Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Analgesics

All Drugs and Chemicals

The usual care group will receive the typical hospice care and interact with PAINReportIt to provide data necessary for the analysis of study aims. They will use the tablet computer at baseline and at the study end and daily between. They also will have access to what looks like PAINUCope, but is really computer games so that they have similar attention with the computer as the experimental group. For ethical purposes, we will provide a PAINReportIt Summary to their hospice nurses to have access to their pain assessment information, something we did not do in previous studies focused on efficacy of the interventions.

We will use Nursing Consult LLC's PAINRelieveIt software that includes: (1) PAINReportIt that has screens to collect pain, medications, and misconception data; (2) the intervention for the nurse clinicians, PAINConsultN; and (3) the intervention for the patients and lay caregiver, PAINUCope. This innovative, new program is the first computerized, multi-dimensional, self-report measure of pain with clinician decision support for analgesic prescriptions and multimedia patient education tailored to the patient's misconceptions and pain. Prototype versions of PAINConsultN and PAINUCope were tested in recently completed studies among outpatients with cancer and patients with sickle cell disease in outpatient, emergency and hospital settings.

PAINReportIt is a software program first developed with an electronic MPQ (1970 version) and now includes questions about analgesics used by the patient and a shortened version of the pain Barriers Questionnaire (BQ). PAINReportIt is designed as an interactive, touch screen method for assessment of pain. It can be self-administered and requires little or no patient computer experience and minimal or no provider time for administration. Directions for self-administration allow the patient to read instructions on-screen and practice making all types of selection responses that are available in the program. Directions from the paper and pencil tools were modified to address the touch screen method of recording patient responses. The copyright is owned by Dr. Ronald Melzack for the MPQ and Dr. Sandra Ward for the BQ. Both of these individuals have authorized the modifications, presentation format, and computerized use of their tools.

PAINReportIt

PAINConsultN for hospice nurses. Our previous studies support the feasibility and clinical effect of PAINConsultN. This narrative and graphic tool provides decision support for the nurse's clinical decisions regarding management of the patient's pain. Based on the PAINReportIt output and published cancer pain guidelines, PAINConsultN generates an algorithm-based consultation report with a list of recommendations that could be useful to provide improved pain relief. If the patient's PAINReportIt output indicates the pain level is consistent with the patient's goals for pain management and represents no pain or a mild pain level, the consultation report acknowledges the therapy plan and reinforces its consistency with pain guidelines.

PAINConsultN

We tested the prototype of the PAINUCope component of the intervention in three completed studies. PAINUCope is a multimedia, computer generated tool that provides tailored patient information to overcome their misconceptions about pain and to help them engage in self-care activities that contribute to reducing their pain. PAINUCope focuses on two crucial aspects of pain management: 1) reporting cancer pain; and 2) safe and effective use of pain medicines. All the educational materials were written at a 6th grade reading level and presented as 21st Century best-practices, evidence-based facts or scripts for the person living with cancer or sickle cell disease (in one study). The facts or scripts are customized to the patient's need for this type of health information. The patient's responses on PAINReportIt govern the specific health information that is shared with the patient via PAINUCope.

PAINUCope

Diana J Wilkie, PhD

The study purpose is to compare usual hospice care and PAINRelieveIt groups for effects on: (1) patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250 cancer patient-caregiver dyads receiving hospice care; and (2) nurse outcomes (obtained appropriate analgesics for patient) in a sample of hospice nurses. The investigators hypothesize that at posttest, controlling for pretest data and compared to the usual care group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a larger proportion who report satisfaction with pain intensity and whose nurses obtained appropriate analgesics for the patients' pain.

Unrelieved cancer pain at the end of life is a major health problem and is inconsistent with patient-centered goals for their last days. Building on a successful approach researched in outpatient oncology settings, the investigators propose a study testing PAINRelieveIt, a system-level intervention of computerized tools with patient-reported pain outcomes (in English, Spanish, Chinese languages), decision support for clinicians (English) and multimedia education tailored to each cancer patient and lay caregiver.

