Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Death

Breast Neoplasms

Lung Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

All participants will engage in playing the end-of-life conversation game called "Hello", which involves answering open-ended questions about medical decision making and end-of-life issues.

To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').

Other Name: Previously named "My Gift of Grace"

End-of-life conversation game called "Hello"

Lauren Van Scoy, MD

The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with breast, lung, and/or genito-urinary cancers treated at Penn State Cancer Institute and their loved ones perform advance care planning. The main questions it aims to answer are:

* What modifications and/or adaptations are necessary to Hello for use in cancer populations?
* How do different delivery models compare for recruitment in terms of feasibility and efficiency?

Participants will:

* Complete pre-game questionnaires
* Play the Hello game
* Complete post-game questionnaires
* Participate in a focus group

Previous studies conducted by the investigators have shown that the Hello game demonstrates successful ACP engagement in general populations, but has yet to be tailored to meet the unique needs of patients with advanced cancer and their caregivers. Outlining their care preferences by engaging in ACP is an important aspect of care according to patients with advanced cancer. However, only 55% of patients with advanced cancer patients have participated in ACP. These patients have substantial bio-psycho-social stressors that distinguish their ACP needs from others. Tailoring established interventions that foster high quality conversations about medical treatment preferences and end-of-life issues (such as the Hello game) is critically important for this population given its unique needs. As evidenced by qualitative interviews with \>200 participants, the Hello game creates a safe environment for sensitive conversations about end-of-life issues and inspired sharing of rich perspectives, with no reported adverse events, excessive burden, or negative emotional effects. That said, the intervention must be adapted for patients with cancer, particularly those with advanced cancer and their caregivers.

Additionally, while several effective ACP interventions exist (including Hello), how best to disseminate these interventions has not been rigorously or systematically studied. In other ongoing and previous studies, the investigators have demonstrated success in both engaging individuals living in underrepresented communities in ACP and successfully enrolling them in interventional research about ACP. The investigators credit these successes to their unique intervention delivery approach called the Community Based Delivery Model (CBDM). The CBDM overcomes key barriers to ACP (such as healthcare distrust, resistance, and hesitancy to discuss end-of-life issues) by leveraging established community connections to recruit participants to participate in ACP interventions as well as research. In the CBDM, trusted community "hosts" (who are leaders from local hospice organizations, senior centers, health agencies) invite participants to attend an ACP event. They introduce the research team to the attendees who may choose to participate in the ACP activity, the research, or both. Hosts are provided with marketing materials and utilize their community network channels to advertise the event. This model allows for research to be conducted more easily within hard to reach and underserved communities such as Black, Hispanic and rural communities- much like the most remote communities across the PSCI's 28-county catchment area.

Patients with cancer, however, are unique, and may require an alternative approach that involves partnering with their oncology care team to introduce the concept of ACP and encourage participation in ACP and research. Notably, there is evidence that patients are more likely to engage in ACP when recommended by their physician, so how best to approach ACP for cancer patients is unknown. A common approach to ACP intervention research is to use a Healthcare Based Delivery Model (HBDM). In contrast to the CBDM, the HBDM is positioned within the healthcare system (i.e., clinic-based recruitment) as the ACP intervention is recommended by the patient's clinician (rather than through community-based outreach groups). For this intervention delivery approach, research assistants support interactions between clinicians (providers or nurses) to find appropriate patients and garner interest in performing ACP. This model is commonly used to recruit patients for clinical trials, including ACP interventions. For patients with cancer, the HBDM may have some advantages over the CBDM, given the close bonds that form between a patient and clinical care team as they interact frequently during active treatments such as infusions and radiation that often span several hours and weeks. Leveraging these therapeutic relationships may support greater acceptance of opportunities to broach ACP than a community-based model, but this remains unknown.

Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning

Adapting an Advance Care Planning Intervention and Delivery Model for Use With Patients With Cancer and Their Caregivers

Group discussions held with patients with cancer and their caregivers to collect qualitative data on acceptability of the game, necessary modifications for use in patients with cancer and their caregivers, and other feedback and opinions on the game experience.

This 4-item short-version survey measures readiness to perform ACP.

This 17-item survey measures surrogate decision maker readiness to perform ACP.

This 8-item survey measures participants' satisfaction with the conversation. Each item is scored on a 1-7 scale with 1 being lowest conversation satisfaction. The items are averaged for the final score ranging 1-7 with 7 indicating the highest conversation satisfaction.

This 3-item survey measures participants' perceived acceptability of the intervention.

