Breast Cancer, Colorectal Cancer, Leukemia, Lung Cancer, Multiple Myeloma, Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
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.
Interventions
OTHERinternet-based intervention
Use the STAR database system
OTHERassessment of therapy complications
Use the STAR database system
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed