E-MOSAIC Electronic Tool to Monitor Symptoms

Study Overview
=================
Brief Summary
-----------------
RATIONALE: A hand held electronic tool used to monitor symptoms and assess quality of life may improve communication between patients and their doctors and improve the ability to plan treatment for patients with advanced cancer receiving palliative care. It is not yet known whether symptoms are better controlled with or without use of this electronic tool. PURPOSE: This randomized phase III trial is studying an electronic tool to see how well it records cancer symptoms in patients with advanced cancer receiving palliative care.

Detailed Description
-----------------
OBJECTIVES: Primary Determine the effect of an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC) and a Longitudinal Monitoring Sheet (LoMoS) on global quality of life (G-QOL) of patients with advanced incurable cancer receiving palliative anticancer treatment. Secondary Determine if this tool affects communication between these patients and their treating physicians. Determine if this tool affects the symptoms and syndromes reported by these patients. Determine if this tool impacts symptom management performance. Tertiary Identify factors influencing changes in G-QOL. Determine how patients adapt to illness and burden of treatment. Describe patients' decision-making preference. OUTLINE: This is a controlled, randomized, longitudinal, multicenter study. Physicians are stratified according to participating center. Physicians are randomized to 1 of 2 arms. All patients allocated to a physician undergo the same intervention. Arm I: Patients complete a weekly symptom assessment and nutritional intake using a Palm-based monitoring tool. Nurses record weight and Karnofsky performance status (KPS) scores weekly. A proof of electronic transfer sheet is printed and stored. Arm II: Patients complete a weekly assessment comprising visual analogue scales (VAS) of pain, fatigue, drowsiness, nausea, anxiety, depression, shortness of breath, loss of appetite, and overall well-being; up to 3 optional symptoms selected by the patient; and an estimated nutritional intake using an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC). Nurses record the patient's weight, KPS score, body mass index, and assessment of current medication for pain (i.e., morphine-equivalent daily dose), fatigue, and anorexia/cachexia syndromes weekly. A Longitudinal Monitoring Sheet (LoMoS) is printed (comprising VAS of pain, pain medication, fatigue, KPS, medication for fatigue [i.e., methylphenidate hydrochloride or epoetin alfa], anorexia, weight change, nutritional intake, medication, supplements, counseling for anorexia, VAS of individually selected symptoms) and stored. In both arms, patients are assessed for outcome criteria at baseline and at weeks 3 and 6 (end of study). PROJECTED ACCRUAL: A total of 24 physicians and 192 patients will be accrued for this study.

Official Title
-----------------
E-MOSAIC: A Multicenter Randomized Controlled Phase III Study of Longitudinal Electronic Monitoring of Symptoms and Syndromes Associated With Advanced Cancer in Patients Receiving Anticancer Treatment in Palliative Intention

