Heart and Blood Diseases

All Conditions

Nervous System Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Heart Failure

Stroke

Syndrome

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Heart Diseases

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Chronic Graft Versus Host Disease

Advance care planning between primary care clinician and the patient/family using the Serious Illness Care Program (SICP)

Advance care planning between team members and the patient/family using the Serious Illness Care Program (SICP)

SICP includes the Serious Illness Conversation Guide, which provides patient-tested language for initial and follow-up conversations; training materials, including didactic materials and case studies for structured role playing; and implementation guidance including recommended approaches to identifying appropriate patients and templates for documentation of conversations

Serious Illness Care Program (SICP)

Annette Totten, PhD

France Legare, MD, PhD

This project compares two models of the Serious Illness Care Program (SICP) in primary care: clinician-focused SICP and team-based SICP. Discussion and planning for serious illness care can help patients identify what is most important to them and assure they receive care that best matches their goals and values, such as spending more time at home or not being in pain.

Background and Significance:

Many people die after living with chronic conditions that have a broadly predictable course. This should give patients and families the opportunity to consider what is most important to them and plan for the care they wish to receive in their final months and at the end of life. However, in many cases health care defaults to more testing and treatments, creating a potential mismatch between healthcare services and what patients and families want.

Serious illness care planning occurs once a patient with advanced illness reaches a life expectancy of one to two years. Patients face a wide range of choices that can profoundly affect their quality of life. Planning for the last months and days may improve quality of life, by assuring health care supports patient goals and that preferences for life-sustaining interventions honored. For many patients, this planning should occur in the primary care setting, but primary care practices are over-extended, clinicians and staff are often uncomfortable discussing prognosis, and patients and families often do not ask.

The Serious Illness Care Program (SICP) provides a comprehensive implementation strategy, training modules, and a structured conversation guide to promote realistic and compassionate discussions with seriously ill patients in any health care setting. SICP is widely used, having trained hundreds of clinicians and used with thousands of patients. It contributes to the quadruple aims of optimizing healthcare performance through improving patient experience and appropriate utilization of resources, increasing population health, and improving the work life of clinicians. The challenge is that it is unclear whether whether targeting clinicians or entire teams is more efficient and effective when implementing SICP in primary care.

Study Aims:

The study will fill this critical gap by comparing two models of SICP in primary care: clinician-focused SICP and team-based SICP. In the clinician-focused model, a patient's primary care clinician is responsible for serious illness care planning, while in the team-based model, tasks are purposefully shared across roles. This cluster-randomized trial has the following aims:

* AIM 1. Assess the comparative effectiveness in primary care of team-based vs. primary clinician-focused SICP to achieve the long-term outcomes of concordance of care with patient goals and more time at home for patients with prognoses of two years of life or less.
* AIM 2. Assess the comparative effectiveness in primary care of a team-based SICP vs. clinician-focused SICP on place of death and family bereavement in cases where the patient dies during the study period, as well as additional secondary short term and intermediate outcomes including patient, family and clinician satisfaction with communication and decisions and quality of life.
* AIM 3. Identify determinants of successful implementation of the two different models of SICP across varying settings, with a focus on the comparison of practices in the U.S. and Canada and on practice-level characteristics.

Overall study design A cluster-randomized controlled trial (cRCT) conducted in primary care practices recruited from seven practice-based research networks (PBRNs) in the U.S. and Canada. The practices will be randomly assigned to implement either the primary care clinician-focused model or the team-based model. A cRCT is proposed because the two models cannot be implemented simultaneously in the same practice. SICP requires changes in work flow and different training is required for the clinician-focused and team-based models.

Main components of the intervention and comparators The clinician-focused model provides training and standard infrastructure support within the practice, similar to what would be provided for any primary care clinician activity. The team-based model splits the serious illness care conversation and planning into its components and these are shared across team members and may be spread over time. The composition of the teams and how they divide their tasks will be allowed to vary across practices and patients; this is necessary and realistic as staffing patterns and resources vary across practices and ACP should be customized to patient needs.

