Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477919
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2007-05-23
Brief Title:
E-MOSAIC Electronic Tool to Monitor Symptoms
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients weight KPS score body mass index and assessment of current medication for pain ie morphine-equivalent daily dose fatigue and anorexiacachexia syndromes weekly A Longitudinal Monitoring Sheet LoMoS is printed comprising VAS of pain pain medication fatigue KPS medication for fatigue ie 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
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 patients weight KPS score body mass index and assessment of current medication for pain ie morphine-equivalent daily dose fatigue and anorexiacachexia syndromes weekly A Longitudinal Monitoring Sheet LoMoS is printed comprising VAS of pain pain medication fatigue KPS medication for fatigue ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20711 | None | None | None |