Prostate CancerNCT00417040
Collection of Patient-Reported Symptoms and Performance Status Via the Internet
A study testing internet-based intervention, assessment of therapy complications and Questionnaire Administration in people with Prostate Cancer and Breast Cancer, run by Alliance for Clinical Trials in Oncology at 95 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Lung Cancer
- What is being tested?
- internet-based intervention, assessment of therapy complications and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 95 sitesUnited States
- Study dates
- Dec 2006to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
95 sites in 1 country.
95 sites in 1 country
United States95 sites
Mission Hospitals - Memorial Campus
Asheville, North Carolina, 28801
CancerCare of Maine at Eastern Maine Medical Center
Bangor, Maine, 04401
Mountainview Medical
Berlin Corners, Vermont, 05602
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, 02115
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
Southeast Cancer Center
Cape Girardeau, Missouri, 63703
East Bay Radiation Oncology Center
Castro Valley, California, 94546
Valley Medical Oncology Consultants - Castro Valley
Castro Valley, California, 94546
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, 03301
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Cancer Centers of the Carolinas - Easley
Easley, South Carolina, 29640
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514
Elkhart General Hospital
Elkhart, Indiana, 46515
Union Hospital of Cecil County
Elkton, Maryland, 21921
Elmhurst Hospital Center
Elmhurst, New York, 11373
Valley Medical Oncology
Fremont, California, 94538
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
Bon Secours St. Francis Health System
Greenville, South Carolina, 29601
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, 29605
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, 29605
Greenville Hospital Cancer Center
Greenville, South Carolina, 29605
CCOP - Greenville
Greenville, South Carolina, 29615
Self Regional Cancer Center at Self Regional Medical Center
Greenwood, South Carolina, 29646
Cancer Centers of the Carolinas - Greer Medical Oncology
Greer, South Carolina, 29650
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, 03106
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Veterans Affairs Medical Center - Iowa City
Iowa City, Iowa, 52246
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
Truman Medical Center - Hospital Hill
Kansas City, Missouri, 64108
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, 64111
St. Joseph Medical Center
Kansas City, Missouri, 64114
North Kansas City Hospital
Kansas City, Missouri, 64116
Parvin Radiation Oncology
Kansas City, Missouri, 64116
Research Medical Center
Kansas City, Missouri, 64132
Howard Community Hospital
Kokomo, Indiana, 46904
La Grange Memorial Hospital
La Grange, Illinois, 60525
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Lakes Region General Hospital
Laconia, New Hampshire, 03246
Monter Cancer Center of the North Shore-LIJ Health System
Lake Success, New York, 11042
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0002
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958
Liberty Hospital
Liberty, Missouri, 64068
Norris Cotton Cancer Center at Catholic Medical Center
Manchester, New Hampshire, 03102
CCOP - North Shore University Hospital
Manhasset, New York, 11030
Don Monti Comprehensive Cancer Center at North Shore University Hospital
Manhasset, New York, 11030
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470
El Camino Hospital Cancer Center
Mountain View, California, 94040
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Michiana Hematology Oncology PC - Niles
Niles, Michigan, 49120
Highland General Hospital
Oakland, California, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
Bay Area Breast Surgeons, Incorporated
Oakland, California, 94609
CCOP - Bay Area Tumor Institute
Oakland, California, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, 94609
Tom K Lee, Incorporated
Oakland, California, 94609
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, 32803-1273
Menorah Medical Center
Overland Park, Kansas, 66209
Saint Luke's Hospital - South
Overland Park, Kansas, 66213
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, 28374
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563
CCOP - Kansas City
Prairie Village, Kansas, 66208
Rhode Island Hospital Comprehensive Cancer Center
Providence, Rhode Island, 02903
Miriam Hospital
Providence, Rhode Island, 02906
Center for Cancer Care at OSF Saint Anthony Medical Center
Rockford, Illinois, 61108
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Doctors Medical Center - San Pablo Campus
San Pablo, California, 94806
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, 29672
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, 29307
Missouri Baptist Cancer Center
St Louis, Missouri, 63131
Comprehensive Cancer Care, PC
St Louis, Missouri, 63141
Iredell Memorial Hospital
Statesville, North Carolina, 28677
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
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.
Read the detailed description
This study enrolled participants who were diagnosed with breast cancer, lung cancer, colorectal cancer, leukemia and multiple myeloma and prostate cancer.
PRIMARY OBJECTIVES:
- 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
- Prostate Cancer, Breast Cancer, Lung Cancer, Colorectal Cancer, Leukemia, Multiple Myeloma
- Being tested
- internet-based intervention, assessment of therapy complications, Questionnaire Administration
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Leukemia, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based interventionOther
Use the STAR database system
assessment of therapy complicationsOther
Use the STAR database system
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| (Internet-based STAR database) | Other | 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. Receives: Other: internet-based intervention; Other: assessment of therapy complications; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness of approached patients to participate in this study this study
Measured: Up to 6 years
Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit
Measured: Up to 16 weeks
Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) which a questionnaire was completed (completers:visits)
Measured: Up to 15 weeks
Secondary outcomes (3)
Patient-reported CTCAE symptoms using symptom severity data
Measured: At baseline (day 22)
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)
Measured: At baseline (day 22)
Mean severity scores for patient reporting at day 43
Measured: Up to day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2013
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ethan Basch, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417040
- Sponsor's protocol ID
- CALGB-70501
- Other IDs
- CDR0000521898, NCI-2009-00489, UG1CA189823, U10CA037447
- Status last verified
- Jun 2017
- First submitted
- 27 Dec 2006
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Patient-Reported Symptoms and Performance Status Via the Internet
- ClinicalTrials.gov ID
- NCT00417040
- Acronym / sponsor ID
- CALGB-70501
- Conditions
- Prostate Cancer, Breast Cancer, Lung Cancer, Colorectal Cancer, Leukemia, Multiple Myeloma
- Keywords
- adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 28 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
This study enrolled participants who were diagnosed with breast cancer, lung cancer, colorectal cancer, leukemia and multiple myeloma and prostate cancer.
PRIMARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (Internet-based STAR database) | Other | Other: internet-based intervention, Other: assessment of therapy complications, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-based interventionUse the STAR database system | Other | (Internet-based STAR database) |
| assessment of therapy complicationsUse the STAR database system | Other | (Internet-based STAR database) |
| Questionnaire AdministrationAncillary studies | Other | (Internet-based STAR database) |
Primary outcome
Willingness of approached patients to participate in this study this study
Time frame: Up to 6 years
Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit
Time frame: Up to 16 weeks
Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) which a questionnaire was completed (completers:visits)
Time frame: Up to 15 weeks
3 secondary outcomes
Patient-reported CTCAE symptoms using symptom severity data
Time frame: At baseline (day 22)
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)
Time frame: At baseline (day 22)
Mean severity scores for patient reporting at day 43
Time frame: Up to day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ethan Basch, MD study chair
Memorial Sloan Kettering Cancer Center
95 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-based intervention, assessment of therapy complications and Questionnaire Administration in people with Prostate Cancer and Breast Cancer, run by Alliance for Clinical Trials in Oncology at 95 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness of approached patients to participate in this study this study (time frame: Up to 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.