Milton S. Hershey Medical Center

Professor of Medicine, Humanities and Public Health Sciences

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Immune System Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Diabetes Mellitus, Type 1

Hypoglycemia

Hyperglycemia

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Autoimmune Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Insulin

Insulin, Globin Zinc

The FreeStyle Libre 2 Flash Glucose Monitoring System (FSL2) is a CGM device with real time alarms capability indicated for the management of diabetes in persons aged 4 and older. The Sensor holds eight (8) hours of data at a time. In order to have a daily diary of the Glucose level the patients or family or HCP must read the sensor (with reader or app) at least every height (8) hours. Every day at least three (3) scans of the sensor should be performed using the reader or the Smartphone App, generally at wake up in the morning, in the afternoon and at the time to go to sleep.

The alarm system will be activated, so that the Glucose level is over the cut off limit of 180 mmol/L or when it is lower than the cut-off limit of 80 mmol/L, the patient and/or the family members and/or the caregiver will check the Glucose level by scanning the reader/smartphone over the sensor.

This arm will perform the usual standard routine for blood glucose monitoring in patients with insulin therapy, that is represented by at least three finger pricks/die according to the usual standards routine of each center.

Different frequency of finger pricks glucose measurements could be performed on the basis of health care professional patient assessment of each patient's needs.

FSL2 is an integrated continuous glucose monitoring (CGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. It is composed by a sensor and a reader. The Sensor, to apply on the back of the arm, continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require finger stick calibration and can be worn for up to 14 days.

The reader is a small handheld device that monitors glucose values in real-time to provide alerts and alarms which, when enabled, warn the user of Low Glucose, High Glucose or Signal Loss and prompt the user to scan the Sensor.

The FSL 2 System is CE mark, it is commercially available and in the current study it is being used in accordance with approved labeling. No modifications of FSL2 System have been performed for the utilization in the current study.

Continuous Glucose Monitoring

The control group is represented by the usual standard way for blood glucose (BG) monitoring. The control group will use a lancing device for finger samples for collection of blood drop to be put in the test strips to be read in the Glucose meter. Lancing devices, lancets and test strips used in the comparison groups are CE marked and are used according to the user's instructions.

Monitoring and/or self-monitoring of blood glucose using glucose meters and test strips provides quantitative measurements of fingerstick blood glucose at a single point in time for patients and their healthcare providers to monitor the effectiveness of glycemic control and make more immediate treatment with the right dosage of insulin. The usual standard routine for blood glucose monitoring in patients with DM and with insulin therapy is represented by at least three finger pricks/die according to the usual standards routine of each center.

Standard Care

Cancer patients with known or newly diagnosed (i.e. iatrogenic) Diabetes Mellitus (DM) in Palliative/Supportive Care will be enrolled. Patients will be randomly assigned to one of two groups. Patients included in the first group will monitor glucose levels through Continuous Glucose Monitoring (CGM), using the FreeStyle Libre 2 (FSL2). The second group is represented by the usual standard way for blood glucose (BG) monitoring (lancing device for finger samples). An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group patients of the second group will be switched.

Diabete Mellitus (DM) represents an emerging factor with an impact on the severity and the management of symptoms (pain, dyspnoea, fatigue, nausea, vomiting, dehydration) in PC/SC patients leading to a reduced QoL of patients and family members. It has been noted that infrequent Blood Glucose (BG) monitoring might result in a not clear definition about whether symptoms are associated with the dying process or caused by diabetes, leading to inadequate symptoms management.

It is estimated that more than 30% of PC/SC patients can be affected by DM type I or type II. The incidence of diabetes seems to be six times greater in cancer patients than in the general population.

Despite this high incidence, implementation of standard Guidelines on monitoring BG levels in the PC/SC setting is lacking and the existing Guidelines are mainly based on expert experience rather than real data obtained from well design studies as evidenced by a recent review. Currently, the available tool used to evaluate BG in PC/SC patients is mainly represented by the punctual finger-samples procedure, which is usually performed only when there is a suspect of hyperglycemia/hypoglycemia or routinely in PC patients with known DM before meals administration. Punctual finger-samples procedure has many limitations: it is uncomfortable and painful for patients, it requires training to patients and family members by Health Care Providers (HCPs) and requires time to HPCs for preparing/conducting the procedures. As a consequence, BG monitoring in PC/SC patients (especially in home care settings) with known DM and newly diagnosed DM is very poorly and infrequently performed and represents a real unmet medical need.

