PHASE I: Registered Nurses receive training on how to administer the G8 screening tool utilizing an Epic flowsheet to patients using a self-directed education module and by direct assessment by a geriatrician.

PHASE II: Patients complete the G8 screening tool questionnaire over 10 minutes as part of their standard initial assessment, and their answers are entered into their EHR flowsheet. Patients who score =\< 14 on the G8 are referred for a CGA at SAOC, and these patients and their medical oncologists are made aware. Within 2 weeks of the initial screening, the results are communicated with the patient and medical oncologist at a 2-hour SAOC visit. Patients with a score of \> 15 on the G8 are made aware of their results without any referral generated.

Receive G8 screening tool administration training

Educational Intervention

Screening Questionnaire Administration

Referral

Questionnaire Administration

This phase II trial investigates how easy it is to incorporate a nursing led geriatric assessment screening tool into a busy oncology practice, in order to identify at-risk older adults being evaluated for cancer treatment. This screening tool may help identify at-risk patients who can be referred for more in depth assessment, allowing for the creation of an individualized treatment plan that puts the patient's safety and personal goals as a priority.

PRIMARY OBJECTIVE:

I. To determine the feasibility of training nurses to administer the Geriatric 8 (G8) screening tool in an oncology practice, to identify older patients (\> 65 years old \[y/o\]) that would benefit from a more extensive Comprehensive Geriatric Assessment (CGA).

SECONDARY OBJECTIVE:

I. To report the positive predictive value of the G8 screening tool with the final frailty designation determined by the Comprehensive Geriatric Assessment completed in patients referred to the Senior Adult Oncology Center (SAOC).

OUTLINE:

PHASE I:

Registered Nurses receive training on how to administer the G8 screening tool utilizing an Epic flowsheet to patients using a self-directed education module and by direct assessment by a geriatrician.

PHASE II:

Patients complete the G8 screening tool questionnaire over 10 minutes as part of their standard initial assessment, and their answers are entered into their electronic health record (EHR) flowsheet. Patients who score =\< 14 on the G8 are referred for a CGA at SAOC, and these patients and their medical oncologists are made aware. Within 2 weeks of the initial screening, the results are communicated with the patient and medical oncologist at a 2-hour SAOC visit. Patients with a score of \> 15 on the G8 are made aware of their results without any referral generated.

Geriatric Assessment Screening Tool for the Identification of At-Risk Older Adults Who Are Undergoing Cancer Treatment

Feasibility of Implementation and Assessment of Geriatric Assessment Screening Tool in Outpatient Oncology Clinic

The score will be a number between 1-20. The responses to two questions of primary interest, assessing their comfort caring for older adults and their comfort in administering the G8 tool, will be binary measurements. The overall assessment scores from pre- and post- self-administered learning module will be compared using paired Wilcoxon test.

Will be summarized by sample means, standard deviations and/or percentages.

The percentage of patients being determined as vulnerable/frail by Comprehensive Geriatric Assessment (CGA) at SAOC, i.e. the predictive positive value of G8, will be reported with its 95% confidence interval. The summary statistics of additional collected SAOC metrics including the Timed Up and Go test, prior history of falls, cognitive screen, depression screen, mortality prognostication, expected life expectancy, social distress thermometer, Mini Nutritional Assessment (MNA), presence of polypharmacy and inappropriate medications, and Eastern Cooperative Oncology Group (ECOG) score will be reported by means, standard deviations and percentages.

Thomas Jefferson University

standardized referral to outpatient palliative care by oncologists

Implementation of a system to help oncologists to identify criteria for referring patients to specialized outpatient palliative care (Palliative Care Referral System - PCRS)

Palliative Care Referral System - PCRS

Augusto T Caraceni, MD

Alessandra Pigni, MD

Early palliative care (EPC) in the clinical pathway of advanced cancer patients improves symptom control, quality of life and has a positive impact on overall quality of care. EPC contributes to realistic and attainable goals of treatment, facilitating patient choices, favouring adequate communication with patients and families and assessing patient values and preferences with regard to advance care planning. EPC is likely to promote a more appropriate use of health care resources and less aggressive cancer treatment in the last weeks of life. At present standardised criteria for appropriate referral for EPC in oncology outpatients setting are lacking. Therefore the aim of this project is to identify referral criteria and procedures to implement appropriate EPC for advanced patients (the Palliative Care Referral System) and test them in a pre-post experimental design evaluating their impact on quality of care and on the use of healthcare resources. A quasi-experimental, longitudinal, pretest-posttest study will be carried out. Two different cohorts of 150 advanced cancer patients each will be enrolled before (pretest) and after (posttest) the introduction of the PCRS in outpatient clinics of a Comprehensive Cancer Centre. Eligible patients will undergo patient-reported outcome measure (PROMs) evaluation at baseline and then monthly for at least 6 months from enrollment or till death. Use health care resources and quality of care indicators will be collected monthly by a dedicated research nurse.

