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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417040
• Other study ID #: CALGB-70501
• Secondary ID: CDR0000521898NCI
• Status: Completed
• Phase: N/A
• First received: December 27, 2006
• Last updated: June 26, 2017
• Start date: December 2006
• Est. completion date: June 1, 2017

Study information

• Verified date: June 2017
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: June 1, 2017
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Leukemia
• Lung Cancer
• Multiple Myeloma
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• internet-based intervention
Use the STAR database system
• assessment of therapy complications
Use the STAR database system
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mission Hospitals - Memorial Campus	Asheville	North Carolina
United States	CancerCare of Maine at Eastern Maine Medical Center	Bangor	Maine
United States	Mountainview Medical	Berlin Corners	Vermont
United States	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	Southeast Cancer Center	Cape Girardeau	Missouri
United States	East Bay Radiation Oncology Center	Castro Valley	California
United States	Valley Medical Oncology Consultants - Castro Valley	Castro Valley	California
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care	Concord	New Hampshire
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Cancer Centers of the Carolinas - Easley	Easley	South Carolina
United States	CCOP - Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Elkhart Clinic, LLC	Elkhart	Indiana
United States	Elkhart General Hospital	Elkhart	Indiana
United States	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana
United States	Union Hospital of Cecil County	Elkton	Maryland
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Valley Medical Oncology	Fremont	California
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Bon Secours St. Francis Health System	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina
United States	Cancer Centers of the Carolinas - Grove Commons	Greenville	South Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	Greenville Hospital Cancer Center	Greenville	South Carolina
United States	Self Regional Cancer Center at Self Regional Medical Center	Greenwood	South Carolina
United States	Cancer Centers of the Carolinas - Greer Medical Oncology	Greer	South Carolina
United States	New Hampshire Oncology - Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Veterans Affairs Medical Center - Iowa City	Iowa City	Iowa
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Goldschmidt Cancer Center	Jefferson City	Missouri
United States	North Kansas City Hospital	Kansas City	Missouri
United States	Parvin Radiation Oncology	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Saint Luke's Cancer Institute at Saint Luke's Hospital	Kansas City	Missouri
United States	St. Joseph Medical Center	Kansas City	Missouri
United States	Truman Medical Center - Hospital Hill	Kansas City	Missouri
United States	Howard Community Hospital	Kokomo	Indiana
United States	La Grange Memorial Hospital	La Grange	Illinois
United States	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana
United States	Lakes Region General Hospital	Laconia	New Hampshire
United States	Monter Cancer Center of the North Shore-LIJ Health System	Lake Success	New York
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Saint Luke's East - Lee's Summit	Lee's Summit	Missouri
United States	Tunnell Cancer Center at Beebe Medical Center	Lewes	Delaware
United States	Liberty Hospital	Liberty	Missouri
United States	Norris Cotton Cancer Center at Catholic Medical Center	Manchester	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Don Monti Comprehensive Cancer Center at North Shore University Hospital	Manhasset	New York
United States	Contra Costa Regional Medical Center	Martinez	California
United States	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana
United States	Saint Joseph Regional Medical Center	Mishawaka	Indiana
United States	El Camino Hospital Cancer Center	Mountain View	California
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Michiana Hematology Oncology PC - Niles	Niles	Michigan
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	Highland General Hospital	Oakland	California
United States	Larry G Strieff MD Medical Corporation	Oakland	California
United States	Tom K Lee, Incorporated	Oakland	California
United States	Florida Hospital Cancer Institute at Florida Hospital Orlando	Orlando	Florida
United States	Menorah Medical Center	Overland Park	Kansas
United States	Saint Luke's Hospital - South	Overland Park	Kansas
United States	FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center	Pinehurst	North Carolina
United States	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana
United States	CCOP - Kansas City	Prairie Village	Kansas
United States	Miriam Hospital	Providence	Rhode Island
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	Center for Cancer Care at OSF Saint Anthony Medical Center	Rockford	Illinois
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan
United States	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan
United States	Comprehensive Cancer Care, PC	Saint Louis	Missouri
United States	Missouri Baptist Cancer Center	Saint Louis	Missouri
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Doctors Medical Center - San Pablo Campus	San Pablo	California
United States	Cancer Centers of the Carolinas - Seneca	Seneca	South Carolina
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina
United States	Iredell Memorial Hospital	Statesville	North Carolina
United States	Veterans Affairs Medical Center - Syracuse	Syracuse	New York
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Michiana Hematology Oncology PC - La Porte	Westville	Indiana
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Willingness of approached patients to participate in this study this study		Up to 6 years
Primary	Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit		Up to 16 weeks
Primary	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	Patient-reported CTCAE symptoms using symptom severity data		At baseline (day 22)
Secondary	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)
Secondary	Mean severity scores for patient reporting at day 43		Up to day 43