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

May 14, 2025 updated by: Thomas Jefferson University

Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Services Research (RT-CAMSS)
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.
Other: Questionnaire Administration
Complete questionnaires
Other: Patient Monitoring System
Receive RT-CAMSS
Other: Consultation
Receive tailored feedback, including consultation with nurse
Other Names:
  • Consult

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Engagement
Time Frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured through study accrual, attrition, and system usage frequencies. We aim for accrual at a rate of 50% to match our prior study but a rate over 30% will be feasible. The intervention will be considered feasible if attrition does not exceed 30%. 90% of participants reporting their symptoms at least once will be considered adequate.
Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Acceptability
Time Frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured through a satisfaction measure and patient interview data. Acceptability will be established by a group median score >= 3 on the 1-4 satisfaction scale.
Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Symptom distress
Time Frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
The Memorial Symptom Assessment Scale (MSAS), a well-validated instrument that will be used to assess common physical symptoms concerning chemotherapy in patients. The MSAS measures the prevalence, frequency, severity, and distress of 25 physical symptoms and seven psychological symptoms.
Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Self-efficacy
Time Frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Will be measured using the Patient Activation Measure (PAM) for assessing skills, knowledge and self-confidence for self-management. The scale asks participants concerning their certainty of controlling symptoms caused by chemotherapy to perform daily activities.
Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Information and support needs
Time Frame: Prior to start of chemotherapy treatment
Will be measured using the Cancer Treatment Scale (CaTS). The CaTS assesses patient's preparation prior to the start of their chemotherapy treatment.
Prior to start of chemotherapy treatment
Medical information
Time Frame: Baseline
Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation.
Baseline
Functional Assessment of Cancer Treatment - General scale
Time Frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Questionnaire will be used to assess patient quality of life. The 27-item FACT-G assesses four specific domains including physical, social, emotional and functional well-being.
Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Social support
Time Frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
The Multidemensional Scale of Perceived Social Support (MSPSS), a well-validated 12-item instrument used to assess patient perceived social support.
Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Post-intervention evaluation
Time Frame: Through study completion, an average of 2 months
Patient interviews will explore key domains including perceived usefulness, how well the enhanced usual care and the RT-CAMSS address their concerns, whether there are additional issues they would like to see included and the characteristics of the text message.
Through study completion, an average of 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Kuang-Yi Wen, MD, Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2020

Primary Completion (Actual)

February 24, 2022

Study Completion (Actual)

February 24, 2022

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20G.090
  • JT 15039 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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