Antineoplastic Agents

All Drugs and Chemicals

Angiogenesis Inhibitors

Once weekly, one hour IV infusion of PG545.

PG545 will be administered once weekly, as a one hour IV infusion. Patients will be treated until they exhibit disease progression, withdraw due to poor tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 250 mg anticipated.

PG545

Michael Millward, MBBS

This Phase Ia study aims to establish the maximum tolerated dose of once-weekly IV infused PG545 and to evaluate its safety in subjects with advanced solid tumours. In addition, the study will explore whether PG545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.

Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours

An Open-label, Multi-centre Phase I Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours

The MTD will be determined by assessing dose limiting toxicities at the end of the first month's treatment. Dose escalation and de-escalation will continue until an MTD is identified. Each cohort of patients will receive weekly doses at a single dose level for the duration of the study.

Zucero Pty Ltd

Rare Diseases

All Conditions

Oculocerebral Syndrome With Hypopigmentation

Yves Libert, Ph.D

Lisa Choucroun, M.A.

Yves Libert, Ph.D.

Isabelle Libert, M.D.

Aurore Liénard, Ph.D.

Myriam Obiols, M.A.

Ahmad Awada, M.D., Ph.D.

Gabriel Liberale, M.D., Ph.D.

Nathalie Meuleman, M.D., Ph.D.

Dirk Van Gestel, M.D., Ph.D.

Isabelle Merckaert, Ph.D.

Advanced care planning (ACP) is a major component of end-of-life care. Advanced care planning aims to (1) establish treatment and care options in the event that continuing cancer treatment is more risky than beneficial (e.g., participating in a clinical trial testing a new treatment; continuing supportive care only) and (2) establish possible treatment limitations in the event that a medical complication threatens the patient's survival without the patient's expressed wishes (e.g., transfer to an intensive care unit; resuscitation). However, cancer patients still rarely engage with their physician(s) and family in a discussion about ACP. The primary objective of the project is to conduct a cross-sectional, observational study of the willingness of advanced cancer patients and their primary caregivers to communicate about ACP with each other and with the physician(s); and their agreement/disagreement with these respective willingness. The secondary objective of the project is to assess the medical, psychological and relational factors associated with these willingness. This study will involve 300 consecutive patient- primary caregiver-physician(s) triads. For each patient and their primary caregiver, an in-depth assessment of their willingness to communicate about ACP with each other and with the physician(s) will be conducted using specific scales. The medical, psychological and relational characteristics of the included patients and their primary caregiver will also be assessed using validated questionnaires. Results of this study will enable to propose innovative interventions likely to optimize the establishment of an ACP for numerous advanced cancer patients.

Advanced care planning (ACP) is a major component of end-of-life care. Advanced care planning aims to (1) establish treatment and care options in the event that continuing cancer treatment is more risky than beneficial (e.g., participating in a clinical trial testing a new treatment; continuing supportive care only) and (2) establish possible treatment limitations in the event that a medical complication threatens the patient's survival without the patient's expressed wishes (e.g., transfer to an intensive care unit; resuscitation). ACP aims to ensure that the patient receives care consistent with their personal values, life goals, and preferences. Nowadays, ACP is conceived as an iterative process of communication between patients, their families, and caregivers. However, cancer patients still rarely engage with their physician(s) and family in a discussion about ACP.

There is a gap between the recommendations that communication take place between patients, their families and physician(s) regarding end-of-life care planning, and the application of this recommendation in clinical practice. This gap threatens the quality of life care as well as the adjustment of their caregivers to this phase of the disease and the grief that follows. A thorough and rigorous study of the reasons for this discrepancy has become an essential issue for the oncology of tomorrow.

No studies have quantified the respective willingness of cancer patients and their primary caregivers to communicate about ACP with each other and with their physician(s). No studies have quantified the agreement/disagreement of these patients and their primary caregivers on this issue. No study has assessed the medical, psychological, and relational factors associated with these respective willingness and agreements/disagreements.

