Study Summary
This trial is testing a new system that sends patients information and tips about chemotherapy side effects and how to cope with them, in real time.
Eligible Conditions
- Esophageal Cancer
- Esophageal Squamous Cell Carcinoma
- Stage IIA Gastric Cancer
- Esophageal Squamous Cell Carcinoma Stage IIB
- Esophageal Adenocarcinoma
- Stage III Gastric Cancer
- Esophageal Cancer (Stage IV)
- Stage IVC Colorectal Cancer
- Stage 0 Colorectal Cancer
- Stage II Colorectal Cancer
- Stage III Colorectal Cancer
- Stage IVA Colorectal Cancer
- Stage IV Gastric Cancer
- Pathologic Stage 0 Gastric Cancer
- Stage IB Pancreatic Cancer
- Pathologic Stage 0 Esophageal Squamous Cell Carcinoma
- Esophageal Squamous Cell Carcinoma (Stage III)
- Esophageal Squamous Cell Carcinoma Stage III
- Stage IIB Gastric Cancer
- Clinical Stage 0 Gastric Cancer
- Pathologic Stage IA Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma Stage IVA
- Clinical Stage 0 Esophageal Adenocarcinoma
- Clinical Stage I Gastric Cancer
- Stage II Gastric Cancer
- Pathologic Stage 0 Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma (Stage IVA)
- Clinical Stage 0 Esophageal Squamous Cell Carcinoma
- Pathologic Stage I Esophageal Adenocarcinoma
- Esophageal Adenocarcinoma Stage IIB
- Esophageal Squamous Cell Carcinoma (Stage IV)
- Stage IVA Gastric Cancer
- Pathologic Stage II Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma Stage II
- Stage 0 Pancreatic Cancer
- Stage IVB Gastric Cancer
- Pathologic Stage IB Gastric Cancer
- Pathologic Stage IIA Esophageal Adenocarcinoma
- Stage IIIA Gastric Cancer
- Stage IIB Pancreatic Cancer
- Stage IV Pancreatic Cancer
- Esophageal Squamous Cell Carcinoma (Stage IVB)
- Pathologic Stage I Gastric Cancer
- Pathologic Stage IA Esophageal Squamous Cell Carcinoma
- Pathologic Stage IA Gastric Cancer
- Esophageal Squamous Cell Carcinoma Stage IIIA
- Pathologic Stage IIA Esophageal Squamous Cell Carcinoma
- Stage I Pancreatic Cancer
- Stage IA Pancreatic Cancer
- Stage II Pancreatic Cancer
- Stage IIA Pancreatic Cancer
- Stage III Pancreatic Cancer
- Stage IV Colorectal Cancer
- Esophageal Squamous Cell Carcinoma, Stage IVB
- Stage IIB Colorectal Cancer
- Stage IIIB Colorectal Cancer
- Stage IVB Colorectal Cancer
- Esophageal Squamous Cell Carcinoma Stage IIIB
- Stage IIIB Gastric Cancer
- Stage IIIA Colorectal Cancer
- Stage I Colorectal Cancer
- Stage IIA Colorectal Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
14 Primary · 0 Secondary · Reporting Duration: Through study completion, an average of 2 months
Baseline
Medical information
Prior to start of chemotherapy treatment
Information and support needs
Month 2
Post-intervention evaluation
Month 2
Acceptability
Acceptability of the RT-CAMSS
Comorbidities
Engagement of the RT-CAMSS
Feasibility and Engagement
Feasibility of the Real-Time Chemo-Associated side effects Monitoring Support System (RT-CAMSS)
Functional Assessment of Cancer Treatment - General scale
Quality of life
Self-efficacy
Social support
Symptom distress
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Health Services Research (RT-CAMSS)
1 of 1
Experimental Treatment
65 Total Participants · 1 Treatment Group
Primary Treatment: Patient Monitoring System · No Placebo Group · Phase 1 & 2
Health Services Research (RT-CAMSS)Experimental Group · 3 Interventions: Patient Monitoring System, Questionnaire Administration, Consultation · Intervention Types: Other, Other, Other
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2 months
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
416 Previous Clinical Trials
136,749 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,279 Previous Clinical Trials
41,234,793 Total Patients Enrolled
Kuang-Yi Wen, MDPrincipal InvestigatorThomas Jefferson University Hospital, Philadelphia, PA 19107 USA
1 Previous Clinical Trials
340 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Are there any opportunities for volunteers to join this clinical experiment at the moment?
"Affirmative. Clinicaltrials.gov states that this research is recruiting participants since it was initially published on April 15th 2020, and the last edit occured on September 7th 2022. The trial aims to recruit 65 patients from a single site." - Anonymous Online Contributor
Unverified Answer
What is the scope of participation in this trial?
"Affirmative. Clinicaltrials.gov data verifies that this research trial, which first went live on April 15th 2020, is currently soliciting participants. 65 patients are being sought from a single medical centre." - Anonymous Online Contributor
Unverified Answer