Recently, a very innovative device, Freestyle Libre 2 (FSL2) (Abbott), has obtained a CE mark for Continuous Glucose Monitoring (CGM) in diabetic patients. The system includes a self-applied sensor with a size of two-stacked quarters, that is easy to apply on the back of the upper arm; it employs a pre-calibrated sensor that measures the tissue glucose concentration repeatedly for two weeks and has a duration of accuracy measurements of 14 consecutive days; interstitial Glucose levels are easily check with a painless one-second scan by a smartphone App or a Reader with results represented by latest glucose concentration and trend direction. The scan with the App or the Reader should be applied at least every 8 hours in order to have the recording of the glucose level. FSL2 has real-time glucose alarms that notify if glucose level is going too low or too high (Free Style Libre 2 User's Manual).

The rationale of the proposed study is based on the CGM system using FSL2, that is highly matching the need of Glucose level monitoring in PC/SC patients with known or newly diagnosed (i.e. iatrogenic) DM. FSL2 has no/very little discomfort for patients and it is not painful, it is easy to apply, it is not time-spending for family members and HCPs and it requires very brief training for patients and family members. The alarm system of FSL2 can aware patients, family members and HCPs at any moment when the glucose level is over a predefined cut off value, allowing to implement the appropriate interventions (i.e. insulin administration or insulin dose adjustment) in order to prevent and manage Symptomatic hyperglycemia crisis. The recent International Consensus on Recommendations on CGM data interpretation are showing that in particularly frail population, Glucose level are maintained for 50% of the time in a range between 70 mg/dL and 180 mg/dL and for 50% of the time in a range between 180 mg/dl and 250 mg/dl. According to that Recommendations, the alarm could be activated when glucose is over a cut off level of 180 mg/dL. The alarm activation allows patients themselves, family members, HCPs to provide patients with the most appropriate intervention (i.e. administration or adjustment of insulin dosage) in order to prevent glucose level reaching the peak of severe hyperglycemia (\>250 mg/dl).

Similarly, FSL2 allows to monitor Glucose level decrease and to prevent severe hypoglycemic crisis (BG \<50 mg/dL).

On this basis, we would like to evaluate CGM by using FSL2 as a tool for appropriately managing Glucose levels in PC/SC advanced oncological patients with known or newly diagnosed DM in order to prevent severe hypoglycemic/hyperglycemic crisis, in comparison to the current usual procedures (finger samples procedures).

CGM by using FSL2 could have a very positive impact in improving glucose level management in the PC/SC setting, especially in the home care setting, contributing to an improvement of the QoL of patients/family members and the HCPs attitude to the importance of glucose level monitoring. The results of this study could lead to a new standard of care in the management of patients with advanced cancer with a known/newly diagnosed DM in PC/SC settings.

The study is a multicenter, multinational, randomized, open label, parallel groups study, conducted in order to show superiority of CGM by using FSL2 in comparison to usual care procedures (finger samples) in reducing severe hyperglycemic peaks in PC/SC advanced oncological patients with known/newly diagnosed DM.

An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group in respect to the control group, patients of the control group will be switched to CGM by using FSL2 and will be followed until the completion of the study.

GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.

GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients With Known/Newly Diagnosed Type I/Type II Diabetes Mellitus (DM) in Palliative Care/ Supportive Care (PC/SC) Setting.

First severe hyperglycemic peak (\>250 mg/dL) observed during evaluation

Abbott Diabetes Care

Antea Foundation

Nervous System Diseases

Neurodegenerative Diseases

Herve PICARD, MD MSc

In Paris, France, home hospice care for terminally ill patients is organized by four "palliative care networks". These networks are responsible for information sharing and coordination of all health care professionals working with the patient. Two different systems are in place to ensure continuity of care outside working hours, in such a setting. In the first system, palliative care specialists from the network are reachable over the phone 24/7 by the patient or its caregivers, whenever needed. In the second system, medical information about the patient, regularly updated by the network's medical team, is available to professionals via a secure website, so that in case the patient requires an urgent medical home visit outside working hours, the visiting physician has access to accurate information.

The study's goal is to compare patient's and caregiver's satisfaction between these two systems of continuity of care.

For that purpose, patients will be taken care of as usual by every palliative care network. In every instance where the patient or caregivers have reached out for medical help through the network's continuity of care system, the patient or caregiver will be called 5 days later by the investigation team to go through a satisfaction questionnaire (Likert scales)

Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks

Patient's (or caregiver's) satisfaction about the response given by the network's continuity of care system, after the patient or caregiver activated this system at night time or during week-ends or bank holliday, as measured on a 4-level Likert scale (verbal questionnaire by phone call)

Fondation Ophtalmologique Adolphe de Rothschild

Musculoskeletal Diseases

Digestive System Diseases

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Rare Diseases

Chronic Disease

Fibrosis

Rheumatic Diseases

Collagen Diseases

Cystic Fibrosis

Hematologic Diseases

Pancreatic Diseases

Gastrointestinal Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Disease Attributes

Connective Tissue Diseases

Chronic Graft Versus Host Disease

The Medical Honors Program students will fill out the Patient Provider Orientation Scale (PPOS). MHP students will then interview a patient with a chronic or life limiting illness.

