Neoplasms

Digestive System Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Lung Neoplasms

Pancreatic Neoplasms

Melanoma

Glioblastoma

Death

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neoplasms, Glandular and Epithelial

Stomach Diseases

Stomach Cancer

Pancreatic Cancer

Neuroepithelioma

Oncologists trained using OncoTalk to have Goals of Care discussions.

Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

GoC intervention

Nina Bickell, MD, MPH

The goal of this study is to increase and improve Goals of Care discussions for advanced cancer patients by training medical oncologists to conduct these discussions. The investigators will evaluate the GoC discussion's effects on patient satisfaction, receipt of treatment in line with preferences, use of aggressive treatment, and oncologist communication skill.

Among advanced cancer patients, discussions about prognosis, goals of care (GoC) and end-of-life preferences improve quality of life of patients and reduce rates of hospital and ICU admission. Yet, few patients know their chemotherapy treatments will not cure their disease despite nearly all wishing to receive information- good \& bad. Currently, 37% of advanced cancer patients have GoC clarifying discussions and when they do, it is often in the last 2 months of life when symptoms are uncontrollable and oncologists have no other treatments to offer. These discussions do not usually happen with the patient's personal oncologist. Current efforts to teach oncologists such skills are impractical, requiring a lot of time away from their office practice and do not take into account job pressures.

The goal of this study is to increase and improve GoC discussions for advanced cancer patients by training medical oncologists to conduct these discussions and evaluate its effects on patient satisfaction, receipt of care in line with preferences, aggressive care utilization, and oncologist communication skill.

The investigators will recruit 280 patients of which half will come from intervention doctors and the other from the control doctors. The investigators will train randomly selected oncologists to conduct GoC discussion. Patients will be surveyed at baseline within days of their GOC visit and at 6 months. Oncologists will be audio-taped at baseline and after training is complete to assess practice and skill to conduct GoC discussions.

Primary outcomes include patient reported conduct of and satisfaction with GoC discussion. Secondary outcomes include oncologist communication skills, feasibility of performing GoC in the outpatient setting, receipt of care in line with preferences, use of hospice, chemotherapy or ICU in the last 30 days of life.

Improving Goals of Care Discussion in Advanced Cancer Patients

Improving Advanced Cancer Patient-Centered Care by Enabling Goals of Care Discussions

Number of patient's perceptions that goals of care discussions were increased occurred as measured by GoC qualitative patient survey.

Number of Patient's satisfaction with the discussion of improved goals of care as measured by GoC qualitative patient survey.

Oncologist's communication skills are tested and rated between 1 and 7, with higher number indicating the oncologists were more comfortable in demonstrating communication skills while having the Goals of Care discussion with their patients.

Patient-Centered Outcomes Research Institute

Icahn School of Medicine at Mount Sinai

Adverse events were not monitored/assessed

Patients given OncoTalk GoC intervention

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Patients - GoC Intervention

Prospective control group where no intervention was given.

Patients - Usual Care

Oncologists - GoC Intervention

Oncologists not trained using OncoTalk to have Goals of Care discussions.

Oncologists - Usual Care

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Data was collected for patient participants only

Radhi Yagnik

Oncologist - GoC Intervention

Data from patient participants only. Data not collected from Oncologists

Number of Participants Who Perceived Increased Goals of Care Discussions

Patients given OncoTalk GoC intervention.

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Data collected for patient participants only

Number of Patients Perception of Improved Goals of Care Discussions

Oncologists trained using OncoTalk to have Goals of Care discussions.

GoC intervention: Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.

Participants represented are the oncologist's. Data collected for the oncologists only.

Communication Skills Training

Overall Study

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Emergencies

Heart Failure

Kidney Diseases

Neoplasm Metastasis

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Renal Insufficiency, Chronic

Renal Insufficiency

Heart Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Respiratory Tract Diseases

Disease Attributes

Chronic Disease

Chronic Graft Versus Host Disease

The intervention will take place in the emergency department or days after an emergency department visit at home/hospital virtually using zoom or phone by our trained clinicians. At the time of follow-up assessments, participants may also receive additional counseling by our trained clinicians as needed.

