Stage IV Colorectal Cancer AJCC v8 Clinical Trial
Official title:
Real-Time Monitoring of Chemotherapy Side Effects in Patients With Gastro-Intestinal Malignancies
| Verified date | February 2024 |
| Source | Thomas Jefferson University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | February 24, 2022 |
| Est. primary completion date | February 24, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Thomas Jefferson University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Up to 2 months or until chemotherapy is discontinued, whichever is earlier | |
| Primary | 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. | Up to 2 months or until chemotherapy is discontinued, whichever is earlier | |
| Primary | 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. | Up to 2 months or until chemotherapy is discontinued, whichever is earlier | |
| Primary | 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. | Up to 2 months or until chemotherapy is discontinued, whichever is earlier | |
| Primary | 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. | Prior to start of chemotherapy treatment | |
| Primary | Medical information | Will be extracted from the electronic medical record (EMR) chart including cancer diagnosis information, treatment schedule and discontinuation. | Baseline | |
| Primary | 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. | Up to 2 months or until chemotherapy is discontinued, whichever is earlier | |
| Primary | Social support | The Multidemensional Scale of Perceived Social Support (MSPSS), a well-validated 12-item instrument used to assess patient perceived social support. | Up to 2 months or until chemotherapy is discontinued, whichever is earlier | |
| Primary | 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. | Through study completion, an average of 2 months |
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