Study population The target population is adults living in the community with serious illnesses and their families. The study will be conducted in a minimum of 36 primary care practices in seven primary care PBRNs (five in the U.S., two in Canada). Each PBRN will recruit a minimum of six practices to enroll 130 patients for a total of 1260 enrolled, so that with attrition, over 750 will be available for analysis.

Primary and secondary outcomes The primary outcomes are patient-centered. These are: a) care that corresponds to patient goals and b) time spent at home. Assuring goal-concordant care is the overarching purpose of the SICP. Patient outcomes will be measured at enrollment, six months, and one year of follow-up. If the patient dies during the study period, place of death will be recorded and a family member contacted to complete a bereavement survey.

Secondary outcomes will also include intermediate and proximal or short-term outcomes for patients and families including patient and caregiver quality of life, depression and anxiety, satisfaction with communication, decision quality, engagement and acceptability of the SICP program and model to patients.

Analytic methods Analytic models will be refined with the input of the Research Project Partnership (Steering Committee), including patient and clinician stakeholder representatives as well as experts in biostatistics. Analysis will be conducted under an intention to treat assumption with multiple imputation procedures and selection models for missing data. Multilevel modeling will be used to account for clustering at the practice (cluster) and individual level, and interaction terms will be included in the analysis to identify potential heterogeneity of treatment effects.

Team-based Versus Primary Care Clinician-led Advance Care Planning in Practice-based Research Networks

A Cluster-randomized Trial Comparing Team-based Versus Primary Care Clinician-led Advance Care Planning in the Meta-LARC Practice-based Research Networks

The study protocol has been published after ClinicalTrials.gov registration and IRB approval and is now listed in the citations. Data will released in accordance with the funder's policy (PCORI) after the end of the project.

Results tables will be submitted to ClinicalTrials.gov

Comparison between arms of whether care received corresponds to patient goals. This will be assessed at 12 months.

Days at home will be reported over a 6-month range and will be compared between arms. Patients will report number of days spent in a hospital, nursing home or post-acute care home and number of trips to the emergency department during the last 6-month period. The number of days and ED trips reported will be combined then subtracted from the number of days in the 6-month reporting period to arrive a final number of days at home. This measure will be compared between both study arms.

Participant assessment of anxiety using the Generalized Anxiety Disorder 7-item scale (GAD7) using 4-point scale for seven anxiety questions where low scores indicate less anxiety and high scores are higher levels of anxiety symptoms and a single composite score is calculated.

Participant assessment of depression using the Patient Health Questionnaire depression test questionnaire (PHQ-9) scale using 4-point scale for nine depression questions where low scores indicate less depressive and high scores are higher levels of depressive symptoms and a single composite score is calculated.

Participant assessment of health, quality of life, mental health, satisfaction with social activities and roles, daily activities of living, anxiety/depression, sleep and pain using the PROMIS Global Health 10 short form

Participant assessment of the SICP conversation and program using and adapted SICP-developed Patient Acceptability Survey

Participant assessment of the SICP conversation and program using and adapted SICP-developed Patient Experience Survey

Participant rating of the communication with the clinician or care team using a subset of questions from the Quality of Community questionnaire which uses an 11-point scale on 13 questions to rate care from the worst I could imagine (low score) to the very best I could imagine (high score), with a summed total score

Measurement of shared decision-making using questionnaires to measure different aspects of making healthcare decisions, such as engagement, sureness, difficulty making a decision, and level of distress or remorse after making a decision. Each of these shared decision-making subscales will be scored

Participant report of use of hospice or palliative care services

Patient reports on confidence in future care, trust in providers and family, and advance care planning processes responding to 10-point scale or yes/no questions.

Comparison between arms of whether care received corresponds to patient goals. This will be assessed at 6 months.

