Stage IV Pancreatic Cancer AJCC v8 Clinical Trial
Official title:
There Is No Place Like Home- A Pragmatic Effectiveness Trial of Technology-Enhanced Outpatient Symptom Management to Reduce Acute Care Visits Due to Chemotherapy-Related Adverse Events
This clinical trial studies if enhanced outpatient symptom management with telemedicine and remote monitoring can help reduce acute care visit due to chemotherapy-related adverse events. Receiving telemedicine and remote monitoring may help patients have better outcomes (such as fewer avoidable emergency room visits and hospitalizations, better quality of life, fewer symptoms, and fewer treatment delays) than patients who receive usual care.
| Status | Recruiting |
| Enrollment | 750 |
| Est. completion date | January 31, 2026 |
| Est. primary completion date | January 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Adults (= 18 years) - English- and Spanish-fluent participants with thoracic and/or gastrointestinal cancers who are scheduled to initiate or continue outpatient chemotherapy at either MDACC (Texas Medical Center campus and any Houston-area location) or MDACC oncology clinic at Lyndon B Johnson (LBJ) hospital - Their adult (=18 years) patient-identified or self-identified primary caregivers (MDACC only) - Participants on combination chemotherapy and immunotherapy or combination chemotherapy and biologic will also be eligible for inclusion. - Participants may participate if they do not have a caregiver, or if their caregiver declines participation; however, caregivers of MDACC participants may participate only if the participant consents. Exclusion Criteria: - Participants who are receiving investigational new drug treatments or concurrently enrolled in a phase 1 clinical trial will be excluded due to the associated structured reporting and regulatory requirements. - Participants with a requirement for inpatient infusion (i.e. CAR-T cell therapy), living in institutional settings (i.e. prison, nursing homes), with a history of dementia, physical disability or neurological deficits that prohibit ability to report symptom burden will also be excluded. |
| Country | Name | City | State |
|---|---|---|---|
| United States | M D Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of acute care visits | Defined as the proportion of unique oncology patients with emergency room visits or hospital admission over a 3-month period. | Up to 3 months | |
| Secondary | Change in health-related quality of life (HRQOL) | HRQOL will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Profile-29 version 2.1. | Baseline to 6 months | |
| Secondary | Change in patient engagement | Patient engagement will be evaluated with the 13-item Patient Activation Measure (PAM), which assesses knowledge, skill, and self-efficacy for self-management of health | Baseline to 6 months | |
| Secondary | Change in symptom management | Daily symptoms will be measured using the Common Terminology Criteria for Adverse Events version 5. | Baseline to 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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