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Mobile Health Application and Wearable Device
Mobile Health Technology for Colorectal Cancer Recovery
N/A
Waitlist Available
Led By Heather Yeo, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is scheduled to undergo surgery for a GI cancer (pancreatic, hepatic, gastric, small bowel, colon, or rectal cancers)
Subject speaks English
Must not have
Subject has sepsis from another source
Subject is undergoing emergent surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if mobile devices can help prevent readmission in patients who have had major GI cancer surgery.
Who is the study for?
This trial is for English-speaking adults over 18 who own a smartphone and are scheduled for GI cancer surgery (pancreatic, liver, stomach, small bowel, colon or rectal). It's not suitable for those with dementia, substance abuse issues, sepsis from another source or needing emergency surgery.
What is being tested?
The study compares the effectiveness of using mobile health apps and Fitbit alongside standard care versus standard care alone in preventing hospital readmission after major GI cancer surgeries.
What are the potential side effects?
Since this trial involves non-invasive tools like mobile apps and Fitbit devices along with usual medical care, side effects may be minimal but could include discomfort or skin irritation from wearing the device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery for a GI cancer.
Select...
I speak English.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently suffering from sepsis caused by another condition.
Select...
I am scheduled for urgent surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Readmission rate
Secondary study objectives
Healthcare utilization rates
Patient Satisfaction with Device
Quality of life: Return to Baseline Function-Activities of Daily Living (ADLs)
+1 moreSide effects data
From 2007 Phase 4 trial • 552 Patients • NCT001108907%
Diarrhoea
7%
Vomiting
3%
Nausea
3%
Nasopharyngitis
3%
Muscle spasms
1%
Angina pectoris
1%
Myocardial infarction
1%
Pericarditis
1%
Chest discomfort
1%
Hernia
1%
Jaundice
1%
Gastroenteritis
1%
Arteriovenous fistula thrombosis
1%
Joint dislocation
1%
Joint injury
1%
Shunt occlusion
1%
Shunt thrombosis
1%
Blood potassium increased
1%
Fluid retention
1%
Hypovolaemia
1%
Pancreatic carcinoma
1%
Cognitive disorder
1%
Skin ulcer
1%
Catheter placement
1%
Hypertensive crisis
1%
Arteriovenous fistula occlusion
1%
Orthostatic hypotension
1%
Cardiac arrest
1%
Chest pain
1%
Pyrexia
1%
Cholecystitis
1%
Arthritis bacterial
1%
Bacterial sepsis
1%
Fall
1%
Back pain
1%
Pain in extremity
1%
Dyspnoea
1%
Nephrectomy
1%
Hypotension
1%
Peripheral ischaemia
1%
Atrial flutter
1%
Cardiac asthma
1%
Abdominal pain
1%
Sudden cardiac death
1%
Transplant rejection
1%
Perianal abscess
1%
Pneumonia
1%
Urinary tract infection
1%
Ankle fracture
1%
Arteriovenous fistula site complication
1%
Rib fracture
1%
Cerebral infarction
1%
Gastrointestinal haemorrhage
1%
Catheter related infection
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Care
Cinacalcet
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of careExperimental Treatment1 Intervention
Participants will receive standard of care
Group II: Mobile app and Fitbit + Standard of careActive Control1 Intervention
Mobile health application and Fitbit + standard of care: Participants will utilize mobile app and Fitbit and standard of care. Mobility data will be generated using a mobile health tracker designed for smartphone devices.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,084 Previous Clinical Trials
1,147,205 Total Patients Enrolled
Damon Runyon Cancer Research FoundationOTHER
9 Previous Clinical Trials
1,038 Total Patients Enrolled
Heather Yeo, MDPrincipal InvestigatorWeill Medical College of Cornell University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor says I can't finish the study because of my dementia.I am currently suffering from sepsis caused by another condition.I am scheduled for surgery for a GI cancer.I speak English.I am 18 years old or older.I am scheduled for urgent surgery.Your doctor believes that you cannot participate in the study because you have a history of alcohol or drug abuse.You have a smartphone.
Research Study Groups:
This trial has the following groups:- Group 1: Mobile app and Fitbit + Standard of care
- Group 2: Standard of care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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