AttitudeNCT01267877
Patient Perception of Mammogram Guidelines
A study testing read unfavorable article prior to answering questions and read favorable article prior to answering questions in people with Attitude and Practice Guideline, run by University of Massachusetts, Worcester at 4 sites in United States.
Trial summary
The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. Read more about this study
- Who is it for?
- Ages 39 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Attitude, Practice Guideline, Breast Cancer
- What is being tested?
- read unfavorable article prior to answering questions and read favorable article prior to answering questions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2010to Jun 2010
- 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 39 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women aged 39-49 seeing their gynecologist for routine preventive care
Who cannot join
- women not aged 39-49
- women with breast cancer
- women not able to read English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UMassMemorial Medical Group- Auburn Gyn
Auburn, Massachusetts, 01501
Shrewsbury Ob-Gyn
Shrewsbury, Massachusetts, 01545
UMassMemorial Medical Group- OB-GYN
Shrewsbury, Massachusetts, 01545
Women's Health of Central Mass
Worcester, Massachusetts, 01608
About this study
The purpose of this study was to determine attitudes regarding the 2009 USPSTF Guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. The population studied was women seeing their private gynecologist for annual exams in the 39-49 year old age group.
Read the detailed description
Subjects completed a baseline questionnaire listing demographics, previous experience with mammograms, and acquaintances with breast cancer. They then were randomly assigned one of two articles (one favorable and one unfavorable) that had been published in the newspaper regarding the USPSTF breast cancer screening guidelines. Their attitudes towards the safety of the guidelines and their willingness to comply with them was then measured.
- Conditions
- Attitude, Practice Guideline, Breast Cancer
- Being tested
- read unfavorable article prior to answering questions, read favorable article prior to answering questions
- Keywords
- U.S. Preventive Services Task Force, Patient attitude, Mammogram, Guideline
- Medical subject headings
- Behavior, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
read unfavorable article prior to answering questionsOther
Also called Boston Globe, November 19, 2009; Section A17. Joan Vennochi.
article title: "Taking a hit on healthcare- why that's women's work"
read favorable article prior to answering questionsOther
Also called Washington Post; November 25, 2009. Ellen Goodman.
read "A Backlash of Mistrust"
| Study group | Role | What they receive |
|---|---|---|
| Guideline unfavorable article | Active comparator | Not described Receives: Other: read unfavorable article prior to answering questions |
| Guideline favorable article | Active comparator | Not described Receives: Other: read favorable article prior to answering questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to forgo mammograms from age 40-49
Measured: within 15 minutes of completion of reading assigned article
Secondary outcomes (3)
Do you feel that the mammogram recommendations safe?
Measured: within 15 minutes of completion of reading assigned article
Do attitudes regarding the breast cancer screening guidelines differ by acquaintance with breast cancer?
Measured: within 15 minutes of completion of reading assigned article
Does willingness to forgo mammograms in their 40's differ by previous "false alarms" with mammography?
Measured: within 15 minutes of completion of reading assigned article
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttitudeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dale Magee, M.D., M.S., Principal investigator, University of Massachusetts, WorcesterAuTumn Davidson, M.D., Study director, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267877
- Sponsor's protocol ID
- OBGYN13730
- Status last verified
- Jan 2017
- First submitted
- 22 Dec 2010
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perception of Mammogram Guidelines
- ClinicalTrials.gov ID
- NCT01267877
- Acronym / sponsor ID
- OBGYN13730
- Conditions
- Attitude, Practice Guideline, Breast Cancer
- Keywords
- U.S. Preventive Services Task Force, Patient attitude, Mammogram, Guideline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Dec 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 study was to determine attitudes regarding the 2009 USPSTF Guidelines for breast cancer screening for women in their 40's and assess the effect of one of two newspaper articles on their attitudes. The population studied was women seeing their private gynecologist for annual exams in the 39-49 year old age group.
Detailed description
Subjects completed a baseline questionnaire listing demographics, previous experience with mammograms, and acquaintances with breast cancer. They then were randomly assigned one of two articles (one favorable and one unfavorable) that had been published in the newspaper regarding the USPSTF breast cancer screening guidelines. Their attitudes towards the safety of the guidelines and their willingness to comply with them was then measured.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guideline unfavorable article | Active comparator | Other: read unfavorable article prior to answering questions |
| Guideline favorable article | Active comparator | Other: read favorable article prior to answering questions |
Who may qualify
- Ages
- 39 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women aged 39-49 seeing their gynecologist for routine preventive care
Key exclusion criteria (3 listed)
- women not aged 39-49
- women with breast cancer
- women not able to read English
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 |
|---|---|---|
| read unfavorable article prior to answering questionsAlso: Boston Globe, November 19, 2009; Section A17. Joan Vennochi.article title: "Taking a hit on healthcare- why that's women's work" | Other | Guideline unfavorable article |
| read favorable article prior to answering questionsAlso: Washington Post; November 25, 2009. Ellen Goodman.read "A Backlash of Mistrust" | Other | Guideline favorable article |
Primary outcome
Willingness to forgo mammograms from age 40-49
Time frame: within 15 minutes of completion of reading assigned article
3 secondary outcomes
Do you feel that the mammogram recommendations safe?
Time frame: within 15 minutes of completion of reading assigned article
Do attitudes regarding the breast cancer screening guidelines differ by acquaintance with breast cancer?
Time frame: within 15 minutes of completion of reading assigned article
Does willingness to forgo mammograms in their 40's differ by previous "false alarms" with mammography?
Time frame: within 15 minutes of completion of reading assigned article
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 5 Jan 2017.
Related trials for Attitude
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruiting
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Not yet recruitingPhase 1
Consciousness and Psilocybin Effects on Well-Being: The CoPEWell Study
Well-Being, Psychological, Psychedelic Experiences
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.
Dale Magee, M.D., M.S. principal investigator
University of Massachusetts, Worcester
AuTumn Davidson, M.D. study director
University of Massachusetts, Worcester
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing read unfavorable article prior to answering questions and read favorable article prior to answering questions in people with Attitude and Practice Guideline, run by University of Massachusetts, Worcester at 4 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?
The sponsor lists 1 inclusion and 3 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 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 to forgo mammograms from age 40-49 (time frame: within 15 minutes of completion of reading assigned article). 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 5 Jan 2017.