Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments internet-based intervention, assessment of therapy complications, questionnaire administration
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date December 2006
End date March 2013
Trial size 300 participants
Trial identifier NCT00417040, CALGB-70501, CDR0000521898, NCI-2009-00489, U10CA037447, UG1CA189823

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients are registered into the 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. NOTE: *All time points are based on scheduled therapy with clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-70604, CALGB-80405, or CALGB-40503.
internet-based intervention
Use the STAR database system
assessment of therapy complications
Use the STAR database system
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
Willingness of approached patients to participate in this study this study
time frame: Up to 6 years
Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit
time frame: Up to 16 weeks
Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) which a questionnaire was completed (completers:visits)
time frame: Up to 15 weeks

Secondary Outcomes

Measure
Patient-reported CTCAE symptoms using symptom severity data
time frame: At baseline (day 22)
Clinician-reported CTCAE symptoms using symptom severity data clinician reporting at day 43 (when patients report before clinicians; clinicians view those reports) vs at day 22 (patients report symptoms after the clinical encounter)
time frame: At baseline (day 22)
Mean severity scores for patient reporting at day 43
time frame: Up to day 43

Eligibility Criteria

Male participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of hormone-refractory, metastatic adenocarcinoma of the prostate - Enrolled on clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-40503, CALGB-70604, or CALGB-80405 PATIENT CHARACTERISTICS: - Able to read and comprehend English language text - Able to see a computer screen (i.e., no visual impairments) or be accompanied at visits by someone who can read the screen for the patient PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Additional Information

Official title Collection of Patient-Reported Symptoms and Performance Status Via the Internet
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.