This is a cross-sectional observational study. On a weekly basis, the list of eligible patients having a consultation at the Institut Jules Bordet in the medical oncology, hematology, surgery or radiotherapy departments will be provided by the Institute's IT department. An audit of the patients' medical records will be performed by the evaluator. This check will ensure that the patient meets the study's eligibility criteria.

Each patient will be personally contacted by telephone by an evaluator to introduce the study and solicit their participation. During this contact, the patient will identify and provide, if desired, the contact information for their primary caregiver and the physician they designate as their primary decision-maker in the treatment and care of their cancer condition.

A psycho-oncologist evaluator will conduct the assessment for all the patients, their primary caregiver and their physician. This assessment is based on an integrative model of medical, psychological and relational factors associated with the willingness of patients and their relatives to communicate about the patient's ACP. This model has allowed the development of case report forms with different questionnaires. Informed consent forms will be provided by the evaluator, due to the sensitivity of the topics addressed. The questionnaires of the patient, their primary caregiver and their physician will be administered within one month of the first contact with the patient. A simultaneous evaluation will be conducted with patients and primary caregivers. The time difference between the questionnaires of the three protagonists involved in the study will not exceed 72 hours. The completion of the questionnaire will be assisted, in person or if necessary remotely, before the consultation. The survey will be administered using the REDCAP software.

The recruitment of patients, their primary caregiver and their physician will be done consecutively. This recruitment will continue until 300 patient - primary caregiver - physician triads are included in the study. The socio-demographic and medical information of the subjects for whom this evaluation could not be performed, as well as the reasons for this non-evaluation, will be recorded and archived in the study results.

This is the first study to address in a observational manner the willingness of the patient and their primary caregiver to communicate about ACP, their agreement/disagreement with these respective willingness, and the associated medical and relational psychological factors. The Institut Jules Bordet provides a framework for conducting a study, the results of which will allow optimization of the process of establishing an ACP. This optimization will improve the quality of life of these patients and their families. Conducting this study will provide suggestions for interventions that may optimize the establishment of a ACP for many cancer patients.

Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)

Cross-sectional, Observational Study of Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)

Willingness to communicate about patients' ACP is assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Willingness to communicate about the patient's ACP". The questionnaire is composed of 8 items regarding the willingness to communicate with each other and with the physician(s) about patients' planification of treatments, care, and the patient's prognosis. Each item has a 4 points Likert scale, ranging from "no" to "yes".

Advanced care wishes are assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "advanced care wishes". The questionnaire is composed of 12 items regarding advanced care preferences: participating in a clinical trial, receiving supportive care only, being resuscitated, being transferred to an intensive care unit. Each item has a 4 points Likert scale ranging from "no" to "yes".

Perceived self-efficacy to communicate about the patient's ACP is assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Perceived self-efficacy to communicate about the patient's ACP ". The questionnaire is composed of 4 items regarding the patient's and primary caregiver's perception of their efficacy to communicate with each other and with the physician(s) about patient's planification of treatments and care. Each item has a 4 points Likert scale ranging from "no" to "yes".

Barriers that prevent from communicating about the patient's ACP are assessed through a self-reported questionnaire created for the study and completed by the patients and their primary caregiver named "Barriers that prevent from communicating about the patient's ACP". The questionnaire is composed of 14 items regarding the potential barriers that prevent the patients and their primary caregiver from communicating with each other and with the physician(s) about the patient's planification of treatments and care: physical and/or psychological health, religious and/or philosophical beliefs, lack of time and/or availability of the physician(s). Each item has a 4 points Likert scale ranging from "no" to "yes".

Socio-demographic characteristics are assessed through a self-reported questionnaire created for the study and completed by the patient and the primary caregiver named "Socio-demographic characteristics". The questionnaire is composed of 14 to 20 items depending on the branching logic: age, gender, current language, cultural background, education and occupation, family status, current and/or previous role as primary or secondary caregiver in the context of a critical illness, previous or ongoing psychological and/or psychiatric support, prior completion of an advanced declaration for euthanasia and identification of a proxy.