Using a 1-week pre-test/post-test randomized design in patients receiving home level hospice care provided by two Chicago-area hospices, we will compare effects of usual hospice care with PAINReportIt Summary and usual hospice care with PAINRelieveIt on pain outcomes. The tablet-based PAINRelieveIt includes valid and reliable pain tools (PAINReportIt), a summary of the patient's pain data with decision support for hospice nurses to obtain recommendations for algorithm-based analgesic therapies (PAINConsultN), and multimedia education tailored to the patient's and lay caregiver's pain management misconceptions (PainUCope). Patient's/caregiver's answers are automatically stored in an electronic database, from which the system generates a PAINReportIt Summary (usual hospice care control group); PAINConsultN and PainUCope (experimental group). All patients will receive usual hospice care. All patients/caregivers will complete PAINReportIt at pretest and 1-week later (posttest); patients also complete parts of PAINReportIt daily. Via daily e-mail updates, the control-group hospice nurses will receive a PAINReportIt Summary and experimental-group hospice nurses will receive a PAINConsultN. Additionally, experimental group patients/caregivers will view multimedia educational materials via PAINUCope to help patients report pain and adhere to prescribed analgesics.

Specific aims are to compare usual hospice care and PAINRelieveIt groups for effects on:

1. Patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250 cancer patient-caregiver dyads receiving hospice care.
2. Nurse outcomes (obtained appropriate analgesics for patient) in a sample of hospice nurses.

The investigators hypothesize that at posttest, controlling for pretest data and compared to the usual care group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a larger proportion who report satisfaction with pain intensity and whose nurses obtained appropriate analgesics for the patients' pain.

Findings will guide future system-level research to implement PAINRelieveIt in a multi-site, longitudinal trial that will test the effect of disseminating this technology on clinical decisions for managing pain and patient/caregiver pain outcomes in a national sample of hospices. This approach offers improved pain control for dying patients and other populations.

Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice

Misconceptions are measured with a computer version of the Barriers Questionnaire (BQ) with response options from 0 to 5 indicating the amount of agreement with statements about barriers to pain assessment or management. Items relate to communicating with the physician about pain, side effects of analgesics, concerns about addiction, tolerance, disease progression, and being perceived as a good patient. Validity of the BQ is supported by its ability to discriminate cancer patients who report high BQ scores and also were under-medicated for their pain level and were hesitant to report their pain to their clinicians. To improve the acceptability of the tool to patients with cancer, we reduced the tool to 13 items with demonstrated validity and reliability. In prior cancer studies, patients found it to be a simple, easily understood tool that they completed in 5 minutes or less on 13 screens using a touch-screen pentablet computer.

Satisfaction with pain levels is measured by two single item questions that ask the patient if he or she is satisfied with the level of pain. A three-option response allows the patient to indicate yes, no, or not sure. We tested this item in our previous study and found that 49% of patients were satisfied with their pain level at baseline were also satisfied 4 weeks later, 21% became satisfied, 18% became less satisfied and 12% were never satisfied during the 4-week study. These data are consistent with the high percentage (98%) of patients who reported a desire for no pain but whose worst pain was greater than the level they desired. Focusing on satisfaction with level of pain allows us to have greater variability in this variable than has been typically noted by other investigators.

We will measure the appropriateness of analgesics prescribed by review of the hospice medication list that is required to be in the home. The proportion of participants with an appropriate analgesic prescription will be calculated using Cleeland's Pain Management Index (PMI). The PMI is an indicator of the appropriateness of pain prescriptions based on the patient's reported pain intensity level. Calculation of the PMI requires a medication score and a worst pain intensity score. The PMI score is calculated by subtracting the worst pain category score from the prescribed pain medication score. Negative PMI scores indicate inadequate analgesics (coded as appropriate, no) and 0 or positive PMI scores indicate appropriate analgesics (coded as appropriate, yes).

worst pain intensity in previous 24 hours measured on 0 to 10 scale where 0 means no pain and 10 means pain as bad as it can be.