A quasi-experimental, longitudinal, pretest-posttest study will be carried out. Two different cohorts of 150 advanced cancer patients each will be enrolled before (pretest) and after (posttest) the introduction of the PCRS in outpatient clinics.

Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease

Implementation of a Standardized Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease: Impact on Patient and Caregiver Satisfaction With Care and Use of Health Care Resources.

patient satisfaction with care, measured with the FAMCARE-P13

European Organisation for Research and Treatment of Cancer - Quality of Life -Palliative Care questionnaire (Eortc QLQC15-PAL)

Number of regular outpatient Palliative Care visits

Number of multidisciplinary team visits (Oncology and Palliative Care)

Number of accesses in Emergency departement

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

director of Palliative Care Unit

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Leukemia

Pain

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Chronic Graft Versus Host Disease

Lymphosarcoma

ASCENT study interventionists complete an interview on study.

Medical oncology providers participate in a focus group on study.

Acupuncture Therapy

Cancer Pain Management

Cognitive Behavior Therapy

Discussion

Receive self-guided pain management education materials

Exercise

Interview

Massage Therapy

Mindfulness Relaxation

Pain Therapy

Palliative Therapy

Undergo visits with PCM and CHW for pain management

Patient Navigation

Spiritual Therapy

Spiritual Care Referral

Survey Administration

Clinical Trials Referral Office

Donald W. Northfelt, M.D.

Andrea L. Cheville, M.D.

This clinical trial tests how well a pain management intervention preparatory to a future pragmatic trial works in rural dwelling and Hispanic cancer survivors. Cancer pain is a key case study in health disparities in the United States. Cancer pain is prevalent, under treated, and remains a major cause of suffering, impairment, and disability for millions of Americans. Individual pain interventions and care models show promise for cancer pain in controlled settings. Hispanic and rural-dwelling cancer survivors stand to benefit the most from electronic health record innovations, as each of these health disparities populations experience profound disparities in pain outcomes, including marked under- and over-prescribing of opioids. Additionally, Hispanics not only comprise a steadily growing proportion of cancer survivors, but are also increasingly immigrating to rural communities, potentially placing them at "double risk" for poor outcomes. This trial will allow for the refinement of pain management intervention components that could help the management of cancer-related pain in rural dwelling and Hispanic cancer survivors.

PRIMARY OBJECTIVE:

I. To refine and pilot test components of a validated collaborative care model-based intervention aimed at improving pain control among rural dwelling and Hispanic cancer survivors.

OUTLINE: Participants are assigned to 1 of 3 groups.

GROUP I: Participants meet with pain care manager (PCM) and community health worker (CHW) via telephone or video visit to discuss the cancer-related pain. Participants receive self-guided pain management education materials and receive an action plan with suggestions or referrals to participate in tier 1 interventions that include exercise, cognitive behavioral therapy, medication and/or tier 2 interventions that include integrative medicine (massage, acupuncture and mindfulness relaxation), spiritual support, pain clinic referral and palliative and spiritual care referrals during the intake visit. Participants undergo a planning visit 2 weeks later to give an update on their pain and may receive additional resources from the PCM and/or CHW. Participants then undergo a final visit 4 weeks later with the PCM and/or CHW and receive final recommendations and referrals. Participants may receive a follow up call between intake and visit 2 and/or between visit 2 and the final visit from the CHW or PCM to assess pain levels on study.

GROUP II: ASCENT study interventionists complete an interview on study.

GROUP III: Medical oncology providers participate in a focus group on study.

Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study

Pilot Test of a Pain Management Intervention Preparatory to a Future Pragmatic Trial (ASCENT)

Assessed by the proportion of patients calling the ASCENT 1-800 line to express interest

Assessed by the proportion of participants who open and completed the PCIG Questionnaire, a 0-6 scale where 0 is very much improved and 6 is very much worse

Assessed by the proportion of participants who open and completed the EQ-5D-3L questionnaire. Page 1 of the EQ-5D-3L descriptive system is comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. Responses are expressed in a 5-digit number that describes the patient's health state.Page 2 is a vertical visual analog (sliding) scale (VAS) with the opposite endpoints labeled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.

Assessed by the proportion of participants who open and completed the PCS Questionnaire, which consists of 13 statements containing a number of thoughts and feelings one may experience when having pain. The items are divided into the categories of rumination, magnification and helplessness, with each item scored on a 5-point scale where 0=Not at all; 1=to a Slight Degree; 2=To a Moderate Degree; 3=To a Great Deal; and 4=All the Time.

