Brain TumorNCT01130220
Study of the Health Information Needs of Brain Cancer Patients
An observational study of Brain Tumor, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research is to explore the factors involved in brain cancer health care literacy needs. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Focus Group
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2011
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited during routine interactions with the investigators.
Who may be able to join
- BRAIN TUMOR PATIENTS:
- 18 to 89 years of age
- Have or have had any type of brain tumor
- Ability to communicate in English
- Willingness to participate in a 30-60 minute focus group
- HEALTH CARE PROVIDERS:
Show all 10Show fewer
- 18 to 89 years of age
- Be a health care provider who cares for any type of brain tumor
- Ability to communicate in English
- Willingness to participate in a 30-60 minute focus group
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Informed Brain Cancer Patients
The purpose of this research is to explore the factors involved in brain cancer health care literacy needs.
Read the detailed description
A mere subset of the reasons behind unmet health care literacy needs include the health care systems' increasing complexity, increased time constraints, profound treatment decision making requirements, decreased financial resources, fracturing social networks and diversifying educational and cultural needs.
This project will use focus groups to explore the factors involved in brain cancer health care literacy from the perspectives of patients and those involved in their care. Hypothesis generated from this project will be directly applied toward future projects. The overarching goals are improved access and adequacy of health care literacy information through the eventual development of validated, useful, reliable health care literacy information tools for brain cancer patients and those involved in their care.
- Conditions
- Brain Tumor
- Being tested
- Focus Group
- Keywords
- Brain Tumor, Brain Neoplasm
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
A single focus group will be held until a "saturation" of themes has been identified.
| Study group | Role | What they receive |
|---|---|---|
| Brain Tumor Patient | A one-time focus group will be held in a quiet room for approximately 30-60 minutes until a "saturation" of themes has been identified. Receives: Other: Focus Group | |
| Health Care Provider | A one-time focus group will be held in a quiet room for approximately 30-60 minutes until a "saturation" of themes has been identified. Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Explore the factors involved in health care literacy from the perspective of brain cancer patients.
An investigator experienced in semi-structured focus group research will faclitate focus group sessions by using a generalized list of topics and open-ended discussion questions.
Measured: 1 Year
Secondary outcomes (1)
Explore the factors involved in health care literacy from the perspective of health care providers.
An investigator experienced in semi-structured focus group research will faclitate focus group sessions by using a generalized list of topics and open-ended discussion questions.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin M Dunbar, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130220
- Sponsor's protocol ID
- 708-2009
- Status last verified
- Jul 2012
- First submitted
- 24 May 2010
- Last updated
- 25 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Brain Cancer Patients
- ClinicalTrials.gov ID
- NCT01130220
- Acronym / sponsor ID
- 708-2009
- Conditions
- Brain Tumor
- Keywords
- Brain Tumor, Brain Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 May 2010 (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 is to explore the factors involved in brain cancer health care literacy needs.
Detailed description
A mere subset of the reasons behind unmet health care literacy needs include the health care systems' increasing complexity, increased time constraints, profound treatment decision making requirements, decreased financial resources, fracturing social networks and diversifying educational and cultural needs.
This project will use focus groups to explore the factors involved in brain cancer health care literacy from the perspectives of patients and those involved in their care. Hypothesis generated from this project will be directly applied toward future projects. The overarching goals are improved access and adequacy of health care literacy information through the eventual development of validated, useful, reliable health care literacy information tools for brain cancer patients and those involved in their care.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain Tumor Patient | – | Other: Focus GroupA one-time focus group will be held in a quiet room for approximately 30-60 minutes until a "saturation" of themes has been identified. |
| Health Care Provider | – | Other: Focus GroupA one-time focus group will be held in a quiet room for approximately 30-60 minutes until a "saturation" of themes has been identified. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited during routine interactions with the investigators.
Key inclusion criteria (10 listed)
- 18 to 89 years of age
- Have or have had any type of brain tumor
- Ability to communicate in English
- Willingness to participate in a 30-60 minute focus group
- 18 to 89 years of age
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Focus GroupA single focus group will be held until a "saturation" of themes has been identified. | Other | Brain Tumor Patient, Health Care Provider |
Primary outcome
Explore the factors involved in health care literacy from the perspective of brain cancer patients.
Time frame: 1 Year
An investigator experienced in semi-structured focus group research will faclitate focus group sessions by using a generalized list of topics and open-ended discussion questions.
1 secondary outcome
Explore the factors involved in health care literacy from the perspective of health care providers.
Time frame: 1 Year
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 Jul 2012.
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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 M Dunbar, MD principal investigator
University of Florida
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 Brain Tumor, run by University of Florida 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 10 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 Jul 2012. 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?
Explore the factors involved in health care literacy from the perspective of brain cancer patients. (time frame: 1 Year). 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 Jul 2012.