NCT00417040

Collection of Patient-Reported Symptoms and Performance Status Via the Internet

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.

Detailed description

This study enrolled participants who were diagnosed with breast cancer, lung cancer, colorectal cancer, leukemia and multiple myeloma and prostate cancer. PRIMARY OBJECTIVES: I. To assess the feasibility of collecting symptom data directly from patients at clinic visits via waiting-area computers. II. To preliminarily assess the level of agreement between patient and clinician Common Terminology Criteria for Adverse Events (CTCAE) symptom severity scoring, and to measure whether their scores converge when clinicians are exposed to patient self-reports. OUTLINE: Patients are registered into the Symptom Tracking and Reporting (STAR) database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2\* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6\* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4\* of chemotherapy. Clinicians complete feedback survey at study completion.

Conditions

• Prostate Cancer
• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Leukemia
• Multiple Myeloma

Interventions

Type	Name	Description
OTHER	internet-based intervention	Use the STAR database system
OTHER	assessment of therapy complications	Use the STAR database system
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2006-12-01
• Primary completion: 2013-03-01
• Completion: 2017-06-01
• First posted: 2006-12-28
• Last updated: 2017-06-27

Locations

95 sites across 1 country: United States