TrialX
Image

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

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

Recruiting
18 years and older
All
Phase 1/2

Overview

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.

Description

PRIMARY OBJECTIVES:

I. Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) and mobile platforms 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 PRIMARY OBJECTIVES:

I. Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) and mobile platforms 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

Inclusion Criteria:

  • Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer (no limitation on stage)
  • Scheduled to start chemotherapy (i.e., leucovorin plus fluorouracil and oxaliplatin [FOLFOX]); fluorouracil (5-FU) plus leucovorin, oxaliplatin and docetaxel (FLOT); 5-FU plus leucovorin, irinotecan and oxaliplatin or standard single-drug treatment plus gemcitabine (FOLFIRINOX); taxol/carboplatin plus radiotherapy) before surgery
  • Able to read and understand English
  • Able to provide signed and dated informed consent form
  • Have a mobile device with TXT capability
  • Know or willing to learn how to use TXT

Exclusion Criteria:

  • Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
  • Have symptoms from cancer itself, other diseases, or surgeries that physicians don't think appropriate for this study

Study details
    Clinical Stage IV 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 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 IV Colorectal Cancer AJCC v8
    Stage IVA Colorectal Cancer AJCC v8
    Stage IVB Colorectal Cancer AJCC v8
    Stage IVC Colorectal Cancer AJCC v8
    Clinical Stage IV Esophageal Adenocarcinoma AJCC v8
    Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
    Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
    Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8
    Stage III Pancreatic Cancer AJCC v8
    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 Squamous Cell Carcinoma AJCC v8
    Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
    Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
    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 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 IIIA Colorectal Cancer AJCC v8
    Stage IIIB Colorectal Cancer AJCC v8
    Stage IIIC Colorectal Cancer AJCC v8
    Stage IV Pancreatic Cancer AJCC v8

NCT04449679

Thomas Jefferson University

16 February 2024

Step 1 Get in touch with the nearest study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.