Cervical CancerNCT00575510
Intervention to Improve Follow-up of Abnormal Pap Test
A study testing Intervention in people with Cervical Cancer, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.
Who cannot join
- Women who are currently pregnant
- Have a current diagnosis of cervical cancer; or
- Who are unable to understand English or Spanish.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations.
Read the detailed description
Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and treatment of precursor lesions. However, 20% to 70% of women in the United States who are told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for follow-up care. This is a problem especially among minorities and women of lower socioeconomic status. The purpose of this part of the protocol is to test a theory-based intervention designed to improve adherence to follow-up among women who experience an abnormal Pap test. The intervention is a message, delivered over the telephone by a nurse, at the time Pap test results are given to patients. The investigators propose to randomize women who experience an abnormal Pap test to one of three groups: (1) targeted cultural belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge + importance (active control), or (3) standard care only (passive control). All three groups will receive standard care, which is to notify women by telephone of their abnormal results and provide instructions for follow-up. Women assigned to the intervention group also will receive a cultural belief component consistent with their racial/ethnic group, detailed information about follow-up procedures and the consequences of not returning for follow-up, and information regarding the importance of adhering to recommendations, particularly for "low grade" abnormalities. Women assigned to the active control group will receive a nontargeted belief component, plus procedural knowledge and a message on the importance of follow-up. Adherence to initial follow-up will be the primary outcome. Other behavioral outcomes, such as delayed care and completeness of care, also will be assessed over an 18-month interval by chart review. Additionally, the investigators will evaluate psychological outcomes including anxiety and distress. Finally, the investigators will examine the grade of abnormality (low versus high) as an effect modifier. The investigators anticipate that this research will result in an intervention that will improve several important behavioral and psychological outcomes related to abnormal Pap test results. The intervention is guided by a general integrative theoretical framework; therefore, this research will evaluate an intervention strategy that recognizes the importance of targeting culturally relevant beliefs about follow-up and key determinants of behavior (knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test results. Ultimately, the objective of this research is to improve adherence to follow-up among low-income, minority women who are at particular risk of developing cervical cancer.
- Conditions
- Cervical Cancer
- Being tested
- Intervention, Active control
- Keywords
- unified theory of behavior, Pap test, cervical dysplasia, women's health
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Multiple component intervention based in the unified theory of behavior
Active controlBehavioural
Partial intervention (full intervention minus cultural-specific component)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling Receives: Behavioral: Intervention |
| Active Control | Active comparator | nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling Receives: Behavioral: Active control |
| Standard Care Only | No intervention | Clinical standard of care at time of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Initial Follow-up (Yes/no)
Attendance at initial appointment to follow-up abnormal Pap test result
Measured: adherence rates at initial follow-up appointment, 2 weeks to 3 months
Secondary outcomes (1)
State Trait Anxiety Inventory (STAI)-State Scale
State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)
Measured: + 7-30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startOct 2005
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Carmen R Breitkopf, PhD, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575510
- Sponsor's protocol ID
- 05-245
- Other IDs
- R01CA107015
- Status last verified
- Jul 2018
- First submitted
- 14 Dec 2007
- Last updated
- 23 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Breitkopf CR, Dawson L, Grady JJ, Breitkopf DM, Nelson-Becker C, Snyder RR. Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial. Health Psychol. 2014 Apr;33(4):307-316. doi: 10.1037/a0032722. Epub 2013 Jun 3.
PubMed 23730719
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Improve Follow-up of Abnormal Pap Test
- ClinicalTrials.gov ID
- NCT00575510
- Acronym / sponsor ID
- 05-245
- Conditions
- Cervical Cancer
- Keywords
- unified theory of behavior, Pap test, cervical dysplasia, women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2005
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations.
Detailed description
Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and treatment of precursor lesions. However, 20% to 70% of women in the United States who are told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for follow-up care. This is a problem especially among minorities and women of lower socioeconomic status. The purpose of this part of the protocol is to test a theory-based intervention designed to improve adherence to follow-up among women who experience an abnormal Pap test. The intervention is a message, delivered over the telephone by a nurse, at the time Pap test results are given to patients. The investigators propose to randomize women who experience an abnormal Pap test to one of three groups: (1) targeted cultural belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge + importance (active control), or (3) standard care only (passive control). All three groups will receive standard care, which is to notify women by telephone of their abnormal results and provide instructions for follow-up. Women assigned to the intervention group also will receive a cultural belief component consistent with their racial/ethnic group, detailed information about follow-up procedures and the consequences of not returning for follow-up, and information regarding the importance of adhering to recommendations, particularly for "low grade" abnormalities. Women assigned to the active control group will receive a nontargeted belief component, plus procedural knowledge and a message on the importance of follow-up. Adherence to initial follow-up will be the primary outcome. Other behavioral outcomes, such as delayed care and completeness of care, also will be assessed over an 18-month interval by chart review. Additionally, the investigators will evaluate psychological outcomes including anxiety and distress. Finally, the investigators will examine the grade of abnormality (low versus high) as an effect modifier. The investigators anticipate that this research will result in an intervention that will improve several important behavioral and psychological outcomes related to abnormal Pap test results. The intervention is guided by a general integrative theoretical framework; therefore, this research will evaluate an intervention strategy that recognizes the importance of targeting culturally relevant beliefs about follow-up and key determinants of behavior (knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test results. Ultimately, the objective of this research is to improve adherence to follow-up among low-income, minority women who are at particular risk of developing cervical cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionCulturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
| Active Control | Active comparator | Behavioral: Active controlnontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
| Standard Care Only | No intervention | –Clinical standard of care at time of study |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.
Key exclusion criteria (3 listed)
- Women who are currently pregnant
- Have a current diagnosis of cervical cancer; or
- Who are unable to understand English or Spanish.
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 |
|---|---|---|
| InterventionMultiple component intervention based in the unified theory of behavior | Behavioural | Intervention |
| Active controlPartial intervention (full intervention minus cultural-specific component) | Behavioural | Active Control |
Primary outcome
Adherence to Initial Follow-up (Yes/no)
Time frame: adherence rates at initial follow-up appointment, 2 weeks to 3 months
Attendance at initial appointment to follow-up abnormal Pap test result
1 secondary outcome
State Trait Anxiety Inventory (STAI)-State Scale
Time frame: + 7-30 days post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23730719Breitkopf CR, Dawson L, Grady JJ, Breitkopf DM, Nelson-Becker C, Snyder RR. Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial. Health Psychol. 2014 Apr;33(4):307-316. doi: 10.1037/a0032722. Epub 2013 Jun 3.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Carmen R Breitkopf, PhD principal investigator
University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Cervical Cancer, run by The University of Texas Medical Branch, Galveston 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 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 23 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adherence to Initial Follow-up (Yes/no) (time frame: adherence rates at initial follow-up appointment, 2 weeks to 3 months). 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 NCT00575510, 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 23 Aug 2018.