Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study

Thomas Jefferson University

Status: Completed

Conditions: Stage IIB Pancreatic Cancer AJCC v8; Pathologic Stage IA Esophageal Adenocarcinoma AJCC v8; Clinical Stage I Gastric Cancer AJCC v8; Clinical Stage 0 Gastric Cancer AJCC v8; Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage 0 Pancreatic Cancer AJCC v8; Pathologic Stage III Gastric Cancer AJCC v8; Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8; Stage IIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Pathologic Stage IIIB Gastric Cancer AJCC v8; Stage I Pancreatic Cancer AJCC v8; Pathologic Stage IIIA Gastric Cancer AJCC v8; Clinical Stage IVA Gastric Cancer AJCC v8; Clinical Stage IVB Gastric Cancer AJCC v8; Pathologic Stage IV Gastric Cancer AJCC v8; Pathologic Stage IIIC Gastric Cancer AJCC v8; Pathologic Stage II Gastric Cancer AJCC v8; Pathologic Stage I Esophageal Squamous Cell Carcinoma AJCC v8; Stage IIA Colorectal Cancer AJCC v8; Stage IA Pancreatic Cancer AJCC v8; Clinical Stage IV Esophageal Adenocarcinoma AJCC v8; Pathologic Stage 0 Esophageal Adenocarcinoma AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Clinical Stage II Esophageal Adenocarcinoma AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage II Colorectal Cancer AJCC v8; Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8; Stage I Colorectal Cancer AJCC v8; Pathologic Stage 0 Gastric Cancer AJCC v8; Pathologic Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8; Stage III Pancreatic Cancer AJCC v8; Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIA Gastric Cancer AJCC v8; Clinical Stage I Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIB Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage III Gastric Cancer AJCC v8; Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIB Gastric Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8; Stage II Pancreatic Cancer AJCC v8; Clinical Stage IIB Gastric Cancer AJCC v8; Stage IB Pancreatic Cancer AJCC v8; Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIA Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8; Stage IIC Colorectal Cancer AJCC v8; Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage I Esophageal Adenocarcinoma AJCC v8; Clinical Stage IIA Gastric Cancer AJCC v8; Clinical Stage 0 Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage II Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IB Esophageal Squamous Cell Carcinoma AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Pathologic Stage I Gastric Cancer AJCC v8; Stage 0 Colorectal Cancer AJCC v8; Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8; Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage II Gastric Cancer AJCC v8; Pathologic Stage III Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IA Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage II Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IB Gastric Cancer AJCC v8; Stage III Colorectal Cancer AJCC v8; Pathologic Stage IA Gastric Cancer AJCC v8

Treatments: Other: Patient Monitoring System; Other: Questionnaire Administration; Other: Consultation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04449679

JT 15039 (Other Identifier)

20G.090

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Health Services Research (RT-CAMSS)

Experimental group

Description:

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.

Treatment:

Other: Consultation

Other: Questionnaire Administration

Other: Patient Monitoring System