Assessed by the proportion of participants who open and completed the PHQ-8, a depression measure which consists of 8 questions, with each item scored on a 4-point scale: Not at all; Several days; More than half the days; Nearly every day.

Assessed by the proportion of participants who open and completed the GAD-7, an anxiety measure which consists of 7 questions, with each item scored on a 4-point scale: Not at all; Several days; More than half the days; Nearly every day.

Assessed by the proportion of participants who open and completed the PSEQ, a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. Each item is scored on a 0-6 scale where 0=Not at all confident and 6=Completely.

Assessed by the proportion of participants who provide complete Social Determinants of Health (SDOH) histories by answering a series of 6 questions related to homelessness, safety in the home, health, and mood.

Assessed by the proportion of participants who complete the Pain NRS, a 0-10 scale where 0 is no pain and 10 is the worst pain imaginable

Assessed by the proportion of participants who complete the IT Assessment, which consists of 4 questions related to technology access and usage.

Assessed by the proportion of participants who complete the TAPS-1 Questionnaire, the tool's first-stage screening component, which consists of five questions related to usage of four substance categories (tobacco, alcohol, prescriptions, or other substances) in the past 12 months. Response option are 0-Daily or Almost Daily, 1-Weekly, 2-Monthly, 3-Less Than Monthly, or 4-Never.

Assessed by the proportion of participants who select a Tier 1 pain management intervention or request review of Tier 2 pain management options

Assessed on an 11-point numerical rating scales (NRS) by Pain Care Managers and/or Community Health Workers who are conducting intake interviews.

Assessed by the proportion of participants who request revisions to the recommended plan

Assessed by the proportion of participants who develop a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal

Assessed by the proportion of participants who complete a SMART (Specific, Measurable, Achievable, Relevant, and Time-Bound) Goal

Assessed by the category of pain intervention selected during the planning visit as the initial focus of a multi-modal pain care plan, either Tier 1 (Exercise, Cognitive Behavior Therapy \[CBT\], and Medicine) or Tier 2 (Integrative Medicine \[Massage, Acupuncture, Mindfulness\], Spiritual Support, Pain Clinic Referrals, and/or Palliative and Spiritual Care Referrals).

Recorded as the category/ies of barriers impeding receipt of recommended pain care, as assessed by a brief survey

Assessed by the proportion of participants completing surveys by administration mode (electronic health record portal, video visit, or phone interview, or printed questionnaire)

Assessed by the proportion of participants completing surveys by administration mode, cause of pain escalation (categorical), and participant-perceived barriers (categorical).

Assessed by participant-reported categories of barriers impeding receipt of recommended pain care

Overall participant response rates will be assessed according to the number of patient-reported outcome measure (PROM) assessments, recruitment questionnaires, and remote pain assessments completed.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Geriatric Assessment Screening Tool for the Identification of At-Risk Older Adults Who Are Undergoing Cancer Treatment	NCT04788758	Hematopoietic a... Malignant Solid...	Educational Int... Screening Quest... Referral Questionnaire A...	-	Thomas Jefferson University
Geriatric Assessment Screening Tool for the Identification of At-Risk Older Adults Who Are Undergoing Cancer Treatment	NCT04788758	Hematopoietic a... Malignant Solid...	Educational Int... Screening Quest... Referral Questionnaire A...	-	Thomas Jefferson University
Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease	NCT04936568	Advanced Cancer	Palliative Care...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Palliative Care Referral System (PCRS) for Cancer Patients With Advanced Disease	NCT04936568	Advanced Cancer	Palliative Care...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study	NCT06063603	Chronic Leukemi... Hematopoietic a... Lymphoma Malignant Solid... Multiple Myelom...	Acupuncture The... Cancer Pain Man... Cognitive Behav... Discussion Educational Int... Exercise Interview Massage Therapy Mindfulness Rel... Pain Therapy Palliative Ther... Patient Navigat... Referral Spiritual Thera... Spiritual Care ... Survey Administ...	18 Years -	Mayo Clinic
Evaluation of a Pain Management Intervention Preparatory to a Future Pragmatic Trial, ASCENT Study	NCT06063603	Chronic Leukemi... Hematopoietic a... Lymphoma Malignant Solid... Multiple Myelom...	Acupuncture The... Cancer Pain Man... Cognitive Behav... Discussion Educational Int... Exercise Interview Massage Therapy Mindfulness Rel... Pain Therapy Palliative Ther... Patient Navigat... Referral Spiritual Thera... Spiritual Care ... Survey Administ...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for referral

Every month we try and update this database with for referral cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for referral

Every month we try and update this database with for referral cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for referral cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.