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

NCT ID: NCT00417040

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2017-06-01

Brief Summary

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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

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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

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Prostate Cancer Breast Cancer Lung Cancer Colorectal Cancer Leukemia Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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(Internet-based STAR database)

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.

Group Type OTHER

internet-based intervention

Intervention Type OTHER

Use the STAR database system

assessment of therapy complications

Intervention Type OTHER

Use the STAR database system

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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internet-based intervention

Use the STAR database system

Intervention Type OTHER

assessment of therapy complications

Use the STAR database system

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ethan Basch, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

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East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Site Status

Valley Medical Oncology

Fremont, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

El Camino Hospital Cancer Center

Mountain View, California, United States

Site Status

Highland General Hospital

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

Bay Area Breast Surgeons, Incorporated

Oakland, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Larry G Strieff MD Medical Corporation

Oakland, California, United States

Site Status

Tom K Lee, Incorporated

Oakland, California, United States

Site Status

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Site Status

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, United States

Site Status

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Site Status

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

Site Status

La Grange Memorial Hospital

La Grange, Illinois, United States

Site Status

Center for Cancer Care at OSF Saint Anthony Medical Center

Rockford, Illinois, United States

Site Status

Elkhart Clinic, LLC

Elkhart, Indiana, United States

Site Status

Michiana Hematology-Oncology, PC - Elkhart

Elkhart, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Howard Community Hospital

Kokomo, Indiana, United States

Site Status

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

Site Status

Michiana Hematology-Oncology, PC - South Bend

Mishawaka, Indiana, United States

Site Status

Saint Joseph Regional Medical Center

Mishawaka, Indiana, United States

Site Status

Michiana Hematology Oncology PC - Plymouth

Plymouth, Indiana, United States

Site Status

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Michiana Hematology Oncology PC - La Porte

Westville, Indiana, United States

Site Status

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

Veterans Affairs Medical Center - Iowa City

Iowa City, Iowa, United States

Site Status

Menorah Medical Center

Overland Park, Kansas, United States

Site Status

Saint Luke's Hospital - South

Overland Park, Kansas, United States

Site Status

CCOP - Kansas City

Prairie Village, Kansas, United States

Site Status

CancerCare of Maine at Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Union Hospital of Cecil County

Elkton, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, United States

Site Status

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Michiana Hematology Oncology PC - Niles

Niles, Michigan, United States

Site Status

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, United States

Site Status

Lakeside Cancer Specialists, PLLC

Saint Joseph, Michigan, United States

Site Status

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status

Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Site Status

Truman Medical Center - Hospital Hill

Kansas City, Missouri, United States

Site Status

Saint Luke's Cancer Institute at Saint Luke's Hospital

Kansas City, Missouri, United States

Site Status

St. Joseph Medical Center

Kansas City, Missouri, United States

Site Status

North Kansas City Hospital

Kansas City, Missouri, United States

Site Status

Parvin Radiation Oncology

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Saint Luke's East - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

Liberty Hospital

Liberty, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Missouri Baptist Cancer Center

St Louis, Missouri, United States

Site Status

Comprehensive Cancer Care, PC

St Louis, Missouri, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care

Concord, New Hampshire, United States

Site Status

New Hampshire Oncology - Hematology, PA - Hooksett

Hooksett, New Hampshire, United States

Site Status

Lakes Region General Hospital

Laconia, New Hampshire, United States

Site Status

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Norris Cotton Cancer Center at Catholic Medical Center

Manchester, New Hampshire, United States

Site Status

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

Site Status

CCOP - Hematology-Oncology Associates of Central New York

East Syracuse, New York, United States

Site Status

Elmhurst Hospital Center

Elmhurst, New York, United States

Site Status

Queens Cancer Center of Queens Hospital

Jamaica, New York, United States

Site Status

Monter Cancer Center of the North Shore-LIJ Health System

Lake Success, New York, United States

Site Status

CCOP - North Shore University Hospital

Manhasset, New York, United States

Site Status

Don Monti Comprehensive Cancer Center at North Shore University Hospital

Manhasset, New York, United States

Site Status

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Veterans Affairs Medical Center - Syracuse

Syracuse, New York, United States

Site Status

Mission Hospitals - Memorial Campus

Asheville, North Carolina, United States

Site Status

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Site Status

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, United States

Site Status

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, United States

Site Status

Iredell Memorial Hospital

Statesville, North Carolina, United States

Site Status

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status

Rhode Island Hospital Comprehensive Cancer Center

Providence, Rhode Island, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

Cancer Centers of the Carolinas - Easley

Easley, South Carolina, United States

Site Status

Bon Secours St. Francis Health System

Greenville, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Grove Commons

Greenville, South Carolina, United States

Site Status

Greenville Hospital Cancer Center

Greenville, South Carolina, United States

Site Status

CCOP - Greenville

Greenville, South Carolina, United States

Site Status

Self Regional Cancer Center at Self Regional Medical Center

Greenwood, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Greer Medical Oncology

Greer, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, United States

Site Status

Cancer Centers of the Carolinas - Spartanburg

Spartanburg, South Carolina, United States

Site Status

Mountainview Medical

Berlin Corners, Vermont, United States

Site Status

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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CDR0000521898

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2009-00489

Identifier Type: REGISTRY

Identifier Source: secondary_id

UG1CA189823

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA037447

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CALGB-70501

Identifier Type: -

Identifier Source: org_study_id

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