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Brief Title: Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
Official Title: Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies
Study ID: NCT04449679
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Name: Kuang-Yi Wen, MD
Affiliation: Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA
Role: PRINCIPAL_INVESTIGATOR