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of advanced incurable cancer Symptomatic disease, defined as meeting ≥ 1 of the following criteria: Pain Visual Analogue Scale (VAS) ≥ 3/10 and/or morphine equivalent daily dose of ≥ 10 mg for ≥ 3 days Anorexia VAS ≥ 3/10 and/or weight loss of ≥ 2% in 2 months or ≥ 5% in 6 months Fatigue VAS ≥ 3/10 and/or Karnofsky performance status < 70% Depression or anxiety VAS ≥ 3/10 and/or treatment with antidepressants for ≥ 5 days and planned for ≥ 1 month Receiving continuously, weekly, or biweekly palliative anticancer treatment meeting 1 of the following criteria: At least 1 first-line treatment for any of the following: Metastatic melanoma Renal cell cancer Pancreatic cancer Biliary tract cancer Mesothelioma Prostate cancer (chemotherapy) Advanced glioblastoma At least 1 second-line treatment for any of the following: Extensive stage small cell lung cancer Stage IV non-small cell lung cancer Colorectal cancer Gastric cancer Esophageal cancer Bladder cancer Sarcoma Carcinoma of unknown primary At least 1 third-line chemotherapy regimen for any of the following: Metastatic breast cancer Ovarian cancer Anticancer treatment must be given in an outpatient setting, not within a clinical trial, with weekly monitoring, and expected tumor response rate ≤ 20% according to the literature No testicular cancer No hematological malignancies No primary brain tumors other than glioblastoma Physician characteristics: No change to standard of care for symptom assessment or to major communication skills strategies within the past 3 months Experienced in medical oncology (i.e., worked ≥ 50% in clinical oncology within the past 24 months) Likely to stay in the participating institution for the time required to treat ≥ 5 study patients Able to independently communicate with the patient about all aspects of cancer care Able to independently perform immediate changes of interventions in patient care without the institutional requirement to counsel another colleague before prescribing (i.e., for symptom control) Completed a basic communication skills course or equivalent training (i.e., familiar with communication skills) PATIENT CHARACTERISTICS: Able to understand assessment instrument language Able to understand physician communication without difficulty (i.e., due to culture, language, speech) PRIOR CONCURRENT THERAPY: See Disease Characteristics No concurrent participation in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Weekly assessment by E-MOSAIC<br>Patients complete a weekly assessment comprising visual analogue scales (VAS) of pain, fatigue, drowsiness, nausea, anxiety, depression, shortness of breath, loss of appetite, and overall well-being; up to 3 optional symptoms selected by the patient; and an estimated nutritional intake using an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC). Nurses record the patient's weight, KPS score, body mass index, and assessment of current medication for pain (i.e., morphine-equivalent daily dose), fatigue, and anorexia/cachexia syndromes weekly. A Longitudinal Monitoring Sheet (LoMoS) is printed (comprising VAS of pain, pain medication, fatigue, KPS, medication for fatigue [i.e., methylphenidate hydrochloride or epoetin alfa], anorexia, weight change, nutritional intake, medication, supplements, counseling for anorexia, VAS of individually selected symptoms) and stored. | |
| Palm-based monitoring tool<br>Patients complete a weekly symptom assessment and nutritional intake using a Palm-based monitoring tool. Nurses record weight and Karnofsky performance status (KPS) scores weekly. A proof of electronic transfer sheet is printed and stored. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC) and a Longitudinal Monitoring Sheet (LoMoS) on global quality of life (G-QOL) |  | Until trial ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if this tool affects communication between these patients and their treating physicians. |  | Until trial ends | 
| Determine if this tool affects the symptoms and syndromes reported by these patients |  | Until trial ends | 
| Determine if this tool impacts symptom management performance |  | Until trial ends | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fatigue, adult glioblastoma, stage IV melanoma, stage IV renal cell cancer, unresectable extrahepatic bile duct cancer, advanced malignant mesothelioma, stage IV prostate cancer, adult giant cell glioblastoma, adult gliosarcoma, extensive stage small cell lung cancer, stage IV non-small cell lung cancer, stage IV colon cancer, stage IV gastric cancer, stage IV esophageal cancer, stage IV bladder cancer, male breast cancer, stage IV breast cancer, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor, ovarian sarcoma, ovarian stromal cancer, anorexia, cachexia, pain, weight changes, depression, poor performance status, recurrent adult brain tumor, clear cell sarcoma of the kidney, advanced adult primary liver cancer, recurrent adult primary liver cancer, recurrent small cell lung cancer, recurrent bladder cancer, recurrent breast cancer, recurrent colon cancer, recurrent esophageal cancer, recurrent gastric cancer, recurrent melanoma, recurrent non-small cell lung cancer, recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage IV pancreatic cancer, recurrent prostate cancer, recurrent renal cell cancer, recurrent pancreatic cancer, stage IV rectal cancer, recurrent rectal cancer, recurrent malignant mesothelioma, recurrent carcinoma of unknown primary, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, recurrent extrahepatic bile duct cancer, unresectable gallbladder cancer, recurrent gallbladder cancer