Clinical trial NCT04449679: Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
Official title: Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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 Adenocarcinoma AJCC v8
Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IVA Gastric Cancer AJCC v8
Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8
Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8
Clinical Stage IVB Gastric Cancer 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 Adenocarcinoma AJCC v8
Pathologic Stage IV Esophageal Squamous Cell Carcinoma 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 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 III Pancreatic Cancer AJCC v8
Stage IIIA Colorectal Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Stage IIIC Colorectal Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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: SUPPORTIVE_CARE

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 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 criteria: 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)

Primary outcomes:
measure: Feasibility and Engagement
timeFrame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
measure: Acceptability
timeFrame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
measure: Symptom distress
timeFrame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
measure: Self-efficacy
timeFrame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
measure: Information and support needs
timeFrame: Prior to start of chemotherapy treatment
measure: Medical information
timeFrame: Baseline
measure: Functional Assessment of Cancer Treatment - General scale
timeFrame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
measure: Social support
timeFrame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
measure: Post-intervention evaluation
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University Hospital, Philadelphia, PA 19107 USA
name: Kuang-Yi Wen, MD
role: PRINCIPAL_INVESTIGATOR
References: