Symptoms and General Pathology

All Conditions

Death

Interviewees: terminally ill patients, families and healthcare providers of such patients

Not Application as this is a qualitative study

Joyce Chung, PhD

Weilin Chen, Master

The goal of this observational study is to explore experiences and perceptions of end-of-life communication in Chinese terminally ill patients, families and healthcare providers. The main question it aims to answer is:

• What are the experiences and perceptions of end-of-life communication in Chinese terminally ill patients, families and healthcare providers? Participants will be invited to either semi-structured in-depth interviews or focus group discussions to share their thoughts.

Objectives: To explore stakeholders' (patients, families and healthcare providers) experiences and perceptions of end-of-life communication in China; and understand culturally appropriate communication strategies.

Design and subjects: This study is a qualitative study. Eligible patients, family caregivers and healthcare providers will be recruited in two hospitals. Purposive sampling methods will be adopted. Semi-structured in-depth interviews with patients and family caregivers will be conducted respectively. Focus group discussions will be arranged with healthcare providers, allowing them to discuss end-of-life communication and generate group interactions and creative thinking.

Data analysis: The data analysis will be an iterative, cyclic and self-reflective process. Using inductive thematic analysis, common themes and categories will be determined through inductive reasoning and constant comparison.

Expected results: The study will fill the gap of no empirical evidence on end-of-life communication strategies from a Chinese perspective and enrich the knowledge about end-of-life communication.

End-of-life Communication From a Chinese Perspective

Development and Evaluation of a Culturally Specific End-of-life Communication Skills Training for Chinese Oncology Nurses

Interviews and focus group discussions will be conducted to collect qualitative data

The Hong Kong Polytechnic University

Assistant Professor, School of Nursing

The IG will receive the end-of-life CST between the two measurement points

The CG will be a waitlist group and receive the training after the end of data collection.

Training methods include lectures, video demonstrations, and simulation in small groups (4-5 trainees per group with multidisciplinary roles). Written and audiovisual learning materials will be offered. Each session will be 150 minutes, including lectures and video demonstration (90 min/session) and simulation and feedback (60 min/session). One session will be conducted in two weeks. Totally there will be four sessions completed in 8 weeks.

The end-of-life communication skills training

Routine training activities arranged by relevant departments in hospitals

Routine training activity

The goal of this clinical trial is to evaluate the effectiveness of culturally specific end-of-life communication skills training (CST) among Chinese oncology nurses.

The main question it aims to answer is: What is the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses? Participants will receive an 8-week communication skills training. Researchers will compare the intervention group and the wait-list group to see if skills, self-efficacy, and outcome expectancy beliefs will be improved.

Objectives: The study aims to evaluate the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses.

Design and participants: It is designed as a single-blind, pre-post randomized controlled trial (RCT). Registered nurses who work with advanced cancer patients in hospital settings will be recruited. The participants will be randomly assigned to either the intervention group (IG) or the control group (CG). The IG will receive the end-of-life CST between the two measurement points, and the CG will be a waitlist group and receive the training after the end of data collection.

Data analysis: Demographic information about the participants will be summarised in descriptive statistics. Independent t-tests and chi-square tests are used to investigate the comparability of groups in terms of the demographics generated by randomization. The primary and secondary outcome variables will be examined using covariate-adjusted linear mixed models. This approach enables the consideration of missing data. For non-repeated continuous measurements, ordinary linear regression and logistic models will be adopted. The intention-to-treat (ITT) analysis and post hoc analyses of contaminated data will be performed.

Expected results: Nurses' skills, self-efficacy, and outcome expectancy beliefs will improve after the CST.

The IG will receive the end-of-life CST between the two measurement points, and the CG will be a waitlist group and receive the training after the end of data collection.

A Culturally Specific End-of-life Communication Skills Training

Effects of a Culturally Specific End-of-life Communication Skills Training for Chinese Oncology Nurses

Self-developed items and open questions anout the training experience

Measured by Nurses' Clinic Communication Competency Scale, a 58-item self-reported scale which measures six dimensions. A 5-point Likert scale from (1) very poor to (5) very good is used. Higher scores mean a better outcome.

Measured by Hospice Care Self-efficacy Scale on nurses, a 12 items with a 5-point Likert scale from (1) very diffident to (5) very confident. Higher scores mean a better outcome.

Measured by The Communication Outcomes Questionnaire, a 23-item self-report questionnaire with a 9-point Likert scale from 1 = very likely and 9 = very unlikely. Higher scores mean a worse outcome.