Analgesic adherence is derived from data regarding analgesics documented as prescribed (available to the patient as indicated from the medication list in the home) and analgesics consumed (from PAINReportIt). We will calculate the prescribed and 24 hour analgesic consumption for around the clock (ATC) and as needed (PRN) analgesics, but not the emergency analgesic pack opioids. We will calculate an analgesic adherence rate (dose reported as consumed divided by dose documented as prescribed, multiplied by 100) for all World Health Organization (WHO) analgesics (adjuvants, NSAIDs and non-opioids, and ATC and PRN Step 2 and Step 3 opioids).

Patient-Centered Outcomes Research Institute

Horizon Hospice & Palliative Care

Rainbow Hospice

University of Illinois at Chicago

Adjunct Professor

Adjuvants, Anesthesia

Central Nervous System Depressants

Pharmaceutical Solutions

Psychotropic Drugs

Anti-Dyskinesia Agents

Antiemetics

Gastrointestinal Agents

Anticoagulants

Emetics

Other Dietary Supplements

Fentanyl

Oxycodone

Midazolam

Haloperidol

Haloperidol decanoate

Analgesics, Opioid

Citric Acid

Sodium Citrate

Scopolamine

Metoclopramide

Butylscopolammonium Bromide

Antipsychotic Agents

Heroin

Cyclizine

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

Narcotics

Citrate

Medication administered by family / carer for symptoms

Standard subcutaneous medication - diamophine and / or midazolam administered by nursing staff

From 28/11/17 following approval from sponsor, ethics committee and MHRA a 3rd observational arm was introduced:

Epistatus administered PRN by family / carer for symptoms

PecFent will be supplied by Archimedes Pharma as two strengths of nasal spray solution at 1000 or 4000 mcg/mL fentanyl (as citrate). One spray contains 100 mcg or 400 mcg fentanyl (as citrate). Each bottle contains 1.55 ml ensuring delivery of 8 sprays of 100 or 400 mcg fentanyl (as citrate). PecFent is a commercially available product and packaging will be in accordance with the manufacturing authorisations (EU/1/10/644/001, EU/1/10/644/002, EU/1/10/644/005, EU/1/10/644/003, EU/1/10/644/004, EU/1/10/644/006).

Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth.

PecFent and Epistatus

Subcutaneous as needed medication will include:

* Opioids for pain or dyspnoea

  * Diamorphine
  * Oxycodone
  * Fentanyl
* Benzodiazepine and / or anti-psychotic for agitation

  * Midazolam
  * Levomepromazine
  * Haloperidol Anti-emetic for nausea
* Cyclizine
* Metoclopramide
* Haloperidol
* Levomepromazine
* Anti-secretory drug for respiratory secretions
* Glycopyrronium
* Hyoscine butylbromide
* Hyoscine hydrobromide

Standard subcutaneous medication

Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per "Specials" licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth.

Epistatus Alone

Paul Perkins, MB BCh FRCP (UK)

When patients are dying they become unable to take oral medication and if they develop symptoms (e.g. pain or agitation) they need to be given a subcutaneous injection of medication. If they are at home this requires that a District Nurse is called and it can take a long time (sometimes hours) for the Nurse to arrive. This can be a very stressful time for the patient and family.

There are 2 drug preparations which could potentially be given by family members in the home:

Nasal fentanyl (PecFent) Buccal midazolam (Epistatus) If these preparations helped symptoms this would give much quicker symptom control for patients and might mean the District Nurse visit was not needed.

In advance of a community based randomised trial of these modes of administration, it is important to assess the feasibility of such an approach in terms of carer acceptability and patient tolerability as well as determine appropriate sample sizes and sampling methods. There are 2 work packages which would help assess feasibility of a community trial:

1. An open label randomised controlled trial comparing the use of PecFent with or without Epistatus versus standard subcutaneous breakthrough medication for the management of breakthrough pain (with or without agitation) in dying hospice patients who either remain in the hospice or go home.
2. A qualitative interview study to capture the thoughts of relatives of these patients about the use of these preparations.

