Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04449679
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2020-05-13
Brief Title:
Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers RT-CAMSS Study
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None