Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

This is the intervention group and will consist of patients that have been randomized into the early palliative group, with a consultation expected to take place within one week of randomization. Patients in this group will still receive appropriate guideline based oncologic care including any surgical, brachytherapy, chemotherapy or radiotherapy services, along with palliative services.

Metastatic esophageal cancer patients that receive early palliative care along with standard oncological care

Early Palliative Care

Christian Finley, MD MPH FRCSC

Palliative care physicians and nurses are trained to help reduce suffering and improve quality of life in patients under their care. Their services also include other components such as referral to dietitians, social workers and community resources, to assist patients in their homes. In addition to this, they may also administer interventions to make patients more comfortable, assisting them and their families in making important decisions and providing support, during that time.

At present, palliative care is provided to esophageal cancer patients on an as-needed basis, through the referral of a heath care professional or the patient's request. This study aims to assess the impact of the integration of early palliative care combined with appropriate medical care in the metastatic esophageal cancer population, so that patients can benefit from these services at an earlier stage. It is hoped that this will improve quality of life, symptom management, depression and anxiety, as well as survival.

Previous reports suggest that starting palliative care early in patients with breast, colorectal, prostate and lung cancers appear to improve quality of life, symptom management, depression, anxiety and perhaps even survival, but it has never been tested in patients with esophageal cancer.This study aims to assess the impact of the introduction of early palliative care services on the esophageal cancer population, as opposed to traditional palliative care, which is provided on an as-needed basis, usually in end-of-life situations.

The study is a prospective one-armed pre-post intervention evaluation. Eligible patients that have consented will receive an early consultation with the palliative care group. In addition to this, the patients will be administered appropriate oncological care including surgical, brachytherapy, chemotherapy or radiotherapy services. The patients will be referred to the palliative service at the time of consent, with a consultation taking place within one week of referral receipt. The nurses and physicians involved in the palliative service will not only provide symptom management, psychosocial support, assistance with treatment related decisions and other patient needs. Information about symptoms, anxiety and depression, and quality of life will be collected through surveys at two timepoints - at baseline, when the patient consents and at 12 weeks post diagnosis of metastatic disease. The primary outcome of the study is the change in quality of life perceived by esophageal cancer patients at the two timepoints. Secondary outcomes include differences in esophageal cancer specific symptoms and anxiety and depression scores at the two timepoints, as well as patient survival information.

This study is integrated into the currently operational Esophageal Diagnostic Assessment Program (EDAP) conceptualized and implemented at St. Joseph's Healthcare Hamilton. It is hoped that this study will also help to establish the full integration of palliative care into the overall care of patients with esophageal cancer.

Early Integration of Palliative Care in Esophageal Cancer Patients

Evaluation of the Implementation of an Early Integrated Palliative Care Program in the Esophageal Cancer Population

Change in perceived quality of life as reported by esophageal cancer patients.

Reported using the Functional Assessment of Cancer Therapy-Esophagus (FACT-E) tool - includes physical well-being, social/family well-being, emotional well-being, functional well-being, and symptom-specific measures. Scores range from 0 (not at all) to 4 (very much), and assesses how severely the symptom affects patients.

The Patient Health Questionnaire (PHQ-9) will be used to measure the impact of the intervention on patient symptom management

Anxiety scores reported on the Hospital Anxiety and Depression Scale (HADS) Scale. The scores are summed to obtain a "normal", "borderline abnormal" or "abnormal" score

Depression scores reported on the Hospital Anxiety and Depression Scale (HADS) Scale. The scores are summed to obtain a "normal", "borderline abnormal" or "abnormal" score

Patient survival post metastatic esophageal cancer diagnosis

St. Joseph's Healthcare Hamilton

McMaster University

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

12 months of PC with concurrent standard treatment for MM, QOL assessments

Early PC Integration - Participants will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Participants will be scheduled to meet with a PC provider at least once per month. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers. All participants will receive routine oncologic care throughout the study period.

Palliative Care

FACT-MM questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.

FACT-MM questionnaire

HADS questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.

HADS questionnaire

Renato Samala, MD

Multiple Myeloma (MM) is a common type of cancer involving the cells in the blood (commonly affecting bones, kidneys and blood). Although it remains incurable, MM has become a highly treatable form cancer thanks to new and improved treatment modalities. As patients deal with this disease, they often suffer from multiple symptoms that are caused by both the disease itself and the different drugs used to treat it. Research has shown that the most common symptoms patients suffer from include pain, constipation, tiredness, tingling in hands and feet, breathlessness, sadness and difficulty remembering things. These symptoms may negatively affect the quality of life of patients.

Palliative care (PC) is a type of treatment aimed at relieving symptoms and promoting the most optimal quality of life (QOL) for patients and their caregivers. Research has shown that patients with certain types of cancers, such as colon cancer and lung cancer, do better if they are seen by a PC provider early in the course of their disease. This study seeks to determine the effects of early PC involvement on participants with newly diagnosed MM

This is a pilot study with a prospective cohort design, and based in the outpatient or ambulatory care setting. Each participant will be followed for 12 months.

Twenty eligible patients will be enrolled, and within eight weeks of diagnosis. Patients will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers and participants will receive routine oncologic care throughout the study period.

The primary objective of this study is to obtain preliminary data on the effects of early PC involvement in a cohort of patients with newly diagnosed symptomatic MM

The secondary objectives of this study are to assess self-reported QOL, estimate the change in QOL relative to baseline, estimate number of participants with self-reported symptoms of depression and anxiety, to determine if monthly PC visits are feasible for participants, and to estimate health services utilization.

Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma

A Pilot Study to Determine the Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma

Data from this pilot study will be used to design and power a larger prospective study.

Self-reported QOL as measured by FACT-MM scores

The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

Higher scores mean better QOL for all sections and total scores.

Self-reported QOL as measured by FACT-MM scores The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

Higher scores mean better QOL for all sections and total scores.

Change in QOL relative to baseline as measured by FACT-MM scores.

The questionnaire is a combination of the original widely used and validated FACT-G (Functional Assessment of Cancer Therapy-General) questionnaire (27 items), and 14 MM-specific items.

FACT-MM total scores range from 0 to 164, with FACT-G sections ranging from 0 to 108 and MM-specific section ranging from 0 to 56.

Higher scores mean better QOL for all sections and total scores.

Number of participants with self-reported symptoms of depression and anxiety as measured by HADS questionnaire. The questionnaire consists of 14 items, two subscales (depression and anxiety) of seven questions each for depression and anxiety. Each subsection has a possible score range of 0 to 21, with higher scores indicating worse outcomes. A score of greater than or equal to eight on either subscale is considered clinically significant (i.e., probable depression or anxiety).

Feasibility of monthly PC visits as measured by the number of PC visits made in the first 12 months after diagnosis

Health services utilization as measured by number of ER visits, hospital admissions or ICU admissions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Integration of Palliative Care in Esophageal Cancer Patients	NCT02547142	Esophageal Canc...	Early Palliativ...	-	McMaster University
Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma	NCT04248244	Multiple Myelom...	Palliative Care FACT-MM questio... HADS questionna...	18 Years -	Case Comprehensive Cancer Center
Effects of Early Palliative Care Integration on Patients With Newly Diagnosed Multiple Myeloma	NCT04248244	Multiple Myelom...	Palliative Care FACT-MM questio... HADS questionna...	18 Years -	Case Comprehensive Cancer Center

Spots Global Cancer Trial Database for hads questionnaire