This will be an open-label, randomized, controlled feasibility pilot study to evaluate whether using nasal fentanyl (PecFent: 100, 200, 400 or 800 mcg) alone or in combination with buccal midazolam (Epistatus: 2.5, 5 or 10 mg) has the possibility to give better breakthrough symptom control to dying patients when compared with standard subcutaneous medication (Figure 1 A and B).

Each subject and their carers/family members will receive verbal and written information followed by signing of the Informed Consent Forms (ICFs). The study is divided into two arms. In both arms patients will receive standard regular oral or subcutaneous medication for relieving non-breakthrough symptoms. In the standard care arm, patients will receive standard as needed medication (SANM) administered orally, sublingually or subcutaneously for breakthrough symptoms. The experimental arm will consist of two stages: in Stage 1 of the study, PecFent will be given to patients in order to treat breakthrough pain instead of subcutaneous opioids. PecFent will be titrated in order to establish an effective treatment dose to manage pain. SANM administered orally, sublingually or subcutaneously will be used to treat agitation and other symptoms.

After the effective treatment dose of PecFent has been established patients will enter stage 2. Patients will not move to stage 2 if the treatment dose of PecFent is not deemed effective. Stage 2 will test a range of doses of Epistatus in terms of efficacy in treating agitation alone instead of subcutaneous midazolam (or in combination with the effective treatment dose of PecFent for pain and agitation).

SANM will be used to treat other symptoms. Assessment of effectiveness of any as needed medication will be conducted at 30 minutes from administration. If PecFent, Epistatus or a combination of both is ineffective, administration of SANM will be considered. Further opioid cannot be given within one hour but benzodiazepine can be given within 30 minutes as is standard practice in this setting. Thus, patients in the experimental arm will receive symptom relief regardless the efficacy of test drugs.

Nasal Fentanyl and Buccal Midazolam for Dying Patients

Can Nasal Fentanyl and Buccal Midazolam Give Better Symptom Control for Dying Patients When Compared With Standard Subcutaneous Medication? Pilot Randomised Controlled Trial and Qualitative Interview Study.

Happy for researchers to contact us once data has been analysed and published

Data will be captured by patient and/or carer and/or staff with regard to time from need for breakthrough medication (recognition of symptom) to adequate symptom control ('comfortable').

Data will be captured by patient and/or carer and/or staff with regard to time from need for breakthrough medication (recognition of symptom) to administration of drug.

Data will be captured by patient and/or carer and/or staff with regard to need for additional oral or subcutaneous medication

Data will be captured by patient and/or carer and/or staff with regard to symptoms recurring.

The modified Palliative care Outcome Scale Symptom list (POS-S) (patient /carer/ staff versions) at approximately the same time daily (depending on when family / carers are likely to be present).

For this study the Palliative care Outcome Scale Symptom list (known as POS-S) has been modified by removing the question on 'Any other symptoms' and with the addition of the anxiety question from the Integrated Palliative care Outcome Scale (IPOS).

Visual analogue scales for pain and agitation completed by patient (where possible), relatives and staff at baseline (Time X), time 0 (dose), 5, 10, 15, 20, 25 and 30 minutes (post-dose calculated from time 0) for 1 breakthrough episode per day

Adverse event information will be collected by research staff.

Gloucestershire Hospitals NHS Foundation Trust

Consultant in Palliative Medicine

Behaviors and Mental Disorders

Death

Quality of Life

A group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care.

This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).

Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.

Standard of care

Shanthi Sivendran, MD, MSCR

Randy Oyer, MD

Nik Buescher

Joan Harrold, MD

Barbara Martin, PhD

Kristina Newport, MD

Michael Horst, PhD

Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study). The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).

Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A decision on funding the full study should be forthcoming in the early part of 2015. The primary aim of the study is to compare the proportion of advanced cancer patients who have a hospitalization or emergency department visit in the last 6 months of life before and after implementation of a new care model that provides more comprehensive symptom management and supportive care, including earlier referral to palliative care. The secondary comparative aim is to assess measures of quality of life and satisfaction in both groups. To accomplish the aims of the study by the end of the funding period, we propose to begin data collection in advance of a funding decision. Should the study not receive funding, the data collected will be used to inform decisions regarding other funding applications and/or implementation of program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent more than minimal risk for the patients enrolled.

