Status:
COMPLETED
Electronic Patient Reporting of Symptoms During Cancer Treatment
Lead Sponsor:
Alliance Foundation Trials, LLC.
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
University of North Carolina
Conditions:
Metastatic Cancer
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The current study is designed to test nationally whether patients' outcomes and utilization of services can be improved through symptom monitoring via patient-reported outcomes between visits.
Detailed Description
This is a cluster RCT at approximately 50 sites where randomization will occur in a 1:1 ratio at the site level (not at the individual patient level). Therefore, approximately 25 sites will be randomi...
Eligibility Criteria
Inclusion
- Adults (21+) with metastatic cancer of any type (EXCEPT leukemia or indolent \[slow growing\] lymphoma)
- Receiving outpatient systemic cancer treatment for non-curative/palliative intent, including chemotherapy, targeted therapy, or immunotherapy.
- Enrolled at any point in their treatment trajectory, meaning during any line of treatment, and at any point during a course or cycle of treatment.
- Can understand English, Spanish, and/or Mandarin Chinese.
Exclusion
- Cognitive deficits that would preclude understanding of consent form and/or questionnaires.
- Current participation in a therapeutic clinical trial (because these often involve PRO questionnaires and intensive monitoring).
- Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast, lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).
- Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast cancer; androgen deprivation therapy in prostate cancer; or octreotide in neuroendocrine cancers)
- Indolent lymphomas (due to their prolonged time courses that may be minimally symptomatic).
- Leukemias (time courses inconsistent with other tumor types in chronic and acute leukemias).
- Does not understand English, Spanish, or Mandarin Chinese.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
1197 Patients enrolled
Trial Details
Trial ID
NCT03249090
Start Date
October 30 2017
End Date
August 30 2023
Last Update
January 14 2025
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Grand Valley Oncology
Grand Junction, Colorado, United States, 81505
2
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30046
3
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
4
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615