No intervention will be conducted (standard of care).

The emergency department clinician-led, behavioral intervention (ED GOAL) is designed to engage seriously ill yet clinically stable older adults in the emergency department to address their values and preferences towards end-of-life care with their outpatient clinicians. The intervention consists of an interview to discuss participants' values and preferences for end-of-life care. The participants will receive coaching on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and outpatient clinicians. The participants' outpatient clinicians will also receive a summary of what participants disclosed via email or mailed letter.

ED GOAL

Kei Ouchi, MD, MPH

This is a two-armed, parallel-design, pre-/post-intervention assessment study. The investigators will conduct a randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect patient-centered outcomes and determine preliminary efficacy on increasing advance care planning engagement (self-reported and/or in the electronic medical record) one month after leaving the emergency department. The investigators will also conduct qualitative interviews with participants of ED GOAL.

ED GOAL, a 6-minute motivational interview conducted in the emergency department (ED), which engages participants to address advance care planning (ACP) conversations with their outpatient clinicians and avoids a time-consuming, sensitive conversation in the time-pressured ED environment. This study is designed to determine the preliminary efficacy of ED GOAL on increasing ACP engagement (by self-report and in the electronic medical record) one month after leaving the ED.

Advance Care Planning in the Emergency Department

An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial

ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome.

Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.

A validated instrument for seriously ill patients to report how well they feel heard and understood about their wishes for end-of-life care. This instrument is a 5-point Likert scale: "not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)." A higher score indicates a better outcome.

Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group, Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17. PMID: 26596879.

A validated instrument to measure the quality of communication about end-of-life care. This instrument is a 10-point Likert scale ranging from "the very worse I could imagine (0)" to "the very best I could imagine (10)". A higher score indicates a better outcome.

Engelberg RA, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98.

Electronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.

The electronic medical records will be reviewed to find the patients' vital status.

Semi-structured interviews to assess the benefits of ED GOAL and obstacles participants faced in completing more ACP conversations with their outpatient clinicians and loved ones after ED GOAL.

The electronic medical record will be reviewed to find clinician documentation of ACP conversations.

Participants are asked if they had completed ACP conversations with their loved ones and clinicians.

Brigham and Women's Hospital

Assistant Professor of Emergency Medicine

Patients over 60 years old with advanced, incurable cancer.

This care planning framework aims to implement existing tools in geriatric medicine, palliative medicine, and medical oncology to aid in cancer care planning for older adults with newly diagnosed incurable advanced cancer and to test the delivery of goal-concordant care. This patient-centered intervention is the ABC123 care planning framework in parallel with usual care that includes a physical function assessment, chemotherapy toxicity estimate calculation, and a guided goals of care discussion.

ABC123 Framework

Elizabeth Kessler

Pilot study assessing the feasibility and acceptability of the ABC123 framework, as well as goal concordance between patient and clinician stated goals. Patients \>60 years old with recently diagnosed advanced, incurable cancer in for a first consultation at a participating medical oncology clinic. The team will pilot test the ABC123 framework delivery by an advanced practice provider working with a medical oncologist to inform the overall care planning process. This framework will routinely incorporate and implement existing resources from these 3 transdisciplinary tenets (geriatric, oncology, and palliative medicine) into initial care planning in a patient-centered manner. The team will follow patients from initial care planning to 6 months post-intervention and assess additional stakeholder feedback on barriers and facilitators to implementation.