This protocol is for the first phase of the study, which is the enrollment and collection of data on the control group, to serve as the baseline for comparison regarding hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve sufficient number of subjects and observed deaths in the control group, we are targeting the start of enrollment and data collection in this group during the third quarter of 2014. If the project is funded, the intervention and enrollment in the intervention group are targeted to start in the second quarter of 2016. Background and study aims are presented for the entire project to provide context, but the intent of this application is only for approval of the enrollment and data collection on the control subjects (which contributes to aims 2 and 3 of the larger project). A second protocol would be presented for review and approval at the start of the intervention if the project funding is granted.

In phase one of the project, subjects would be approached and consented at the point of a determination/diagnosis of advanced cancer and followed until the end of life or the start of the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.

This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).

Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm

All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission

Assessed with FACT-G (Functional Assessment of Cancer-General measure)

Assessed with FAMCARE-2 (patient and family satisfaction with care)

Assessed with BASC (Brief Assessment Scale for Caregivers) Caregiver Burden

Assessed with the ESAS-R (Edmonton Symptom Assessment System Revised) and ECOG (Eastern Cooperative Oncology Group) performance status

Lancaster General Hospital

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.

Subjects in this arm will continue to receive standard care from their healthcare providers during the initial study period (i.e. no intervention). After four weeks, subjects will then participate in Reimagine's online Four Conversations program.

The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.

Four Conversations

Sophia K Smith, PhD

The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program. The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.

Four Conversations RCT

Four Conversations Randomized Controlled Trial

Clickstream data associated with viewing videos and other web content (e.g., social community) on the Reimagine website will be collected and analyzed through a web analytics software package. Session attendance will be collected by the Reimagine staff (specially trained counselors called Pillar Guides) and sent to the study team for analysis following each of the online meetings.

The Program Satisfaction \& Evaluation questionnaire was developed by the study team to assess perceived helpfulness of the program in terms of outcomes and patient-provider communication. Points are totaled and summed.

The Preparation for Decision Making Scale is a reliable and validated self-reported measure of the patient/caregiver or provider's perception of how useful a decision support intervention is in preparing the respondent to communicate with others making a health decision. Items are summed and scored, then divided by 10; scores can be converted to a 0-100 scale. Higher scores indicate higher perceived level of preparation for decision making.

The Decision Self-efficacy Scale is a reliable and validated instrument that measures self-confidence or belief in one's abilities in decision making, including shared decision making (SDM). Items are summed, divided by 11, and multiplied by 25. Scores range from 0 to 100 (very confident).

The Decisional Conflict scale is a reliable and validated measure of the state of uncertainty about a course of action. Items are summed, divided by 16, and multiplied by 25. Scores range from 0 to 100 (high decisional conflict).

The content of the City of Hope End of Life Knowledge Assessment was revised to reflect the program curriculum. Correctly answered questions will be awarded one point, summed, and a total score generated.

The PROMIS Global Scale is a reliable and validated measure of general perceptions of health. Items are predictive of care utilization and mortality. The scale produces two health scores: physical and mental. Items are summed and converted to t-scores.

The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations. Points are totaled and summed.

Duke Cancer Institute

National Comprehensive Cancer Network

Pfizer

Pillars4Life, Inc.

Duke University

members of the Taiwan Academy of Hospice Palliative Medicine

members of the Taiwan Society of Cancer Palliative Medicine

Administering of artificial hydration to terminal cancer patients

Administering of artificial hydration

Shao-Yi Cheng, MD,MSc,DrPH

I Ann Hsiao, MD

Shao-Yi Cheng

Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a common practice especially when patients are incapable of oral intake; however, there is a lack of research on indications and practices for the provision of artificial hydration to terminal cancer patients in Taiwan. The investigators aim to conduct a nationwide survey of palliative care physicians on their indications (general or specific), and practices of providing artificial hydration to terminal cancer patients. With that understanding of reasoning and clinical practice, the investigators would further establish an indigenous, evidence-based consensus guideline to serve as a reference for physicians in Taiwan.

