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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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 groups in NCT00575510
Study groupRoleWhat they receive
InterventionExperimentalCulturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Receives: Behavioral: Intervention
Active ControlActive comparatornontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
Receives: Behavioral: Active control
Standard Care OnlyNo interventionClinical standard of care at time of study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted18 Dec 2007 (estimated)
  2. Study startOct 2005
  3. Primary completionApr 2012
  4. Study completionApr 2012

Resources

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)
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
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

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.

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