The ABC123 care planning framework is aimed at increasing care alignment delivered to older patients with advanced cancer by combining existing tools that represent the principles of geriatrics, oncology, and palliative care. In this pilot study, our primary goals are to assess the feasibility and acceptability of the ABC123 care planning framework and evaluate the framework's impact on the provision of care that aligns with the goals and values of patients. Participants will participate in a series of visits and follow-ups meant to implement and evaluate the ABC123 care planning framework that will take place over the course of six months. The first two visits will consist of 1) a short physical performance battery (SPPB) and estimation of potential for grade 3 chemotherapy toxicity using the Cancer and Aging Research Group chemotherapy toxicity calculator and 2) guided goals of care discussion with an Advanced Practice Provider based on the findings from visit 1. During 1, 3, and 6-month follow-up sessions, participants will complete a survey consisting of several commonly used questionnaires and an interview about experiences and goals. Care providers and institutional stakeholders will also be interviewed at 1, 2, and 3 years after initial implementation to understand experiences and assess the feasibility if the ABC123 framework.

Care Planning Framework in Advanced Cancer (ABC123)

Feasibility and Acceptability of the ABC123 Framework for Advanced Cancer Care

Recruitment (proportion of those approached who actually enroll)

Retention number of those completing both clinic sessions

Retention number of those completing both sessions, and follow up

American Cancer Society, Inc.

University of Colorado, Denver

Breast Neoplasms

Family caregivers of breast cancer patients who consent to participate in the study have a 50/50 chance of being randomized to the intervention group and will receive the booklet, Managing Cancer Care: A Caregiver's Guide (MCC-CG) (N=18)

Family caregivers of breast cancer patients who consent to participate in the study have a 50/50 chance of being randomized to the control group and will receive the Symptom Management Toolkit (N=17)

MCC-CG is a set of 7 printed modules including information about caregiver-nominated SM topics, conversation starters to facilitate communication with patients and providers, and links to caregiver resources. The modules are as follows:

1. Becoming a Cancer Caregiver \[role, changes, challenges, adjusting, self-care\]
2. Basics of Cancer Caregiving \[physical, functional, emotional, social, \& spiritual support; treatment timeline worksheet\]
3. Caregiver's Role in Managing Patient Care \[who/what is involved; health care professionals worksheet\]
4. Managing Cancer Symptoms and Side Effects \[common symptoms/side effects; maintaining health; nutrition \& exercise; medication management worksheet\]
5. Care Options: \[information on curative, palliative and hospice care\]
6. Talking About Goals of Care \[information on goals of care conversations\]
7. Managing Transitions \[defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet\]

Managing Cancer Care: A Caregiver's Guide

Along with an overview of symptom management, the Toolkit provides concise information on commonly experienced symptoms, including fatigue, alopecia, cognitive dysfunction, nausea and vomiting, and sleep problems, among others. Each chapter uses a question-and-answer format to cover the topics of who is most likely to experience the symptom, when and why the symptom may occur, how the symptom can be managed, and when to call a provider. Drs. Schulman-Green and McCorkle have previously tested the Symptom Toolkit in an attention-control group.

Symptom Management Toolkit

Dena J Schulman-Green, PhD

The purpose of this two-year mixed methods study is to develop and test an intervention to improve cancer family caregivers' knowledge of care options (curative, palliative, and hospice care) and goals of care communication as part of a self-management (SM) training program.

The two specific aims of this project are to:

1. Develop a psycho-educational intervention called Managing Cancer Care: A Caregiver's Guide (MCC-CG), for family caregivers of patients with breast cancer to increase knowledge of care options, goals of care communication, and other SM skills.
2. Evaluate the feasibility and preliminary efficacy of the MCC-CG in a pilot randomized controlled trial compared with an attention-control condition (symptom management education) on knowledge of care options, goals of care communication, and other key SM skills (engagement in SM, management of transitions and uncertainty, increasing self-efficacy, appropriate use of health care resources).

The investigators will address and accomplish aim 1 by taking the following steps:

1. Conduct development focus groups with family caregivers of women with breast cancer.
2. Develop the MCC-CG intervention prototype.
3. Conduct feedback focus groups with family caregivers to evaluate the prototype.
4. Revise the MCC-CG.