Methods: The study is comprised of two parts. The first part is to conduct a nationwide survey of palliative and oncology care specialists with a questionnaire designed from literature reviews and principles of clinical ethics. After validation of the questionnaire, the investigators will e-mail it to members of the Taiwan Academy of Hospice Palliative Medicine and the Taiwan Society of Cancer Palliative Medicine. The primary outcome measure of the study is the indication and clinical practice of artificial hydration, and the secondary outcome is factors associated with the administration or withdrawal of hydration.

The second part is to establish a national consensus on clinical guidelines for administering artificial hydration, where the investigators will conduct a modified Delphi method for 6 rounds. Literature reviews will be first performed and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median and disagreement scores according to the Inter-Percentile Range Adjusted for Symmetry. Items voted for by 70% or more panelists will be selected and formalized into a consensus guideline.

Expected results: The investigators hypothesize that the indication to administer artificial hydration to the terminal cancer patient is multi-factorial and culturally based.

Conclusion: The establishment of a consensus guideline will help clinicians to make an appropriate decision from ethical, medical, cultural, and emotional factors and facilitate cancer patients to achieve a good quality of dying.

Background: The issue of artificial hydration for terminal cancer patients is a classic ethical dilemma in palliative care. It is a very common practice especially when the terminal cancer patient is incapable of oral intake; however, there is a lack of research on indications and practices for the provision of artificial hydration to terminal cancer patients in Taiwan. The investigators aim to conduct a nationwide survey of palliative care physicians on their indications (general or specific), and practices of providing artificial hydration to terminal cancer patients. With that understanding of reasoning and clinical practice, the investigators would further establish an indigenous, evidence-based consensus guideline to serve as a reference for physicians in Taiwan.

Methods: The study is comprised of two parts. The first part is to conduct a nationwide survey of palliative and oncology care specialists exploring the indication and practices of administrating artificial hydration to terminal cancer patients. The questionnaire is mainly designed from literature reviews and principles of clinical ethics. After validation of the questionnaire, the investigators will e-mail it to members of the Taiwan Academy of Hospice Palliative Medicine and the Taiwan Society of Cancer Palliative Medicine. A 200 NTD equivalent voucher/gift will be provided to each respondent as an incentive. The investigators will send two follow-up e-mail reminders after two weeks apart. The primary outcome measure of the study is the indication and clinical practice of artificial hydration, and the secondary outcome is factors associated with the administration or withdrawal of hydration.

To reach an 80% response rate, 1270 out of 1589 effective members need to reply to the questionnaire. Basic demographic data will be summarized as total numbers and percentages for categorical variables. Differences in categorical variables will be compared using t-test and Chi-square tests. Cronbach's alpha values of scales are calculated to determine the internal consistency of the scales used. Logistic regressions will be applied to determine factors affecting the administration or withdrawal of artificial hydration.

The second part is to establish a national consensus on clinical guidelines for administering artificial hydration. Taking the questionnaire result as a first-hand reference, the investigators will conduct a modified Delphi method for 6 rounds to reach a final consensus. The investigators will perform literature reviews and 14 sessions of one-to-one interviews in Round 1 to develop a draft. Subsequent rounds (Round 2-6) comprise questionnaire surveys among all panelists, teleconferences and e-mail discussions among core members, and cancer patients/patients' family discussions. Statistical criteria include median score, and disagreement score according to the Inter-Percentile Range Adjusted for Symmetry. Items with a total of 70% or more panelists voting will be selected and formalized into a consensus guideline.

Expected results: The investigators hypothesize that the indication to administer artificial hydration to the terminal cancer patient is multi-factorial and culturally based.

Conclusion: The establishment of the consensus guideline will help clinicians to make the appropriate decision from ethical, medical, cultural, and emotional factors and facilitate the cancer patient to achieve a good quality of dying.

Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan

Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients and Establishing Clinical Consensus Guideline in Taiwan

Anonymous survey and collated data would not reflect individual personal participant data

Multi-factorial and culturally based questionnaire in a nationwide survey of palliative and oncology care specialist, to explore the 5- to 9-point scale of opinion on indication and practices of administrating artificial hydration to terminal cancer patients

Statistical analyses of quality indicators from 14 sessions of one-to-one interviews and questionnaire surveys among panelists, to be formalized into a consensus guideline when over 70% of panelists voting for a questionnaire item

National Taiwan University Hospital

Infections

Respiratory Tract (Lung and Bronchial) Diseases

COVID-19

nurses who have worked in a palliative care or hospice unit

The first phase included a qualitative study. We conducted a qualitative phenomenological method to better explicate and understand palliative care nurses' emotional labor experiences, as well as the dilemmas and solutions they encounter when physical, mental, and emotional labor intertwine at work. In the early stage, we compiled an interview outline by a written qualitative meta-analysis about the emotional labor, and added the contents in the interview outline according to the actual situation in the later interview process.

interview

Yuxi Zhang, master

Hospice care is a nurse-led multidisciplinary team care that provides physical, mental, and social care to end-of-life patients. According to the WHO, the role of hospice nurses is addressing suffering involves taking care of issues beyond physical symptoms, to support patients and their caregivers. Different from other disease care, hospice nurses face end-of-life patients and their families. As the primary nursing contact of a dying family, hospice nurses have a more intense and complex emotional experience. In China, with the improvement of human rights protection awareness, the nurse-patient relationship is particularly important, and the social requirements for nursing workers are also getting higher and higher. In addition, hospice nurses not only provide physical and psychological care to patients, but also provide comprehensive care to families of end-of-life patients. It is not just the mental work of learning expertise and dealing with emergency situations, and the physical labor of caring for large numbers of patients; but also requires emotional labor that has rarely been recognized before. When facing end-of-life patients and their families, it is particularly important to express appropriate emotions and pay emotional labor.

Emotional Labor, Physical Labor and Mental Labor of Hospice Care Nurses: A Mixed-method Study

Emotional Labour, Mental Labour, Self-efficacy and Potential Influencing Factors of Hospice Care Nurses During COVID-19: A Mixed-method Study

The ELS for nurses was developed by Hong and Kim (Hong \& Kim, 2018), which is a 16-item scale using a five-point Likert scale ranging from 1 (not at all) to 5 (very true), with a total score ranging from 16 to 80. Higher scores indicate higher levels of emotional labor.

Chinese version of DASS-21 has a total of 21 items and measures three negative emotional experiences of depression, anxiety and stress (Jiang et al., 2021).

Nanjing University of Traditional Chinese Medicine

Professor

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Glioma

Brain Neoplasms

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Pinealoma

Astrocytoma

Ependymoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Lymphosarcoma

Pineocytoma

Primary Central Nervous System Lymphoma

Neuroepithelioma

Katherine E Warren, M.D.

Background:

- An important new area of brain tumor research is the development of tumor and brain stem cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh tumor and brain tissue, which is best accomplished by harvesting whole brains from recently deceased patients. These cell lines will help researchers understand how these tumors develop and will also help identify new targets for treatment. Researchers are interested in conducting a pilot study of planned inpatient hospice care with timely brain tumor tissue harvest at the time of death.

Objectives:

* To provide high-quality end of life inpatient hospice care for patients with untreatable brain tumors.
* To procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.

Eligibility:

* Individuals at least 18 years of age who have an untreatable primary brain or central nervous system tumor, are able to give informed consent (either their own or through a designated power of attorney), and have agreed to a Do Not Resuscitate order and Consent for Autopsy as part of the end-of-life care plan.
* HIV-positive individuals or those suspected of having infectious cerebritis are not eligible because of the potential for contamination of brain tissue.

Design:

* Participants will be enrolled in inpatient hospice admission to the National Institutes of Health Clinical Center either from home or from an outside hospital once a study investigator estimates an expected survival of less than 2 weeks.
* Participants will receive palliative care at the Clinical Center. Care will be tailored to each participant depending on the information provided in the individual's end-of-life care plan.
* Supportive medications such as antiseizure medications and pain relievers will be administered as appropriate.
* At the time of death, researchers will follow standard procedures for notifying next of kin and will collect brain tissue and tumor samples from the deceased.
* Following tissue collection, the deceased will be released for autopsy and funeral procedures.

