Using the Internet to Collect Symptoms and the Ability to Carry Out Daily Activities From Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy - Full Text View

Sponsors and Collaborators:	Cancer and Leukemia Group B National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00417040

Purpose

RATIONALE: A study that evaluates a patient's ability to use a clinic waiting room computer to report his symptoms and his ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.

PURPOSE: This clinical trial is studying how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with metastatic prostate cancer that has not responded to hormone therapy.

Condition	Intervention
Prostate Cancer	Other: internet-based intervention Procedure: assessment of therapy complications

Study Type:	Observational
Official Title:	Collection of Patient-Reported Symptoms and Performance Status Via the Internet

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Willingness of approached patients to participate in this study [ Designated as safety issue: No ]
Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit [ Designated as safety issue: No ]
Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of patient-reported symptoms vs clinician-reported symptoms using symptom severity data collected at baseline [ Designated as safety issue: No ]
Comparison of the mean severity scores for patient vs 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) [ Designated as safety issue: No ]

Estimated Enrollment:	195
Study Start Date:	December 2006

Detailed Description:

OBJECTIVES:

Primary

Assess the feasibility of collecting symptom data directly from patients with hormone-refractory metastatic prostate cancer enrolled in a CALGB chemotherapy trial during clinic visits via waiting-area computers.

Secondary

Assess, preliminarily, the level of agreement between patient and clinician symptom severity scoring, and measure whether their scores converge when clinicians are exposed to patient self-reports.

OUTLINE: This is a multicenter, pilot study.

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.

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.

PROJECTED ACCRUAL: A total of 195 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of hormone-refractory, metastatic adenocarcinoma of the prostate
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417040

Locations

United States, Delaware
CCOP - Christiana Care Health Services	Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services 302-733-6227
Tunnell Cancer Center at Beebe Medical Center	Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center 302-645-3171
United States, Illinois
University of Chicago Cancer Research Center	Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424
United States, Indiana
Elkhart General Hospital	Recruiting
Elkhart, Indiana, United States, 46515
Contact: Rafat H. Ansari, MD, FACP 574-234-5123
Center for Cancer Therapy at LaPorte Hospital and Health Services	Recruiting
La Porte, Indiana, United States, 46350
Contact: Rafat H. Ansari, MD, FACP 574-234-5123
CCOP - Northern Indiana CR Consortium	Recruiting
South Bend, Indiana, United States, 46601
Contact: Rafat H. Ansari, MD, FACP 574-234-5123
Howard Community Hospital	Recruiting
Kokomo, Indiana, United States, 46904
Contact: Rafat H. Ansari, MD, FACP 574-234-5123
Memorial Hospital of South Bend	Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend 800-284-7370
Saint Joseph Regional Medical Center	Recruiting
South Bend, Indiana, United States, 46617
Contact: Rafat H. Ansari, MD, FACP 574-234-5123
South Bend Clinic	Recruiting
South Bend, Indiana, United States, 46617
Contact: Rafat H. Ansari, MD, FACP 574-234-5123
United States, Maryland
Union Hospital Cancer Program at Union Hospital	Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Stephen S. Grubbs, MD 302-366-1200
United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph	Recruiting
St. Joseph, Michigan, United States, 49085
Contact: Rafat H. Ansari, MD, FACP 574-234-5123
United States, Missouri
Arch Medical Services, Incorporated at Center for Cancer Care and Research	Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Alan P. Lyss, MD 314-996-5514
Missouri Baptist Cancer Center	Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD 314-996-5514
United States, Nevada
CCOP - Nevada Cancer Research Foundation	Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton, MD, CM 702-384-0013
University Medical Center of Southern Nevada	Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM 702-384-0013
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees	Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo 856-325-6757
United States, New York
CCOP - Hematology-Oncology Associates of Central New York	Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD 315-472-7504
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Ethan M. Basch 212-639-8895
Ralph Lauren Center for Cancer Care and Prevention	Recruiting
New York, New York, United States, 10035
Contact: Ethan M. Basch 212-987-1777
United States, North Carolina
Wayne Memorial Hospital, Incorporated	Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD 919-580-0000
United States, Rhode Island
Miriam Hospital	Recruiting
Providence, Rhode Island, United States, 02906
Contact: Clinical Trials Office - Miriam Hospital 401-793-2224
Rhode Island Hospital Comprehensive Cancer Center	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Ethan Basch, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000521898, CALGB-70501
Study First Received:	December 27, 2006
Last Updated:	September 5, 2009
ClinicalTrials.gov Identifier:	NCT00417040 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male

Adenocarcinoma
Hormones
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009