Socio-professional characteristics are assessed through a self-reported questionnaire created for the study and completed by the physician named "Socio-professional characteristics". The questionnaire is composed of 9 to 11 items depending on the branching logic: age, gender, family status, occupation, clinical practice with advanced cancer patients, professional experience and training, prior completion of an advanced declaration of euthanasia.

Patients' current functional status is assessed wit the Palliative Performance Scale, composed of 11 items. The scale ranges from "100%" to "0%". A higher score reflects full ambulation, normal activity \& work, no evidence of disease, full self-care, normal intake, full conscious level.

Medical factors are extracted from the patient's chart by the investigator and reported on a specific questionnaire named "Medical characteristics". The questionnaire is composed of 29 items regarding medical history, diagnosis, stage of disease, previous and ongoing cancer treatments.

Perception of the patient's medical situation is assessed through a validated self-reported questionnaire adapted for the study and completed by the patients, their primary caregiver and physician(s) named "perception of the patient's medical situation". The questionnaire is composed of 2 to 10 items depending on the branching logic, assess the knowledge about a possibility of cure for the patient's cancer, as well as an estimation of the patient's prognosis.

Physician's communication about the patient's ACP is assessed through a self-reported questionnaire created for the study and completed by physicians named "Willingness to communicate about the patient's ACP". The questionnaire is composed of 2 items regarding the willingness to communicate with the patient's about his/her planification of care, and about his/her prognosis. Each item has a 4 points Likert scale, ranging from "no" to "yes".

Patient's and primary caregiver's emotional distress is assessed with the Hospital Anxiety and Depression Scale (HADS), a 14 items questionnaire, composed by two dimensions (anxiety and depression) and has a 4 point Likert scale that vary at each item. HADS provides a total score (0-42 range) by summing all item scores. A higher score reflects a higher emotional distress. Anxiety subscale score (0-21 range) is provided by summing all Anxiety-items. A higher score reflects more anxiety. Depression subscale scores (0-21 range) is provided by summing all Depression-items. A higher score reflects more depression.

Satisfaction with cancer care is assessed through a single item from the self-reported questionnaire EORTC QLQ-C-30 and a specific satisfaction questionnaire composed with 10 items and created for the study and completed by the patients and their primary caregiver. Each item has a 5 points Likert scale, ranging from "low" to "excellent".

Intolerance of Uncertainty is assessed through with the Intolerance of Uncertainty Scale - Short Form completed by patients, their primary caregivers, and physicians. This validated questionnaire is composed of 11 items. Each item has a 5 points Likert scale, ranging from "Not at all characteristic of me" to "Entirely characteristic of me".

Moral principles are assessed through a specific questionnaire of moral dilemma created for the study and completed by patients, their primary caregivers, and physicians. The questionnaire is composed of 4 items corresponding to four hypothetical situations of treatment choice, in which a choice has to be made between two courses of action, either of which entails transgressing the moral principle of autonomy. These situations are written with varying levels of uncertainty. Each item has 2 options: I accept or refuse the treatment.

Decision-making preferences regarding medical decisions are assessed through a validated self-reported questionnaire, the"Control Preference Scale" and completed by patients, their primary caregivers, and physicians. The questionnaire is composed of 2 items regarding who should make decisions regarding the patient's treatment or care (1) if his treatments are more harmful than beneficial, or (2) if in this context a life-threatening medical complication occurs, and the patient cannot express his wishes. Each item has a 7 points Likert scale, ranging from "decisions must be made by myself" to "decisions must be made by myself with my primary caregiver and my physician".

Perceived self-efficacy to communicate about the patient's ACP is assessed through a self-reported visual analog scale created for the study and completed by physicians named "Perceived self-efficacy to communicate about the patient's ACP". The questionnaire is composed of 3 Visual Analogic Scale (VAS) regarding the physicians' perception of their efficacy to communicate with the patients about their planification of treatments, care, and prognostic. Each VAS ranges from "not at all" to "completely".

Perceived communication about patients' ACP is assessed through a self-reported visual analog scales (VAS) questionnaire created for the study and completed by physicians named "Perceived communication about patients' ACP". The questionnaire is composed of 3 VAS regarding the stress that the physician may experience when communicating with cancer patients about their advanced care planning and prognostic. Each visual analog scale ranges from "not stressful at all" to "extremely stressful".