BACKGROUND:

- Patients treated by the Neuro-Oncology Branch (NOB) for their brain tumors unfortunately and commonly succumb to their disease. They and their loved ones often seek a way of adding meaning and utility to their death by agreeing to donate brain tumor tissue for laboratory research that may serve the medical community, and ultimately other patients, through better understanding of these rare diseases. Important new avenues of brain tumor research includes the molecular characterization of tumor tissue, and the development of tumor and neural stem cell lines. Successful growth of these cell lines requires acquisition of large volumes of fresh tumor and brain tissue that can best be accomplished by harvesting whole brains from recently deceased patients. In an effort to provide high quality end of life care, with the additional intent of facilitating efficient donation of brain tumor tissue at the time of death, we are conducting a pilot study of planned inpatient hospice care incorporating timely brain tumor tissue procurement at the time of expiration.

OBJECTIVES:

* Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.
* Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.

ELIGIBILITY:

- Adult patients with primary brain tumors.

DESIGN:

- This is a pilot study to assess feasibility of procuring viable brain and tumor tissue proximal to the time of death. Target accrual is 10 patients for brain harvest.

A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes

National Cancer Institute (NCI)

Anxiety Disorders

Depression

Depressive Disorder

Dyspnea

Participants will be given a list of VR applications to choose from. They will then be given instructions by a research assistant (approximately 10 minutes) on how to use the selected application they have chosen, as well as time for any questions they may have before starting their VR experience. They will then have an approximately 30-minute session of that VR experience. They may or may not be accompanied by a family member or significant other and will also have a research assistant available to aid them in any difficulties experienced during the VR experience.

The intervention is a Virtual Reality experience within a selected application using an Oculus Quest 2 ©, as previously in the relevant intervention arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice	NCT02026115	Cancer Pain	PAINReportIt PAINConsultN PAINUCope	18 Years -	University of Illinois at Chicago
Nasal Fentanyl and Buccal Midazolam for Dying Patients	NCT02009306	Terminal Cancer	PecFent and Epi... Standard subcut... Epistatus Alone	18 Years -	Gloucestershire Hospitals NHS Foundation Trust
Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm	NCT02261051	Cancer Advanced Cancer	Standard of car...	18 Years -	Lancaster General Hospital
Four Conversations RCT	NCT02944344	Breast Cancer	Four Conversati...	18 Years -	Duke University
Nasal Fentanyl and Buccal Midazolam for Dying Patients	NCT02009306	Terminal Cancer	PecFent and Epi... Standard subcut... Epistatus Alone	18 Years -	Gloucestershire Hospitals NHS Foundation Trust
Exploring Indications and Practices of Administering Artificial Hydration to Terminal Cancer Patients in Taiwan	NCT06329856	Terminal Cancer Hospice Palliative Medi...	Administering o...	-	National Taiwan University Hospital
Emotional Labor, Physical Labor and Mental Labor of Hospice Care Nurses: A Mixed-method Study	NCT05608512	Hospitalism	interview	18 Years - 65 Years	Nanjing University of Traditional Chinese Medicine
A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes	NCT01251913	Ependymomas Gliomas PNET Pineal Tumors PCNSL (Primary ...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes	NCT01251913	Ependymomas Gliomas PNET Pineal Tumors PCNSL (Primary ...		18 Years - 100 Years	National Institutes of Health Clinical Center (CC)
Virtual Reality for Improving Symptoms in Palliative Care	NCT05197894	Cancer and Non-...	Virtual Reality	18 Years -	Western University, Canada
Four Conversations RCT	NCT02944344	Breast Cancer	Four Conversati...	18 Years -	Duke University

Spots Global Cancer Trial Database for hospice

Every month we try and update this database with for hospice 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 hospice

Every month we try and update this database with for hospice 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 hospice 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.