Nervous System Diseases

Pain

Pain, Intractable

Neurologic Manifestations

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics, Opioid

Substance P

Neurokinin A

Neurotransmitter Agents

The first subject will be enrolled in the 1-mcg SP-SAP cohort. A percutaneous intraspinal catheter will be placed at the L5-S1 interspace and the catheter advanced 4-5 cm into the intrathecal space under fluoroscopic guidance. To confirm location, CSF will be aspirated and radioopaque contrast dye injected. 1-mL study drug will be mixed with 1-mL patient CSF fluid and administered intrathecally via the catheter. The catheter will be flushed with 1 mL bolus of saline. Four hours after injection (+15 min), the catheter will be removed and the exit site treated with Neosporin ointment and sterilely dressed. Subjects will be monitored in the recovery room for 4 hours and in the hospital for 24 hours and discharged home. Patients only receive a single IT dose.

Substance P-Saporin

Arthur Frankel, MD

The subjects will be treated with a single dose of SP-SAP. They will receive the study drug SP-SAP via a percutaneous intraspinal catheter, they will be monitored for 4 hours and required to stay in the hospital for 24 hours for precautionary care. Their vital signs will be monitored and recorded immediately following the injection. After the catheter has been removed, the following assessments will be made physical exam including motor and sensory functions, and electrocardiogram. A neurologist will be available for consultation as needed.

Beginning dose of SP-SAP will be 1 -mcg for the first cohort.

Subsequent single patient dose cohorts as 2, 4, 8, 16, 32, 64 and 90 mcg intrathecally (into the spine). SP-SAP will be accrued and treated after four weeks observation for toxicities between cohorts.

Study duration will be up to 6 months from the start of SP-SAP administration.

Screening (-7 days to Day 0)

* Physical exam and medical history;
* Vital signs;
* Blood tests;
* Pain measurements (6 daily pain questionnaires for 7 days prior to receiving study drug);
* Urine tests;
* Pregnancy test;
* Electrocardiogram (EKG), a tracing of the electrical activity of the heart;
* Collection of demographic information (age, sex, ethnic origin);

Study Drug:

SP-SAP will be administered via a spinal injection. Depending on when the subject is enrolled in the study, the dose of SP-SAP will be between 1 and 90 micrograms of SP-SAP

Therapy:

Subject will arrive at the UTSW Eugene McDermott Center for Pain Management 2 hours prior to treatment. The following will take place:

* Physical exam;
* Pain measurements (6 pain questionnaires);
* EKG;
* The subject will have a catheter inserted into their spine and will receive the study drug intrathecally (into their spine). The catheter will remain in their spine for 4 hours. Less than 1 tablespoon of spinal fluid will be collected for research purposes; and
* They will remain in the University of Texas Southwestern Medical Center Hospital for 24 hours for observation as a precaution.

Follow-Up will occur weekly for 8 weeks and then monthly for 4 months as needed.

During these visits the following will take place:

* Physical exam (including sensory and motor skills) and medical history;
* Vital signs;
* Two tablespoons of blood will be drawn from your arm by needle stick for blood tests;
* Pain measurements (6 pain questionnaires);
* Urine tests; and
* Electrocardiogram (EKG), a tracing of the electrical activity of the heart.

The subject will be asked to keep a diary to record any nausea and vomiting as well as a medication log to record the pain medications and dosage that they take between visits.

Each visit will take approximately 2 hours to complete

4 Month Follow-Up Informational data on the level of pain, adverse events, and sensory and motor function will be collected for the remaining 4 months of the study or until time of death. This information may be collected via patient diary, office visit or telephone interview.

A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain

The response criteria are based on achievement of a 20% reduction in chronic pain or opioid dose within eight weeks of treatment as assessed by at least two of the measured parameters: VAS "pain bothersomeness." VAS "pain intensity," ODI, SF-36, EQ-5D, BDI, and medication use log. Safe doses of opioids will be determined by referring physician and symptoms are refractory if at maximal safe dose of opioids (not associated with severe side effects), the VAS score remains elevated above 3.

Analyses will be performed for all subjects having received at least one dose of study drug. The study will use the CTCAE version 4.0 for reporting of non-hematologic adverse events

University of Texas Southwestern Medical Center

A battery of questionnaires concerning your thoughts, opinions, and attitudes about your illness and outlook on life. In addition, we will ask to provide some background information about you and your illness. The questions will take approximately 30 to 45 minutes to complete. You fill out the questionnaire once only.

questionnaires

William Breitbart, MD

The purpose of this study is to develop an accurate and useful way of measuring patients' thoughts and feelings about hope and hopelessness as they relate to their illness. Doctors and psychologists from Memorial Sloan-Kettering Cancer Center, Calvary Hospital, the Peter MacCallum Cancer Centre, and Fordham University are working together to design a new measure. Findings from this research will help us study the nature of illness and develop improved methods of diagnosis and treatment. We hope what we learn from you will help us learn more about how to care better for patients with cancer and other severe illnesses.

