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Mobile Health Application and Wearable Device
Mobile Health Technology for Colorectal Cancer Recovery
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Readmission rate
Secondary outcome measures
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%
Pancreatic carcinoma
1%
Shunt thrombosis
1%
Angina pectoris
1%
Myocardial infarction
1%
Pericarditis
1%
Jaundice
1%
Shunt occlusion
1%
Gastroenteritis
1%
Hernia
1%
Chest discomfort
1%
Arteriovenous fistula thrombosis
1%
Skin ulcer
1%
Fluid retention
1%
Hypovolaemia
1%
Hypertensive crisis
1%
Cognitive disorder
1%
Joint dislocation
1%
Joint injury
1%
Blood potassium increased
1%
Catheter placement
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
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
1,054 Previous Clinical Trials
1,316,212 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: Standard of care
- Group 2: Mobile app and Fitbit + 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current number of research participants in this experiment?
"Affirmative. Clinicaltrials.gov reveals that recruitment is underway for this medical experiment, which was originally listed on May 31st 2017 and refreshed most recently on July 29th 2022. The clinical trial requires 316 participants to be gathered at 1 location."
Answered by AI
Are there still positions available for individuals interested in participating in this clinical trial?
"Affirmative. Data hosted on clinicaltrials.gov confirms this trial is currently recruiting individuals, having been first posted on May 31st 2017 and recently updated July 29th 2022. The study requires 316 participants from a single site to participate."
Answered by AI
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