University of Wisconsin, Madison

University of Colorado, Denver

University of Iowa

Duke University

Laval University

University of Toronto

Oregon Health and Science University

Associate Professor

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Prostatic Neoplasms

Lung Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Treatment as usual. Mainly based on standard physical rehabilitation.

Based on the results of the CGA, a tailored multidisciplinary intervention will be proposed, focused on a multicomponent physical exercise program with nutritional recommendations.

1) Multi-component exercise intervention program based on Vivifrail©. It consists of 1 daily-30 minutes session, twice a week, for 10 consecutive weeks supervised by an experienced exercise specialist. Exercises (resistance, gait retraining, balance training) are personalized depending on the person's functional capacity (evaluated by the SPPB and a walking speed test) and the risk of falling. Between sessions, individual, unsupervised training by the own patient, supported in the case by the caregiver, will be stimulated, through the recommendations of ViviFrail©. 2) Nutrition. Personalized recommendations according to nutritional and medical status (active oncologic treatment, remission, or palliative stage) will be offered according to the ESPEN recommendations for cancer patients, aimed at compensating for inadequate energy intake, improving patients' malnutrition risk stage (assessed by means of the MNA-SF).

Intervention group

General recommendations (written and videos) will be offered.

Control group

The PROFIT study has two complementary aims. The first aim is to compare, in a cohort study enrolling N=257 older adults (\>65 years) with lung, gastrointestinal and prostate cancer, different easy measures of frailty (Geriatric 8 questionnaire (G8), Short physical Performance Battery (SPPB) and the IF-VIG), testing their ability to predict survival, functional status (ECOG, Barthel Index), quality of life (EuroQol5D) and resources utilization (visits, hospital admissions, treatments) at 3, 6 and 12 months. The second aim, which motivates the registration in ClinicalTrials.gov, is to conduct a randomized controlled trial (RCT) enrolling N=134 patients per group, with similar characteristics to those enrolled for aim 1, but with mild-moderate frailty (G8≤14 points); we will compare a multi-component CGA-based intervention including physical exercise and nutritional recommendations with usual care, measuring the impact on the same outcomes as for aim 1, at 3 and 6 months. The use of ad hoc eHealth solutions (App/platform for exercise) will foster patients' empowerment and sustainability of the intervention. We will also assess patients, caregivers, and professionals' experience with the intervention through focus groups. Participants will be recruited from outpatients and from post-acute care units.

The impact of the aging of population on cancer incidence and consequences is clear: in very few years, more than 50% of older adults will be diagnosed with malignant tumors, with a relevant increase in mortality compared to younger adults, and a dramatic burden of disability. Many of these patients will be potential candidates for oncospecific treatments, either curative, adjuvants or palliative. Despite this scenario, many trials on cancers still exclude patients based on their age or set survival and treatments' toxicity as the main outcomes, neglecting other meaningful outcomes such as functional status or quality of life. Therefore, clinical decisions regarding this specific population are not always based on real-life data. Moreover, older adults are a highly heterogeneous population, based on clinical, functional, and psychosocial aspects. This is why, in such a population group, the individualization of treatments is pivotal.

Frailty has been proposed as a better marker of biological age than chronological age. This concept indicates a reversible state of risk of increased vulnerability to external or internal stressors, exposing the patients to a higher risk of adverse events, including disability and mortality. However, there is no agreement on the most suitable frailty tools to be used in practice. In older adults with cancer, frailty, which is easily measured in any setting through quick clinical scales, could be an ideal trigger to select candidate patients for a subsequent more extensive comprehensive geriatric assessment (onwards, CGA) and potential interventions. Among these interventions, multi-component approaches including physical exercise and nutritional recommendations have shown a positive impact on both mortality and functional status in patients with different cancers and could be proposed for either pre-habilitation or re-habilitation in older cancer patients with mild-moderate frailty.

