Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
- Conditions
- Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage I Gastric Cancer AJCC v8Clinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8Clinical Stage I Esophageal Adenocarcinoma AJCC v8Clinical Stage 0 Gastric Cancer AJCC v8Clinical Stage IIA Gastric Cancer AJCC v8Pathologic Stage 0 Gastric Cancer AJCC v8Pathologic Stage I Esophageal Adenocarcinoma AJCC v8
- Interventions
- Other: Patient Monitoring SystemOther: Questionnaire AdministrationOther: Consultation
- Registration Number
- NCT04449679
- Lead Sponsor
- 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) 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- < 18 years of age
- Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Health Services Research (RT-CAMSS) Questionnaire Administration 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. Health Services Research (RT-CAMSS) Patient Monitoring System 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. Health Services Research (RT-CAMSS) Consultation 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 Outcome Measures
Name Time Method Social support 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.
Feasibility and Engagement 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.
Acceptability 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.
Symptom distress 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.
Self-efficacy 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.
Information and support needs 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.
Medical information Baseline Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation.
Functional Assessment of Cancer Treatment - General scale 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.
Post-intervention evaluation 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States