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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Breast Cancer; Multiple Myeloma; Lung Cancer; Leukemia; Prostate Cancer; Colorectal Cancer

Treatments: Other: assessment of therapy complications; Other: Questionnaire Administration; Other: internet-based intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00417040

UG1CA189823 (U.S. NIH Grant/Contract)

NCI-2009-00489 (Registry Identifier)

CDR0000521898 (Registry Identifier)

U10CA037447 (U.S. NIH Grant/Contract)

CALGB-70501

Details and patient eligibility

About

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.

Full 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.

Enrollment: 325 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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325 participants in 1 patient group

(Internet-based STAR database)

Other group

Description:

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.

Treatment:

Other: internet-based intervention

Other: assessment of therapy complications

Other: Questionnaire Administration