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

Sponsors

Lead Sponsor: Thomas Jefferson University

Collaborator: National Cancer Institute (NCI)

Source Thomas Jefferson University
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) 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.

Overall Status Recruiting
Start Date April 15, 2020
Completion Date April 23, 2025
Primary Completion Date October 23, 2024
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Feasibility of the Real-Time Chemo-Associated side effects Monitoring Support System (RT-CAMSS) Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Engagement of the RT-CAMSS Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Acceptability of the RT-CAMSS Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Quality of life Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Symptom distress Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Self-efficacy Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Information and support needs Prior to start of chemotherapy treatment
Comorbidities Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Enrollment 65
Condition
Intervention

Intervention Type: Other

Intervention Name: Patient Monitoring System

Description: Receive RT-CAMSS

Arm Group Label: Health Services Research (RT-CAMSS)

Intervention Type: Other

Intervention Name: Questionnaire Administration

Description: Complete questionnaires

Arm Group Label: Health Services Research (RT-CAMSS)

Intervention Type: Other

Intervention Name: Consultation

Description: Receive tailored feedback, including consultation with nurse

Arm Group Label: Health Services Research (RT-CAMSS)

Other Name: Consult

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Kuang-Yi Wen, MD Principal Investigator Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA
Overall Contact

Last Name: Kuang-Yi Wen, MD

Phone: 215-503-4623

Email: [email protected]

Location
Facility: Status: Contact: Thomas Jefferson University Hospital Carolyn Loch 215-955-9244 [email protected]
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Health Services Research (RT-CAMSS)

Type: Experimental

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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: 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.

Primary Purpose: Health Services Research

Masking: None (Open Label)

Source: ClinicalTrials.gov