Measuring Hope and Hopelessness in Cancer

Fordham University

Calvary Hospital, Bronx, NY

Peter MacCallum Cancer Centre, Australia

Memorial Sloan Kettering Cancer Center

Meaning Centered Group Psychotherapy (MCGP)

standardized Supportive Group Psychotherapy

this eight-week (1 ½ hour weekly sessions) Session 1 - Concepts of Meaning and Sources of Meaning Session 2 - Cancer and Meaning Session 3 - Meaning and Historical Context of Life Session 4 - Storytelling, Legacy Project (optional) Session 5 - Limitations and Finiteness of Life Session 6 - Responsibility, Creativity, Deeds Session 7 - Experience, Nature, Art, Humor Session 8 - Transitions, Goodbyes, Hopes for the Future

Meaning Centered Group Psychotherapy

The eight weekly 1 ½ hour sessions will focus on group discussion on a set of specific themes that emerge for patients coping with cancer. The session themes or topics will include such issues as: the discussion of strategies for coping with medical issues and procedures, communication with health care providers and issues related to family, friends, and occupational life.

Supportive Group Psychotherapy

The purpose of this study is to compare two types of group counseling for cancer patients: Meaning-Centered counseling and Supportive counseling. Many cancer patients seek counseling to help with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings. "Meaning-Centered" group counseling is intended to teach cancer patients how to maintain or even increase a sense of meaning and purpose in their lives, despite cancer. "Supportive" group counseling is intended to help you cope with cancer by giving you a place to express your feelings and get support from other cancer patients. The purpose of this study is to compare the benefits of these two types of counseling approaches for cancer patients.

To conduct a randomized controlled trial comparing the efficacy of Meaning-Centered Group Psychotherapy (MCGP) versus a standardized Supportive Group Psychotherapy (SGP) in reducing psychological distress (depression and anxiety), end-of-life despair (hopelessness, desire for hastened death, and suicidal ideation), and improving spiritual well-being and overall quality of life in a sample patients with advanced cancer.

To assess the relative impact of Meaning-Centered Group Psychotherapy on different aspects of spiritual well-being (e.g., a sense of meaning and purpose versus spirituality linked to religious faith).

To examine clinical and demographic variables that may correspond to differential responses to Meaning-Centered Group Psychotherapy (e.g., potential mediating and moderating influences such as illness severity, religion and religiosity, level of education, race/ethnicity, level of pre-intervention social support, presence of pain and physical symptom burden).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
End-of-life Communication From a Chinese Perspective	NCT05734781	Terminally Ill	Not Application...	18 Years -	The Hong Kong Polytechnic University
End-of-life Communication From a Chinese Perspective	NCT05734781	Terminally Ill	Not Application...	18 Years -	The Hong Kong Polytechnic University
A Culturally Specific End-of-life Communication Skills Training	NCT05888480	End-Of-Life	The end-of-life... Routine trainin...	18 Years -	The Hong Kong Polytechnic University
A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain	NCT02036281	Terminally Ill Histologically-... Pain, Intractab...	Substance P-Sap...	18 Years -	University of Texas Southwestern Medical Center
A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain	NCT02036281	Terminally Ill Histologically-... Pain, Intractab...	Substance P-Sap...	18 Years -	University of Texas Southwestern Medical Center
A Culturally Specific End-of-life Communication Skills Training	NCT05888480	End-Of-Life	The end-of-life... Routine trainin...	18 Years -	The Hong Kong Polytechnic University
A Phase 1 Study of Substance P-Saporin in Terminal Cancer Patients With Intractable Pain	NCT02036281	Terminally Ill Histologically-... Pain, Intractab...	Substance P-Sap...	18 Years -	University of Texas Southwestern Medical Center
Measuring Hope and Hopelessness in Cancer	NCT00581880	Advanced Cancer	questionnaires	18 Years -	Memorial Sloan Kettering Cancer Center
Randomized Controlled Trial of Group Psychotherapy Interventions for Cancer Patients	NCT00494910	Palliative Care	Meaning Centere... Supportive Grou...	21 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for terminally ill