The patients will fill out the PPOS scale. The patient will then have an Interview performed by MHP student

Investigators are interested in the impact that our activity has on the students' patient-centeredness. Investigators will use the Patient-Practitioner Orientation Scale (PPOS), which will be completed by both the student and the patient prior to the encounter. Following the interview, the co-investigators will lead a discussion with the patient and student. Investigators will discuss differences in patient and student PPOS scores, and how each party felt the interview went. Investigators will examine if the patients feel the interview differed from typical interactions with health care providers, and how this made the patient feel. The students will describe what was learned from the patients story as well as try to explore reasons why providers may not always learn the patient's illness story.

Patient Provider Orientation Scale

The MHP students took a course called Medical Humanities in the fall of 2016. MHP students learned patient interviewing skills and the importance of gathering the patients "illness story". The students will conduct an interview with a patient with chronic illness, which will be focused on gather information about how the patients illness affects daily life as well as interactions with the health care system.

Interview performed by MHP student

Robert Lawrence, MD

A qualitative study assessing the impact of early narrative medicine practice on Medical Honors Program (MHP) students' attitudes regarding patient-centered interactions, through interviewing patients with chronic or life-limiting illnesses to obtain their illness stories.

MHP students will develop a patient narrative for the patients interviewed. These narratives will be edited by the patient, and, with the permission of the patients, may be published as a collection of stories.

Teach MHP Students about obtaining the illness story and narrative medicine. This will be done during the curriculum of the Medical Humanities class in the fall of 2016.

Recruit patients on units and floors in Shands University of Florida (UF) Health that may potentially have patients that will be good candidates for enrollment in the patient narratives. These may include pediatric hematology and oncology patients, adult hematology and oncology patients, patients with diabetes, organ transplant patients, cystic fibrosis patients, and rheumatologic disorder patients. Investigators will communicate with child life/social workers, as well as faculty medical providers on these inpatient services to help identify appropriate patients for referral and recruitment. These faculty members will obtain authorization from the patient for the investigators to approach the patient regarding recruitment.

Once a patient has been identified, a co-investigator will introduce the project to the patient, review examples of the types of questions to be asked by the MHP student, provide opportunity for questions, obtain informed consent, and provide them with the patient-practitioner orientation scale (PPOS) for completion.

A MHP student will meet with the co-investigator, fill out the PPOS, and then interview the patient. The co-investigator will be present for the interview, but the investigator would like the MHP student to conduct the interview. The interview will be voice recorded with encryption for later transcription.

Following the interview, a co-investigator will lead a discussion to determine patient and student observations/opinions about such conversations. The co-investigator will address differences in PPOS responses from patient vs student, without specifically revealing the personal answers of each, and allow for discussion of how scales can be aligned to better the patient-physician relationship. This discussion will be voice recorded for transcription and qualitative analysis by the investigators

Following the interview, the MHP students will transcribe the patient narrative. During the interview, the student and patient will agree on whether the narrative is written from the first or third person point of view.

The initial informed consent will have a specific series of check boxes to address whether the patient approves of dissemination of their story. This initial consent will specifically state that this narrative will not be published prior to their approval of the final product. The patient will also have the opportunity to declare which patient identifiers, if any, will be changed for the publication. The narrative will be presented to the patient, who will then have the opportunity to make changes and edits. If extensive edits are necessary, a subsequent narrative will be presented to the patient for final approval prior to publication. The investigators will make every effort to get the patient approval in person, however because of the possibility of the patient being discharged before the narrative has been composed, investigators will identify an acceptable method of communication with the patient outside of the hospital (email, phone call) for this purpose. In the case of the patient being discharged and needing to obtain approval, verbal approval over the phone will be obtained by a co-investigator and a witness, and will keep this documentation in a binder locked in the PI's office.

Following the completion of the interviews, the MHP students will meet for a focus group to discuss as a group their observations from their patient encounters. This focus group will be audio recorded and transcribed by the co-investigators for qualitative analysis

After all patient narratives have been completed, narratives may be published in an online or book format, following the consent that the patient provided.

Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students

Patients to People: Examining the Effects of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes in Medical Students. A Qualitative Study

The PPOS is an 18 item questionnaire developed to evaluate patient centered care. The items are rated on a 6 point Likert-type scale. It has two separate parts, sharing and caring, that can be either summed or divided for scoring purposes. Higher scores indicate more patient centeredness.

Total from the questions related to "sharing" on the PPOS. The sharing portion relates to how open the provider is in sharing power in the patient-physician relationship, or in the case of the patient filling out the form, how much the patient wishes to share the power in the patient-physician relationship.

Total from the questions related to "caring" on the PPOS. The caring portion relates to how oriented the provider is in caring for the patient as a person and not just a disease.

qualitative measurement of topics and themes discussed in immediate post-interview discussion between the co-investigator, MHP student, and patient

qualitative measurement of topics and themes discussed in the focus group held following all MHP students completing their individual interviews

University of Florida

During the first visit music will be played live, during the second visit a recording will play.

During the first visit a recording will play, during the second visit music will be played live.

music therapy

a recording of the same music played by the music therapist

recording

David Blum, Prof.Dr.med.

The present study seeks to assess differences in feasibility and acceptability of music therapy played live and listening to a recording thereof at the palliative care ward of the University Hospital Zurich. As a secondary objective the investigators aim to extend the limited findings on the putative effect of music therapy in palliative care populations derived from objective measures of human autonomic response combined with subjective psychological outcomes to support evidence-based medicine. The investigators will implement a commercially available tracker, the wristband 287-2 by Corsano, to investigate multiple simultaneous biomarkers of autonomic response to music therapy and a recording thereof, such as heart rate, heart rate variability, electrodermal activity and distal body temperature.

To investigate subjective quality of life and psychological outcomes, the investigators will administer highly validated and widely used questionnaires, namely the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 15 Palliative Care, the Edmonton Symptom Assessment System and the Hospital Anxiety and Depression Scale.

The power of music to raise the spirits and to heal the soul should not be underestimated. There is growing recognition of the significance of music as a complementary treatment in palliative care, which is reflected in the growing body of scientific literature on the subject and in the popularly of music therapy among palliative care patients themselves.

Palliative care describes the holistic approach in the treatment of patients with advanced or incurable diseases, such as terminal cancer. In addition to conventional medical and nursing care, critical psychological, social and spiritual support is provided in palliative care. To this end, an interdisciplinary team of doctors, nursing staff, physiotherapists, occupational therapists, social workers, psycho-oncologists, chaplains and music therapists is involved.

Music therapy is defined as "the systematic use of music within a therapeutic relationship which aims at restoring, maintaining and furthering emotional, physical and mental health". The aim of music therapy in palliative care, in contrast, is to relieve symptoms of distress and improve quality of life among patients in the advanced stages of oncological disease. In Germany, national oncological guidelines currently recommend music therapy as a treatment option to alleviate anxiety and existential fear.

Music therapy encompasses both active and receptive techniques. Active techniques involve the patient in the production of music, such that they sing or play a musical instrument, possibly making planned gifts of songs to loved ones or for memorial services, whereas receptive techniques guide the patient in listening to music, both prerecorded as well as performed for them live. In cancer patients, the focus is placed primarily on music-assisted relaxation, generation of imagery, songs and improvisation. This heterogeneity of techniques studied in the literature on music therapy precludes an understanding of precisely what aspects of music therapy are most beneficial. Despite a diversity of approach, findings are promising, which in itself may be an indication as to whether the whole of music therapy is perhaps greater than the sum of its parts.

To practice music therapy according to the standards of evidence-based medicine, it is necessary to specify the intervention performed as well as the musical instrument(s) used. Moderators such as individual patient preferences and experience with music also may play an appreciable role; however, these are rarely systematically investigated.

Music therapy is conventionally administered by a trained music therapist and individual therapy sessions typically last 20 minutes. Training backgrounds of therapists vary, whereby in the United States a bachelor's degree in music therapy is the minimum requirement and board certification must follow in order for professional practice.

Few studies have investigated the efficacy of music therapy in palliative care patients. An emerging body of scientific literature in this clinical population suggests that music therapy may alleviate physical pain as well as psychological, social and emotional suffering. Spiritual needs may particularly benefit from music therapy.

Furthermore, a meta-analysis could show significant positive effects of music therapy on psychological wellbeing, physical symptoms and overall quality of life. Music therapy may favour various routine overarching themes in palliative care as well, such as pain management, relaxation, joy, hope, intensified spirituality and improved quality of life and may reduce anxiety and depression. Music therapy may outperform verbal exercises in inducing relaxation and reducing fatigue but not pain.

