Unspecified Adult Solid Tumor, Protocol SpecificNCT00387998
Health Education in Improving the Understanding of Medical Information
A study testing AHRQ staying healthy booklet and Risk primer in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Dartmouth-Hitchcock Medical Center.
Trial summary
RATIONALE: Understanding the risk of disease and prevention and screening activities to lower disease risk may help individuals make informed medical decisions. PURPOSE: This randomized clinical trial is studying how well health education materials help participants understand medical information. Read more about this study
- Who is it for?
- Ages 35 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- AHRQ staying healthy booklet and Risk primer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 555 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Aug 2005
- 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 35 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- High socioeconomic status
- Attended Dartmouth Community Medical School in the past
- Low socioeconomic status
- Veteran or family member enrolled in a Veteran Affairs clinic
PATIENT CHARACTERISTICS:
- English speaking
- No more than 1 participant per household
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Randomized Trial of a Primer to Help Patients Understand Risk
RATIONALE: Understanding the risk of disease and prevention and screening activities to lower disease risk may help individuals make informed medical decisions.
PURPOSE: This randomized clinical trial is studying how well health education materials help participants understand medical information.
Read the detailed description
OBJECTIVES:
- Compare medical data interpretation skills in participants of low or high socioeconomic status who receive a general education primer (entitled "Know Your Chances: Understanding Health Statistics") vs a health education booklet (entitled "The Pocket Guide to Good Heath for Adults").
OUTLINE: This is a randomized, controlled study. Participants are stratified according to socioeconomic status (low vs high). Participants are randomized to 1 of 2 intervention arms.
- Arm I (control): Participants receive a health education booklet entitled "The Pocket Guide to Good Health for Adults," published by the Agency for Health Care Research and Quality, which contains general information about disease risk and reducing risk by following recommended prevention or screening activities.
- Arm II (primer): Participants receive a general education primer entitled "Know your chances: Understanding health statistics," which teaches how to understand disease risk and the benefits and risks of intervention.
Within 2 weeks after receiving the education material, participants in both arms complete a survey, including a medical data interpretation test, STAT-interest, STAT-confidence, and user ratings of the education materials.
PROJECTED ACCRUAL: A total of 555 participants were accrued for this study.
- Being tested
- AHRQ staying healthy booklet, Risk primer
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHRQ staying healthy bookletOther
Also called AHRQ guide to staying healthy
educational booklet about prevention
Risk primerOther
Also called Know your chances
Know your chances booklet
| Study group | Role | What they receive |
|---|---|---|
| Risk primer | Experimental | Booklet written by investigators "know your chances" Receives: Other: Risk primer |
| Control booklet | Active comparator | AHRQ staying healthy booklet Receives: Other: AHRQ staying healthy booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to interpret medical statistics as measured by a medical data interpretation test
medical data interpretation skills
Measured: 2 weeks
Secondary outcomes (3)
Interest in interpreting medical statistics, as measured by STAT-interest
STAT-interest measure
Measured: 2 weeks
Confidence in interpreting medical statistics, measured by STAT-confidence
STAT-confidence
Measured: 2 weeks
User ratings of materials
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startOct 2004
- Primary completionAug 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven Woloshin, MD, MS, Principal investigator, White River Junction Veterans Affairs Medical CenterLisa Schwartz, MD, MS, Principal investigator, White River Junction Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00387998
- Sponsor's protocol ID
- CDR0000510867
- Other IDs
- R18CA091052, DMS-15144
- Status last verified
- Jan 2008
- First submitted
- 12 Oct 2006
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Woloshin S, Schwartz LM, Welch HG. The effectiveness of a primer to help people understand risk: two randomized trials in distinct populations. Ann Intern Med. 2007 Feb 20;146(4):256-65. doi: 10.7326/0003-4819-146-4-200702200-00004.
PubMed 17310049
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Primer to Help Patients Understand Risk
- ClinicalTrials.gov ID
- NCT00387998
- Acronym / sponsor ID
- CDR0000510867
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2005 (actual)
- First posted
- 13 Oct 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.
RATIONALE: Understanding the risk of disease and prevention and screening activities to lower disease risk may help individuals make informed medical decisions.
PURPOSE: This randomized clinical trial is studying how well health education materials help participants understand medical information.
Detailed description
OBJECTIVES:
- Compare medical data interpretation skills in participants of low or high socioeconomic status who receive a general education primer (entitled "Know Your Chances: Understanding Health Statistics") vs a health education booklet (entitled "The Pocket Guide to Good Heath for Adults").
OUTLINE: This is a randomized, controlled study. Participants are stratified according to socioeconomic status (low vs high). Participants are randomized to 1 of 2 intervention arms.
- Arm I (control): Participants receive a health education booklet entitled "The Pocket Guide to Good Health for Adults," published by the Agency for Health Care Research and Quality, which contains general information about disease risk and reducing risk by following recommended prevention or screening activities.
- Arm II (primer): Participants receive a general education primer entitled "Know your chances: Understanding health statistics," which teaches how to understand disease risk and the benefits and risks of intervention.
Within 2 weeks after receiving the education material, participants in both arms complete a survey, including a medical data interpretation test, STAT-interest, STAT-confidence, and user ratings of the education materials.
PROJECTED ACCRUAL: A total of 555 participants were accrued for this study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk primer | Experimental | Other: Risk primerBooklet written by investigators "know your chances" |
| Control booklet | Active comparator | Other: AHRQ staying healthy bookletAHRQ staying healthy booklet |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| AHRQ staying healthy bookletAlso: AHRQ guide to staying healthyeducational booklet about prevention | Other | Control booklet |
| Risk primerAlso: Know your chancesKnow your chances booklet | Other | Risk primer |
Primary outcome
Ability to interpret medical statistics as measured by a medical data interpretation test
Time frame: 2 weeks
medical data interpretation skills
3 secondary outcomes
Interest in interpreting medical statistics, as measured by STAT-interest
Time frame: 2 weeks
Confidence in interpreting medical statistics, measured by STAT-confidence
Time frame: 2 weeks
User ratings of materials
Time frame: 2 weeks
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 30 Aug 2013.
- Derived from this study: PubMed 17310049Woloshin S, Schwartz LM, Welch HG. The effectiveness of a primer to help people understand risk: two randomized trials in distinct populations. Ann Intern Med. 2007 Feb 20;146(4):256-65. doi: 10.7326/0003-4819-146-4-200702200-00004.
Related trials for Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
Recruiting
Copenhagen Prospective Personalized Oncology (CoPPO)
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
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.
Steven Woloshin, MD, MS principal investigator
White River Junction Veterans Affairs Medical Center
Lisa Schwartz, MD, MS principal investigator
White River Junction Veterans Affairs Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing AHRQ staying healthy booklet and Risk primer in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Dartmouth-Hitchcock Medical Center.
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 30 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Ability to interpret medical statistics as measured by a medical data interpretation test (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00387998, which also lists 1 linked publication.
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 30 Aug 2013.