Considering these premises, the PROFIT study has two complementary aims. The first aim is to compare, in a cohort study enrolling N=257 older adults (\>65 years) with lung, gastrointestinal and prostate cancer, different easy measures of frailty (Geriatric 8 questionnaire (G8), Short physical Performance Battery (SPPB) and the IF-VIG), testing their ability to predict survival, functional status (ECOG, Barthel Index), quality of life (EuroQol5D) and resources utilization (visits, hospital admissions, treatments) at 3, 6 and 12 months. The second aim is to conduct a randomized controlled trial (RCT) enrolling N=134 patients per group, with similar characteristics to those enrolled for aim 1, but with mild-moderate frailty (G8≤14 points); we will compare a multi-component CGA-based intervention including physical exercise and nutritional recommendations with usual care, measuring the impact on the same outcomes as for aim 1, at 3 and 6 months. The use of ad hoc eHealth solutions (App/platform for exercise) will foster patients' empowerment and sustainability of the intervention. We will also assess patients, caregivers, and professionals' experience with the intervention through focus groups. Participants will be recruited from outpatients and from post-acute care units.

The PROFIT study will add relevant evidence for the management of older cancer patients. The impact, for the individual and the society, is high, in light of the aging of the population: the results will allow providing oncologists and other professionals with tools to improve the personalization of treatments, to finally provide adequate and tailored care programs. This might contribute to avoid the exclusion of patients who could benefit from active treatments and, on the other hand, reducing overtreatment for those who will likely not benefit from it. The clinical trial will also provide information on the most suitable content and on the impact of an intervention aimed at strengthening the functional status and improving the quality of life in older cancer patients with mild-moderate frailty, who might be potential candidates for subsequent onco-specific treatments. The project will also deliver adapted materials and eHealth solutions to be potentially scaled up for this profile of users, as a benefit for the society even beyond this project.

PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)

Change in physical function, measured by the difference on SPPB between follow-ups, hand grip and maximum resistance.

Intensity of specific symptoms related to cancer

Potential adverse effects of the intervention

Collecting ocurrence of angina, myocardial infarction, TIA and/or stroke

Related to process \& resources utilization

Servicio de Geriatría Complejo Hospitalario de Navarra (CHN)

Fundación Miguel Servet - Navarrabiomed

Hospital de la Ribera, Alzira, Valencia

Institut Català d'Oncologia ICO Girona

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Servei Andorrà d'Atenció Sanitària (SAAS), Andorra

Gemelli Hospital, Universidad Cattolica del Sacro Cuore, Roma (Italia)

Hospital Universitari Vall d'Hebron Research Institute

Colonic Neoplasms

Frailty

Colorectal Neoplasms

Colonic Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

A comprehensive geriatric assessment and intervention, including exercise program.

A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.

Geriatric intervention

Julia S Johansen, MD, PhD

The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.

The main aim of the study us to see if the functional decline in this group can be reduced.

This is a randomized, controlled trial on frail older patients (aged 65 years or older) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.

Physiotherapist assessing function status.

Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer

functional test measuring lower body strength

EORTC European Organisation for Research and Treatment of Cancer questionnaire C30 (30-126 points where 30 is the worst)

EORTC European Organisation for Research and Treatment of Cancer questionnaire conjoined with ELD14 (Elderly Cancer Patient module) (14-54 points where 54 is the worst)

Measured with the questionnaire: Quality of Recovery - 15 questionnaire (0-150 points where 0 points is the worst)

measured by dual-energy x-ray absorptiometry

the concentration of CRP (CRP C-reactive Protein)

the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)

the concentration of 92 proteins associated with immuno-oncology (OLink)

the concentration of GDF-11 (GDF Growth Differentiation Factor)

the concentration of GDF-15 (GDF Growth Differentiation Factor)

Measured with Clavien Dindo classification (grade I-V where grade V is death)

Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.

according to guidelines, if physical condition allows it (and patient accepts it).