Despite the generally promising findings suggesting a benefit to psychological well-being assessed by subjective methods (e.g., visual analog scales, questionnaires, etc.) there is scant evidence derived from experiments utilizing objective outcome measures (e.g., autonomic response, etc.) with rigorous study design to support the efficacy of music therapy.

Findings derived from autonomic data suggest a benefit of music therapy characterized by increased parasympathetic tone accompanying improved subjective ratings of relaxation. Boosted high-frequency heart rate (HR) oscillations coincided with subjective relaxation score from visual analog scale after music therapy. In addition, blood volume pulse amplitude (BVP-A) was increased from baseline to post-therapy, indicating heightened vascular dilation due to greater parasympathetic activation, although just below the threshold of statistical significance (p = 0.07). In another analysis in the same sample, during music therapy higher levels of parasympathetically-mediated HR variability (HRV) were observed. Resting HR and blood pressure (BP) were reduced, whereas relaxation, comfort and happiness were increased. Increases in distal body temperature was observed in a sample of individuals undergoing chemotherapy. Anxiety related to chemotherapy was reduced by music therapy in this sample.

The present study seeks to assess differences in feasibility and acceptability of music therapy played live and listening to a recording thereof at the palliative care ward of the University Hospital Zurich. As a secondary objective the investigators aim to extend the limited findings on the putative effect of music therapy in palliative care populations derived from objective measures of human autonomic response combined with subjective psychological outcomes to support evidence-based medicine. The investigators will implement a commercially available tracker, the wristband 287-2 by Corsano, to investigate multiple simultaneous biomarkers of autonomic response to music therapy and a recording thereof, such as heart rate, heart rate variability, electrodermal activity and distal body temperature.

To investigate subjective quality of life and psychological outcomes, the investigators will administer highly validated and widely used questionnaires, namely the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 15 Palliative Care, the Edmonton Symptom Assessment System and the Hospital Anxiety and Depression Scale.

The proposed risk category of this study is A. Justification for this risk categorization is reflected in the safe and relatively low burden of the study design, which requires the participants to undergo music therapy, complete questionnaires and wear a small wristwatch-like apparatus for a few minutes. Moreover, compared to conventional clinical measurement of human autonomic response, which typically involves skin disinfection and abrading followed by application of adhesive electrodes, the 287-2 wristband by Corsano is comparatively far less invasive and therefore represents diminished burden for the patient during their participation in the study. Music therapy and questionnaires (EORTC QLQ-C15-PAL, ESAS and HADS) are routine tasks for palliative care patients and represent no significant additional burden. In addition, the EORTC QLQ-C15-PAL questionnaire is the validated short-form version of the EORTC QLQ-C30-PAL, whose design objective is reduced patient burden. Furthermore, music therapy and these questionnaires are the standard of care in palliative care. The investigators submit that risk category A is appropriate given these methodological and ethical considerations.

monocentric study utilizing a prospective repeated measures design

Differences in Acceptability of Music Therapy Sessions Played Live Compared to a Recording Thereof

assesses intervention acceptability, values 8 - 40, higher = better outcome

Assesses subjective symptom severity, values 0 - 120, higher = worse outcome

Assesses subjective quality of life, values 15 - 63, higher = worse outcome

Assesses subjective anxiety and depression, values 0 - 42, higher = worse outcome

Assesses subjective experience of the intervention

Heart rate (bpm) is a basic marker of autonomic response and can reflect mortality and disease

Heart rate variability reflects neuro cardiac regulatory capacity and is a strong prognostic marker of mortality and disease

Electrodermal activity is a reliable biomarker of arousal

Thermoregulation is tightly controlled and reacts to vigilance state

University of Zurich

Providing Videotape-based material \& tailored workbook to make informed choice of disclosing terminal illness to patients

Attention control arm:

Providing videotape-based material \& non-tailored workbook about pain control

an experimental intervention group that receives a decision aid consisting of targeted educational video and manual providing a protocol for disclosing terminal illness and aimed at improving communication between patients and their family

Providing tailored message on disclosing terminal illness

an attention control group that receives non-tailored video and manual on pain control

Providing non-tailored message on pain control

Young Ho Yun, MD, PhD

This study is a randomized controlled trial that will compare two arms: an experimental intervention group that receives a decision aid consisting of an educational video and targeted manual providing a protocol for the family members' disclosing terminal illness to the patients and aimed at improving communication, satisfaction with decision making process, and quality of life between patients and their family versus an attention control group that receives a video and non-tailored manual on pain control.

