Clinical Trials Directory

Trials / Completed

CompletedNCT04449679

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 Gastro-Intestinal Malignancies

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
34 (actual)
Sponsor
Thomas Jefferson University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPatient Monitoring SystemReceive RT-CAMSS
OTHERQuestionnaire AdministrationComplete questionnaires
OTHERConsultationReceive tailored feedback, including consultation with nurse

Timeline

Start date
2020-04-15
Primary completion
2022-02-24
Completion
2022-02-24
First posted
2020-06-29
Last updated
2025-05-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04449679. Inclusion in this directory is not an endorsement.