Perceived outcome expectancies regarding communication about patients' ACP is assessed through a self-reported questionnaire created for the study and completed by physicians named "Perceived communication about patients' ACP". The questionnaire is composed of 12 items regarding the probability of occurrence of specific consequences of the communication with patients about their advanced care planning and prognostic. These consequences are: helping the patients, compromising their coping with cancer, obtaining useful information, or feeling responsible for solving all the concerns expressed. Each has a 5 points Likert scale, ranging from "unlikely" to "very likely".

Collusion between patient and their caregiver is assessed through a specific questionnaire created for the study and completed by patients and their primary caregivers named "Collusion between patient and their caregiver". The questionnaire is composed of 2 items regarding the respective patient's and caregiver's willingness that the other communicate with the physician(s) about patient's planification of treatments and care. Each item has a 4 points Likert scale ranging from "no" to "yes".

Physician cognitive empathy is assessed through a specific questionnaire created for the study and completed by physicians named "physician's perception of patient's treatment choices". The questionnaire is composed of 1 item regarding the treatment choice the physician would make if he/she was currently in the patient's situation. This item has a 2 options: continuing treatments versus receiving supportive care only.

Physicians' burn out is assessed with the Maslach Burn Out Inventory (MBI). This validated inventory has three subscales: emotional exhaustion (9 items), depersonalization (5 items) and personal achievement (8 items). Each scale measures its own unique dimension of burnout, using 7 level frequency ratings from "never" to "daily". MBI provides a score on each dimension. A high score on the first two scales and a low score on the last one indicates burnout.

Relational factors are assessed through a specific questionnaire created for the study and completed by patients and their primary caregivers named "Relationship between the patient, the primary caregiver, and physician(s)". The questionnaire is composed of 6 items regarding: the relationship between the primary caregiver, the patient and the physicians; the time and frequency with which the caregiver helps the patient cope with cancer-related difficulties; the type of help the patient receives (informative, emotional, practical); the frequency with which the patient discusses cancer-related difficulties with the caregiver; date since the physician(s) took care of the patient; number of consultations between the physician(s) and the patient since the start of care.

Perceived daily burden is assessed through a self-reported visual analog scale (VAS) created for the study and completed by patients and their primary caregivers named "Perceived daily burden". The questionnaire is composed of 2 items regarding the feeling of being a burden and the feeling of having a burden. The visual analog scale ranges from "not at all" to "completely".

Fonds Gaston Ithier

Université Libre de Bruxelles

Association Jules Bordet

Jules Bordet Institute

Behaviors and Mental Disorders

Quality of Life

a life review program includes 3-session life review and formulation of a life review book as a gift for advanced cancer patients.

the subjects in the controlled group do not receive the life review program

The life review program includes reviewing a life and formalating a life booklet. Reviewing a life consists of three weekly sessions separately addressing illness experience, adulthood life and childhood and adolescence life. Each session lasts about 30 to 60mintues.A booklet with photos documented significant life events will be produced as a gift for the subjects. The edition, photos and contents fo the booklet are determined by the subjects.

a life review program

Enid Kwong, PhD

This study aims to develop a life review program and test its effectiveness on a sample of patients with advanced cancer patients receiving palliative care at home in Fuzhou.

A life review program is mainly developed based on Erickson's theory, Confucius's teaching on human development, and the empirical findings of the researcher's preliminary study and pre-pilot study. The program covers reviewing a life for advanced cancer patients and formulating a booklet for them. A randomized controlled trial will be adopted for evaluation of this program. Eligible patients will be randomly assigned to the experimental group and the control group. The subjects in the experimental group will receive a life review program for three weeks. The outcome measure is quality of life (QOL), including domains of physical discomfort, food-related concerns, health care concerns, support, negative emotions, sense of alienation, existential distress and value of life. Subjects' QOL will be assessed before commencement of the program (T0) and one day (T1) and three weeks (T2) after the completion of the program for all subjects in two groups. Perceptions of the program will be elicited within three days after the program for subjects in the experimental group.Descriptive statistics will be used to analyze patients' personal information, disease related information, functional performance and QOL of advanced cancer patients. Repeated measures ANOVA will be used to measure QOL differences in between-group, within-group and interaction effects. Content analysis will be used to analyze the qualitative data collected.

