Esophageal Cancer Clinical Trial
Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer
Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy
Able to read and understand English
Able to provide signed and dated informed consent form
Have a mobile device with text message capability
Know or willing to learn how to use text messaging
Exclusion Criteria:
< 18 years of age
Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
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There is 1 Location for this study
Philadelphia Pennsylvania, 19107, United States
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