CancerNCT00822822
Evaluation of Patient Functionality and Utility of Web-Based Personal Health History and Risk Assess
An observational study of Cancer and Cancer Screening Patients, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this research study is to find out what Moffitt and Lifetime patients think of the electronic medical records process. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cancer Screening Patients, Patient Volunteers
- What is being tested?
- First Questionnaire, Health History and Second Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Nov 2009
- Phase
- Observational
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People receiving services at Moffitt Cancer Center or Lifetime Cancer Screening Center
Who may be able to join
- The breakdown of patients recruited by stratified dimensional sampling. Overall, we will attempt to equally recruit patients from the unique strata for each domain evaluation in this study. Patients health status will be determined by the ECOG Performance status . We assume that all patients being seen at the Lifetime Cancer Screening and Prevention center will be of good to fair health, while patients seen at the Cancer hospital will range from good- to- fair to poor health status. Gender is also used as a sampling factor because there are modules within this web-based health history forms that are specific for each gender.
Who cannot join
- Respondents who refuse to participate or who become too ill at any point in the assessment, will be excluded. Non-English speaking patients will be excluded. Names and other identifying information will not be collected and all data will be reported in aggregate form. Due to the nature of our stratified samples strategy, some patients will be excluded if they meet the criteria for a recruitment stata, but that stata is full.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Evaluation of Patient Functionality and Utility of Web-Based Personal Health History and Risk Assessment
The purpose of this research study is to find out what Moffitt and Lifetime patients think of the electronic medical records process.
Read the detailed description
Patient will complete a questionnaire about their knowledge of computers and how long they think it will take them to finish the patient health history using a computer.
Patient will complete the electronic record carefully and tell us if they had any difficulties, questions or comments about the format.
Patient will answer a questionnaire about how well they liked or did not like using the electronic system to give their health history.
Participation in this study will take approximately 30 minutes to 1 hour.
- Conditions
- Cancer, Cancer Screening Patients, Patient Volunteers
- Being tested
- First Questionnaire, Health History, Second Questionnaire
- Keywords
- Questionnaire, Electronic Health History
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First QuestionnaireBehavioural
Complete questionnaire before completing health history
Health HistoryBehavioural
Complete electronic health history
Second QuestionnaireBehavioural
Complete questionnaire after completing electronic health history
| Study group | Role | What they receive |
|---|---|---|
| A | Health History Process Receives: Behavioral: First Questionnaire; Behavioral: Health History; Behavioral: Second Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create a system for collecting patient health histories that may be beneficial to patients and people receiving services at Moffitt Cancer Center or Lifetime Cancer Screening Center
Measured: 1 hour per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startMar 2006
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Siegel, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822822
- Sponsor's protocol ID
- MCC-14731
- Other IDs
- 104330
- Status last verified
- Oct 2010
- First submitted
- 13 Jan 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Functionality and Utility of Web-Based Personal Health History and Risk Assessment
- ClinicalTrials.gov ID
- NCT00822822
- Acronym / sponsor ID
- MCC-14731
- Conditions
- Cancer, Cancer Screening Patients, Patient Volunteers
- Keywords
- Questionnaire, Electronic Health History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Jan 2009 (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.
The purpose of this research study is to find out what Moffitt and Lifetime patients think of the electronic medical records process.
Detailed description
Patient will complete a questionnaire about their knowledge of computers and how long they think it will take them to finish the patient health history using a computer.
Patient will complete the electronic record carefully and tell us if they had any difficulties, questions or comments about the format.
Patient will answer a questionnaire about how well they liked or did not like using the electronic system to give their health history.
Participation in this study will take approximately 30 minutes to 1 hour.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: First Questionnaire, Behavioral: Health History, Behavioral: Second QuestionnaireHealth History Process |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People receiving services at Moffitt Cancer Center or Lifetime Cancer Screening Center
Key inclusion criteria (1 listed)
- The breakdown of patients recruited by stratified dimensional sampling. Overall, we will attempt to equally recruit patients from the unique strata for each domain evaluation in this study. Patients health status will be determined by the ECOG Performance status . We assume that all patients being seen at the Lifetime Cancer Screening and Prevention center will be of good to fair health, while patients seen at the Cancer hospital will range from good- to- fair to poor health status. Gender is also used as a sampling factor because there are modules within this web-based health history forms that are specific for each gender.
Key exclusion criteria (1 listed)
- Respondents who refuse to participate or who become too ill at any point in the assessment, will be excluded. Non-English speaking patients will be excluded. Names and other identifying information will not be collected and all data will be reported in aggregate form. Due to the nature of our stratified samples strategy, some patients will be excluded if they meet the criteria for a recruitment stata, but that stata is full.
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 |
|---|---|---|
| First QuestionnaireComplete questionnaire before completing health history | Behavioural | A |
| Health HistoryComplete electronic health history | Behavioural | A |
| Second QuestionnaireComplete questionnaire after completing electronic health history | Behavioural | A |
Primary outcome
Create a system for collecting patient health histories that may be beneficial to patients and people receiving services at Moffitt Cancer Center or Lifetime Cancer Screening Center
Time frame: 1 hour per participant
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 25 Nov 2013.
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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.
Erin Siegel, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Cancer Screening Patients, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Create a system for collecting patient health histories that may be beneficial to patients and people receiving services at Moffitt Cancer Center or Lifetime Cancer Screening Center (time frame: 1 hour per participant). 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 25 Nov 2013.