety was assessed using the State Trait Anxiety Inventory (STAI, range:6-24, higher scores indicate worse anxiety)

Pre-Biopsy STAI

Dr. Heidi Rayala

Post-biopsy Pain (VAS-P)

Post-biopsy Anxiety (VAS-A)

Post-biopsy Anxiety Traits (STAI)

Time of Prostate Biopsy

Operator Assessment of "Tolerating Insertion of Rectal Probe"

Operator Assessment of "Patient Maintenance of Positioning"

Operator Assessment of "Patient Tolerance of Procedure"

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Skin Neoplasms

Breast Diseases

Skin Diseases

A Nurse Navigator will:

* Be present at the announcement consultation
* Give information on the outpatient circuit
* Offer assistance for patients over 75 years
* Complete onco-geriatric orientation questionnaires
* Take care of patients on the ambulatory circuit

Health care process with Nurse Navigator

Romain BOSC, MD

Romain Bosc, MD

laetitia Gregoire

The number of surgical procedures performed in ambulatory hospitalization for cancers of the skin or breast is increasing for medical and economic reasons. But the protocols of care and the clinical pathways are poorly adapted for elderly patients with physical or cognitive impairment.

The goal of this study is to test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital on the increase in the proportion of patients operated on an outpatient basis

Follow-up of Elderly Patients in Ambulatory Surgery

Ambulatory Process of Elderly Patient for Skin and Breast Cancer Surgery

Test the impact of an oncology ambulatory surgical care in patients aged 75 years or older, with breast or skin cancer and treated in Henri Mondor hospital

Test the impact of the new organization of care on the mortality

Test the impact of the new organization of care on the proportion of patients converted to conventional care

Test the impact of the new organization of care on the passage to emergencies

Test the impact of the new organization of care on the not programmed hospitalizations

Test the impact of the new organization of care on the autonomy (ADL/IADL)

Test the impact of the new organization of care on the institutionalization to Long-term care and skilled nursing facilities

Test the impact of the new organization of care on the passage to Long-term care and skilled nursing facilities

Test the impact of the new organization of care on the postoperative complications

Test the impact of the new organization of care on the costs of care

Test the impact of the new organization of care on patients' satisfaction

Test the impact of the new organization of care on quality of life (EQ50) (for the prospective part of the study)

Assistance Publique - Hôpitaux de Paris

Patients who elect to be monitored by an Active Surveillance protocol for prostate cancer

Patients who are diagnosed with prostate cancer and elect to be monitored by an Active Surveillance protocol by the Urology Clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing but suboptimal systems for tracking patients. All Active Surveillance patients monitored by the clinic will be included.

To implement and evaluate a health information technology platform designed to support the management of patients on active surveillance for prostate cancer in an urban, publicly-funded outpatient setting.

We aim to implement and evaluate a health information technology (HIT) registry at an urban, public delivery system. We will use systems engineering methodologies to design, develop, and implement the platform. The platform will be implemented in the Urology clinic that cares for patients with prostate cancer. We are conducting a prospective non-randomized pilot study that will follow men who choose active surveillance as a management strategy for prostate cancer. We aim to assess the impact of the HIT registry on patient monitoring and adherence.

The HIT platform seeks to improve the monitoring and alerting functionality of existing systems. Specifically, it replaces paper-based or ineffective computer-based systems previously used by the clinic to monitor its active surveillance patients. It will be implemented clinic-wide for all patients being monitored by an active surveillance protocol. The platform is approved for clinical use and research by the San Francisco Health Network and the University of California, San Francisco.

Research involves materials that are collected for nonresearch purposes, as well as low-risk research employing survey, interview, focus group, program evaluation, and human factors methodologies. We will solicit structured feedback from registry users designed to continuously evaluate and improve performance in a clinical area to reduce patient safety gaps. Patient medical records will be reviewed, but patients monitored on the registry will not be contacted by researchers.

Procedures are in place to monitor the registry. First, quality assurance is performed by the research team, information technology analysts in the San Francisco Health Network, as well as by the third-party software provider. This includes checking that data in the platform matches source data, such as data entered in the electronic health record. In addition, users are audited on a weekly basis. A data dictionary defining variables used in the platform exists and is updated as needed. The HIT platform users include clinicians who are responsible for monitoring patients on active surveillance for prostate cancer. Patients who are enrolled in the active surveillance program will be added to the registry by a clinician. The research team will support the clinicians in data analysis, although this will be performed with population-level, de-identified data. However, if unmediated adverse events are identified by the research team, the research team will alert the clinicians appropriately. The research team will also develop training materials and conduct training sessions to ensure that all clinicians responsible for monitoring patients on active surveillance are provided with up-to-date resources and accessible support. The HIT platform is designed to supplement, but not replace, the existing electronic health record. Data on the registry will be validated with source data and users will still engage with the source data and electronic health record as appropriate clinically and operationally.

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital

An Electronic Registry to Improve Adherence to Active Surveillance Monitoring Among Men With Prostate Cancer at a Safety-net Hospital: A Study Protocol

measured from date monitoring (e.g. prostate-specific antigen test or biopsy) is scheduled to date monitoring occurs.

Acceptability and feasibility of the intervention among clinicians will be measured using the Technology Acceptance Model (Venkatesh et al). Semi-structured interviews will be conducted to assess usefulness and ease of use.

The proportion of patients who are lost to follow-up, defined as three subsequent unsuccessful outreach attempts

Adherence to monitoring (e.g. prostate-specific antigen test every 3 months) will be assessed. Monitoring will be considered adherent if it occurs within 30 days of the recommendation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center
Follow-up of Elderly Patients in Ambulatory Surgery	NCT03604666	Breast Cancer Skin Cancer Surgery Ambulatory	Health care pro...	75 Years -	Assistance Publique - Hôpitaux de Paris
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Customized Registry Tool for Tracking Adherence to Clinical Guidelines for Head and Neck Cancers	NCT03546322	Head and Neck N...	Registry	18 Years -	University of California, San Francisco
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center
An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital	NCT03553732	Prostatic Neopl...	Registry	18 Years -	University of California, San Francisco

Spots Global Cancer Trial Database for ambulatory

Every month we try and update this database with for ambulatory cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ambulatory

Every month we try and update this database with for ambulatory cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ambulatory cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.