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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	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:	300
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 300 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

Show 95 Study Locations

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

ClinicalTrials.gov Identifier:	NCT00417040 History of Changes
Other Study ID Numbers:	CDR0000521898, CALGB-70501
Study First Received:	December 27, 2006
Last Updated:	August 23, 2011
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012