Inclusion and exclusion criteria:

This study is aimed at decreasing the decisional conflict among family members who are ready or not to disclose patients' terminal illness. The decision aid will lead to effective communication between patients and family and the effective decision making process will lead to the final outcome to improve the quality of life in patients and their family. This trial is limited to situations where the family and their patients are cognitively capable of participating in decision-making process.

Measures:

Baseline Measures. At baseline, before randomization, self-reported questionnaire is used to collect data. To correct possible confounders in this study, family' background variables are assessed on entry to the study, including sociodemographic and decisional conflicts, decisional-role preference, stage of readiness, level of anxiety and depression, and QOL.

Family decisional conflict is assessed using four subscales of the Decisional Conflict Scale which assessed how well informed participants feel about their choices and the associated benefits and risks; the clarity of their values; the support they have in the decision-making process; and their level of uncertainty. It consists of 16 items followed by a Likert response of 1, strongly agree, to 5, strongly disagree. A mean score is obtained for each participant. The Decisional Conflict Scale (DCS) is translated into Korean by two bilingual individuals, using a forward-backward translation procedure, and completed pilot test.

Family preference for role in decision making is assessed using a scale modeled on an instrument developed by Degner et al. We make family/patient dimension from modifying Degner and Sloan's second Control Preference Scale set, family/physician dimension. The options of modified set of five cards (family/patient dimension) range from the family making the decision mainly, through a collaborative model where the family and patient jointly decided, to a scenario where the patient made decision mainly. Family is asked to indicate whether they preferred an independent role (i.e., "that the family makes the final decision regarding which treatment the patient will receive or after considering patient's opinion"), shared role (i.e., "that the family and patient together select which treatment is best for the patient"), or a dependent role (i.e., "that the patient alone makes all the decisions regarding the patient's treatment or considers the family's opinion"). Family participant chose the decision-role statement that best described his/her preferred role in decision making. The Control Preference Scale (CPS) is translated into Korean by two bilingual individuals, using a forward-backward translation procedure, and completed pilot test.

Levels of family anxiety and depression is assessed by the Hospital Anxiety and Depression Scale which consists of 14 items, seven on anxiety and seven on depression, forming two sub-scales. Each item has four descriptive response options to be scored on a 0 to 3 scale. A value of 0 corresponds to not having the symptom, 3 corresponds to having the symptom to a high level. Scores for each of the two sub-scales are constructed by simple summation of its seven items. The developers have suggested that sub-scale scores of 0-7 represent non-cases, 8-10 represent doubtful cases, and 11-21 represent definite cases.

The Baseline Patient's Generic QOL:. Because we expect the effect of intervention for family to accompany change of patients' outcome, we measure patients' QOL and quality cancer care at baseline to observe secondary outcome related with effect of the decision aid.

Patient's QOL is assessed with QCQ-EOL. To correct possible confounders in this study, patient' background variables are obtained on entry to the study including sociodemographic and medical records.

Outcome Measures:

The primary outcome to be considered is the potential efficacy of this aid including family's decisional conflicts, satisfaction with decision making, and decisional-role preference, decisional regret, and physician and family acceptance of the decision aid.

Family satisfaction with decision making is assessed using the effective decision-making subscale of the decisional conflict instrument \[O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30\]. The subscale was four items regarding satisfaction with decision making (being informed, reflection of participant's own values, likelihood to comply, and satisfied). Scores for family satisfaction are reversed so that the higher scores reflect higher level of satisfaction (ie, a reversed Likert scale in which 5 is the highest scored). A mean score is obtained for each patient.

Physician and participant's acceptance of the decision aid is addressed using two questionnaires followed by a Likert response of 1, strongly agree, to 5, strongly disagree (i.e., family assessment item, "The decision support was useful to me in reaching a decision", "I would recommend that others facing the decision use the support", "The decision support interfered with my relationship with patient", Physician assessment item, "I feel the family has made an informed choice", "The decision support was useful in helping this family understand the risk and benefits of the disclosure on terminal illness", "The decision support did not interfere with my anticipated physician-patient relationship with my patient")\[Brundage et al2001\]. Decision regret is measured by the Decision Regret Scale which is useful tool for measuring regret after decisions at a particular point in time developed by O'Connor et al. It consists of 5 items followed by a Likert response of 1, strongly agree, to 5, strongly disagree. The definition of decision regret is remorse or distress over a decision\[O'Connor\]. These items were whether regret was felt to be present, whether the decision was the right one for him/her, whether he/she would make same decision again in the same circumstances, whether the decision was a wise one, and whether the decision had resulted in harm. The Decision Regret Scale is translated into Korean by two bilingual individuals, using a forward-backward translation procedure, and completed pilot test.