Velux Fonden

University of Copenhagen

Herlev and Gentofte Hospital

MD, Principal Investigator, Department of internal Medicine

Nutritional and Metabolic Diseases

Sarcopenia

Esophageal Neoplasms

Malnutrition

Thoracic Neoplasms

Aortic Dissection

Dissection, Blood Vessel

Aneurysm

Acute Aortic Syndrome

Aortic Diseases

Nutrition Disorders

Atrophy

Muscular Atrophy

Neuromuscular Manifestations

Neurologic Manifestations

Pathological Conditions, Anatomical

Esophageal Cancer

Acute Graft Versus Host Disease

Frailty model for patients undergoing esophagectomy and pneumonectomy/lobectomy for cancer

1. Grip strength
2. 30 second chair sit stand test
3. Psoas muscle area
4. Six minute walk

Frailty model

Sudish Murthy, MD, PhD

The purpose of this study is to develop an all-encompassing frailty model using laboratory and functional studies. A frailty model will help us determine prior to surgery who will require rehabilitation and skilled nursing needs beyond discharge. This model will also help us determine who will likely be readmitted and why they will be readmitted. Understanding these things can help us prevent some of them from occurring in the future.

Frailty is a widely accepted but poorly defined physical condition that has been shown to be an independent predictor of surgical morbidity and direct discharge to skilled nursing facility (SNF). Attempts have been made to study frailty in surgical patients by employing models designed for the general population. Despite the attempts of studying frailty in general surgery patients, no study has designed a model comprised of objective metrics for general thoracic surgery patients.

The purpose of this study is to better understand frailty in the context of thoracic surgery patients and to develop an objective model of this nebulous variable. It is hoped that standard, simple, functional and laboratory data can be used to construct the model with the goal being to determine the impact of frailty on outcome for patients undergoing esophagectomy, lobectomy, or pneumonectomy. If a preoperative frailty index can be developed and demonstrated to predict outcome, this scoring system may allow care teams to predict post-operative complications, ICU and hospital recidivism, and early mortality, and possibly allow for much earlier preparation for unfavorable outcomes.

A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery

Number of STS defined complications (chest tube airleak, atelectasis, pleural effusion requiring drain, pneumonia, ARDS, respiratory failure, bronchopleural fistula, PE, pneumothorax, chylothorax, ventilator \> 48 hours, tracheostomy, tracheobronchial injury, ileus, anastomotic leak, GI dilation, conduit necrosis requiring surgery, delayed conduit emptying, C. diff, delirium) will be combined to report the number of morbidity events

Time spent in the hospital during perioperative stay

If a patient requires a readmission to the hospital within 30 days of discharge and the reasons for readmission

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Team-based Versus Primary Care Clinician-led Advance Care Planning in Practice-based Research Networks	NCT03577002	Congestive Hear... Cancer Chronic Obstruc... Cerebrovascular... Frail Elderly S... Cardiovascular ...	Serious Illness...	18 Years -	Oregon Health and Science University
PeRsonalizing the Approach to the Oncologic Frail Individual Through Tailored Assessment and Intervention (PROFIT Study)	NCT05319145	Older Adults Gastro-Intestin... Prostate Cancer Lung Cancer Frail Elderly S...	Intervention gr... Control group	65 Years -	Hospital Universitari Vall d'Hebron Research Institute
Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer	NCT03719573	Colon Cancer Colon Neoplasm Frail Elderly S... Colorectal Canc...	Geriatric inter...	65 Years -	Herlev and Gentofte Hospital
A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery	NCT03413449	Thoracic Thoracic Neopla... Lung Cancer Esophageal Canc... Surgery--Compli... Surgery Sarcopenia Malnutrition Frail Elderly S...	Frailty model	18 Years -	The Cleveland Clinic
A Prospective Study Frailty for Esophagectomy and Lung Resection in Thoracic Surgery	NCT03413449	Thoracic Thoracic Neopla... Lung Cancer Esophageal Canc... Surgery--Compli... Surgery Sarcopenia Malnutrition Frail Elderly S...	Frailty model	18 Years -	The Cleveland Clinic

Spots Global Cancer Trial Database for frail elderly syndrome