Intervention Study on Life Review Among Advanced Cancer Patients in Fuzhou, China

Development and Evaluation of a Life Review Program for Advanced Cancer Patients in Fuzhou, China

The Hong Kong Polytechnic University

Enid Kwong

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Wen-Yuan Lin, M.D.

Cachectic patients often lose their appetite, lose weight, and are prone to weakness and even death in advanced illness. Nutrition therapy is important and of concern to the investigators in cancer patients. More than 80% of terminal cancer or advanced illness patients get cachexia. Cachexia is a complex, multifactorial syndrome that results from a reduction in food intake, a variety of metabolic abnormalities (including hypermetabolism) or more often a combination of the two. Cachexia will progress with disease progression. Cachexia or weight loss is often the major cause of death or poor quality of life.

The change of resting energy expenditure (REE) is different in various tumor types. Most experts agree that the REE will increase in cancer cachexia syndrome. The more weight loss, the more cachexia will occur.

Overnutrition is not beneficial in terminal patients according to the Chiu and Easson studies. As the investigators know, few studies focus on REE in terminal patients. In this study, samples are from a hospice palliative ward or from hospice home care patients in a medical center in mid-Taiwan. About 100 patients will be recruited. The investigators will analyze the relationship between REE and its related factors. After finishing the study, they will provide more evidence for treating cachexia in terminal patients.

According to data from the Taiwanese government, cancer mortality has been the leading cause of death in Taiwan since 1982. The trend is increasing day by day. As the people are aging in Taiwan, the incidence of cancer will increase and it will be more important than before.

Cachectic patients often lose their appetite, lose weight, and are prone to weakness and even death in advanced illness. Nutrition therapy is important and of concern to the investigators in cancer patients. More than 80% of terminal cancer or advanced illness patients get cachexia. Cachexia is a complex, multifactorial syndrome that results from a reduction in food intake, a variety of metabolic abnormalities (including hypermetabolism) or more often a combination of the two. Cachexia will progress with disease progression. Cachexia or weight loss is often the major cause of death or poor quality of life.

The change of resting energy expenditure (REE) is different in various tumor types. Most experts agree that the REE will increase in cancer cachexia syndrome. The more weight loss, the more cachexia will occur.

Overnutrition is not beneficial in terminal patients according to the Chiu and Easson studies. As the investigators know, few studies focus on REE in terminal patients. In this study, samples are from a hospice palliative ward or from hospice home care patients in a medical center in mid-Taiwan. About 100 patients will be recruited. The investigators will analyze the relationship between REE and its related factors. After finishing the study, they will provide more evidence for treating cachexia in terminal patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours	NCT02042781	Advanced Solid ...	PG545	18 Years -	Zucero Pty Ltd
Advanced Cancer Patients' and Their Primary Caregivers' Willingness to Communicate About Advance Care Planning (ACP)	NCT05426330	Advanced Cancer		18 Years - 100 Years	Jules Bordet Institute
Study of the Safety and Tolerability of IV Infused PG545 in Patients With Advanced Solid Tumours	NCT02042781	Advanced Solid ...	PG545	18 Years -	Zucero Pty Ltd
Intervention Study on Life Review Among Advanced Cancer Patients in Fuzhou, China	NCT00951262	Advanced Cancer	a life review p...	18 Years -	The Hong Kong Polytechnic University
Intervention Study on Life Review Among Advanced Cancer Patients in Fuzhou, China	NCT00951262	Advanced Cancer	a life review p...	18 Years -	The Hong Kong Polytechnic University
The Survey About Resting Metabolic Rate and Its Related Factors in Terminal Patients	NCT00208013	Advanced Cancer...		-	China Medical University Hospital

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