Secondary outcomes include the levels of family anxiety and depression,and family's QOL.

Levels of family anxiety and depression is assessed with the Hospital Anxiety Depression Scale. The actual disclosure following use of the material is assessed by following items including chosen disclosure and if terminal illness disclosed "who, and when disclose patients' terminal condition" and it is assessed at 1, 3, and 6 months after sending the material. Levels of family anxiety and depression, family decision regret, family preference for role in decision making, and patient's QOL are assessed at 1, 3, and 6 months after sending the video.

Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness

Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness to Patient With Terminal Cancer

National Cancer Center, Korea

Division of cancer control

Disease Progression

Parenteral nutrition treatment in palliative care

Parenteral nutrition

Trude Rakel Balstad, phd

Torstein Baade Rø, md phd

Arne Solberg, md phd

Parenteral nutrition (PN) treatment in patients with incurable cancer is understudied and the level of evidence for clinical meaningful effects is weak. Guidelines give few specific recommendations regarding which patients with incurable cancer that should be offered PN treatment. According to the Norwegian prescription database, the use of parenteral nutrition has more than doubled in the period 2004-2015. These numbers do not separate between diagnoses and medical conditions, so the current use of medical nutrition in cancer patients in Norway is not known. The decision to initiate parenteral nutrition is taken at hospitals, whereupon the patient returns home to their respective municipalities and receives follow-up by the home care service. There are often uncertainties about the duration of treatment, as patients' clinical condition can change rapidly. One major challenge health care professionals face is to decide when to end medical nutrition therapy. Patients and relatives may experience fear that discontinuation of medical nutrition accelerates death, while health care professionals often experience that nutrition in many cases does not help and inflicts negatively on patients' condition. This makes communication concerning end of nutritional treatment between health care professionals at several health care levels, patients and their relatives challenging.

There is a need for a stronger evidence base considering the effect of medical nutrition in patients with incurable cancer. To be able to study the effect of PN treatment, more studies on clinical practice of PN treatment to patients with incurable cancer is needed. Aspects like indication for use, dosage and duration of PN treatment is poorly described in the available literature. Thus, the aim of this study is to describe indications for use of PN, duration of treatment, reasons for discontinuation, method of administration, possible benefits and complications as well as survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using an End-of-life Conversation Game to Engage Patients With Cancer in Advance Care Planning	NCT06028152	Breast Cancer Lung Cancer Genito Urinary ...	End-of-life con...	18 Years -	Milton S. Hershey Medical Center
GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.	NCT04942756	Palliative Care Diabetes Mellit... Diabetes Mellit... Diabetes Cancer Terminal Cancer Terminal Illnes... End Stage Cance... Advanced Cancer	Continuous Gluc... Standard Care	18 Years -	Antea Foundation
Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks	NCT03336489	Neoplasms Neurodegenerati... Terminal Illnes...		18 Years -	Fondation Ophtalmologique Adolphe de Rothschild
Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students	NCT03041571	Narrative Medic... Chronic Disease Terminal Illnes... Cancer Diabetes Mellit... Cystic Fibrosis Rheumatologic D... Oncologic Disor... Hematologic Dis...	Patient Provide... Interview perfo...	8 Years - 100 Years	University of Florida
Evaluation of the Organization of Continuity of Care for Home Hospice Patients by Four Parisian Health Networks	NCT03336489	Neoplasms Neurodegenerati... Terminal Illnes...		18 Years -	Fondation Ophtalmologique Adolphe de Rothschild
Differences in Acceptability of Music Therapy Sessions Played Live Compared to a Recording Thereof	NCT06108375	Terminal Illnes... Terminal Cancer	music therapy recording	18 Years -	University of Zurich
Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness	NCT00686673	Terminal Illnes...	Providing tailo... Providing non-t...	18 Years -	National Cancer Center, Korea
Parenteral Nutrition Therapy in Patients With Incurable Cancer	NCT04456647	Neoplasms Terminal Illnes...	Parenteral nutr...	18 Years -	Norwegian University of Science and Technology
Effect of a Decision Aid on Decision Making for Family Member's Disclosure of Terminal Illness	NCT00686673	Terminal Illnes...	Providing tailo... Providing non-t...	18 Years -	National Cancer Center, Korea

Spots Global Cancer Trial Database for terminal illness