To address and accomplish aim 2, the investigators will do the following:

1. Conduct a pilot RCT to evaluate the feasibility of recruiting and retaining a sample of family caregivers.
2. Assess the initial efficacy of the MCC-CG to improve knowledge of care options, goals of care communication, and other SM skills.
3. Estimate power and determine the best measures for a large RCT testing the MCC-PT and MCC-CG together.

Improving Cancer Family Caregivers' Knowledge and Communication About Care Options

Includes demographic data for caregivers and clinical data for the patient whom they provide care for.

Data is abstracted from participants' medical records, including use of the emergency room, unscheduled hospital admissions, admission to ICU, use of chemotherapy and radiation in the last two weeks of life, and referral to hospice, among other indicators of disease burden as specified by the Center to Advance Palliative Care.

11-item questionnaire in true/false format to assess knowledge of curative, palliative, and hospice care.

Adjusted to reflect views of the family caregiver, the MCCS will assess participants' communication skills, including information seeking, providing, and verifying, and socio-emotional communication will be measured using the MCCS. Each item on the MCCS is presented with a Likert scale ranging from 7 (strongly agree) to 1 (strongly disagree).

The 33-item ECSMAS was developed to measure cancer patients' self-reported self-management. The ECSMAS is organized around three conceptual domains derived from a metasynthesis of process of self-management in chronic illness: focus on illness needs, activating resources, and living with chronic illness. Items are adjusted to reflect views of the family caregiver, and an additional item has been added to the ECSMAS to assess caregivers' ability to manage transitions as a self-management skill (34 items total).

This form documents frequency, perceived quality, and content of goals of care conversations with patients and providers, as well as capturing any transitions experienced.

This 22-item scale was developed to assess the experience of burden among caregivers, specifically addressing the dimensions of personal strain and role strain. Each item is presented with five response options ranging from 0-4 indicating "never", "rarely", "sometimes", "frequently", and "nearly always" sequentially.

Uncertainty will be measured using the 32-item MUIS, which was developed to measure the uncertainty adults perceive regarding symptoms, diagnosis, relationships, and planning for the future. Each item on the MUIS represents uncertainty in terms of a 5-point Likert-type format ranging from 1 (strongly disagree) to 5 (strongly agree). All items adjusted to reflect views of the caregiver.

Self-efficacy will be measured using a 4-point Likert scale, with four questions total.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Goals of Care Discussion in Advanced Cancer Patients	NCT02374255	Primary Stage I... Esophageal Colorectal Canc... Glioblastoma Cancer of Stoma... Cancer of Pancr... Melanoma Head or Neck Ca... Stage III Stage IV Lung Cancers Pancreatic Canc...	GoC interventio...	21 Years -	Icahn School of Medicine at Mount Sinai
Advance Care Planning in the Emergency Department	NCT05209880	Congestive Hear... Metastatic Canc... Chronic Kidney ... Chronic Obstruc...	ED GOAL	18 Years -	Brigham and Women's Hospital
Advance Care Planning in the Emergency Department	NCT05209880	Congestive Hear... Metastatic Canc... Chronic Kidney ... Chronic Obstruc...	ED GOAL	18 Years -	Brigham and Women's Hospital
Care Planning Framework in Advanced Cancer (ABC123)	NCT05408507	Advanced Cancer	ABC123 Framewor...	60 Years -	University of Colorado, Denver
Improving Goals of Care Discussion in Advanced Cancer Patients	NCT02374255	Primary Stage I... Esophageal Colorectal Canc... Glioblastoma Cancer of Stoma... Cancer of Pancr... Melanoma Head or Neck Ca... Stage III Stage IV Lung Cancers Pancreatic Canc...	GoC interventio...	21 Years -	Icahn School of Medicine at Mount Sinai
Improving Cancer Family Caregivers' Knowledge and Communication About Care Options	NCT02616107	Family Caregive...	Managing Cancer... Symptom Managem...	18 Years - 110 Years	Yale University

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