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Clinical Trial Summary

This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy. II. Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study. III. To gather preliminary data on the impact of RT-CAMSS on patient's quality of life and symptom distress. OUTLINE: PHASE I: Patients participate in an audio-recorded focus group or one-on-one interview over 40 minutes either in-person, over the phone, or electronically. Patients receive sample text messages and questionnaires generated from the RT-CAMSS to generate reaction, discussion, and scenarios. PHASE II: Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse. After completion of study, patients are followed up at 1 and 2 months. ;


Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Squamous Cell
  • Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage 0 Gastric Cancer AJCC v8
  • Clinical Stage I Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage I Gastric Cancer AJCC v8
  • Clinical Stage II Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage II Gastric Cancer AJCC v8
  • Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IIA Gastric Cancer AJCC v8
  • Clinical Stage IIB Gastric Cancer AJCC v8
  • Clinical Stage III Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage IVA Gastric Cancer AJCC v8
  • Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
  • Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
  • Clinical Stage IVB Gastric Cancer AJCC v8
  • Colorectal Neoplasms
  • Esophageal Neoplasms
  • Esophageal Squamous Cell Carcinoma
  • Pancreatic Neoplasms
  • Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage 0 Gastric Cancer AJCC v8
  • Pathologic Stage I Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage I Gastric Cancer AJCC v8
  • Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IA Gastric Cancer AJCC v8
  • Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IB Gastric Cancer AJCC v8
  • Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage II Gastric Cancer AJCC v8
  • Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIA Gastric Cancer AJCC v8
  • Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIB Gastric Cancer AJCC v8
  • Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage III Gastric Cancer AJCC v8
  • Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIIA Gastric Cancer AJCC v8
  • Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IIIB Gastric Cancer AJCC v8
  • Pathologic Stage IIIC Gastric Cancer AJCC v8
  • Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IV Gastric Cancer AJCC v8
  • Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
  • Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8
  • Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
  • Stage 0 Colorectal Cancer AJCC v8
  • Stage 0 Pancreatic Cancer AJCC v8
  • Stage I Colorectal Cancer AJCC v8
  • Stage I Pancreatic Cancer AJCC v8
  • Stage IA Pancreatic Cancer AJCC v8
  • Stage IB Pancreatic Cancer AJCC v8
  • Stage II Colorectal Cancer AJCC v8
  • Stage II Pancreatic Cancer AJCC v8
  • Stage IIA Colorectal Cancer AJCC v8
  • Stage IIA Pancreatic Cancer AJCC v8
  • Stage IIB Colorectal Cancer AJCC v8
  • Stage IIB Pancreatic Cancer AJCC v8
  • Stage IIC Colorectal Cancer AJCC v8
  • Stage III Colorectal Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IIIA Colorectal Cancer AJCC v8
  • Stage IIIB Colorectal Cancer AJCC v8
  • Stage IIIC Colorectal Cancer AJCC v8
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IVC Colorectal Cancer AJCC v8
  • Stomach Neoplasms

NCT number NCT04449679
Study type Interventional
Source Thomas Jefferson University
Contact
Status Completed
Phase N/A
Start date April 15, 2020
Completion date February 24, 2022

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