Collection of Patient-Reported Symptoms and Performance Status Via the Internet
- Conditions
- Breast CancerColorectal CancerMultiple MyelomaProstate CancerLung CancerLeukemia
- Registration Number
- NCT00417040
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Willingness of approached patients to participate in this study this study Up to 6 years Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit 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) Up to 15 weeks
- Secondary Outcome Measures
Name Time Method Patient-reported CTCAE symptoms using symptom severity data 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) At baseline (day 22) Mean severity scores for patient reporting at day 43 Up to day 43
Trial Locations
- Locations (95)
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
El Camino Hospital Cancer Center
🇺🇸Mountain View, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Larry G Strieff MD Medical Corporation
🇺🇸Oakland, California, United States
Scroll for more (85 remaining)East Bay Radiation Oncology Center🇺🇸Castro Valley, California, United States