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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
34
Receive RT-CAMSS
Complete questionnaires
Receive tailored feedback, including consultation with nurse
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Feasibility and Engagement
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.
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Acceptability
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.
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Symptom distress
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.
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Self-efficacy
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.
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Information and support needs
Will be measured using the Cancer Treatment Scale (CaTS). The CaTS assesses patient's preparation prior to the start of their chemotherapy treatment.
Time frame: Prior to start of chemotherapy treatment
Medical information
Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation.
Time frame: Baseline
Functional Assessment of Cancer Treatment - General scale
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.
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Social support
The Multidemensional Scale of Perceived Social Support (MSPSS), a well-validated 12-item instrument used to assess patient perceived social support.
Time frame: Up to 2 months or until chemotherapy is discontinued, whichever is earlier
Post-intervention evaluation
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.
Time frame: Through study completion, an average of 2 months
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