Intervention to Improve Follow-up of Abnormal Pap Test
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00575510 |
|
Recruitment Status :
Completed
First Posted : December 18, 2007
Results First Posted : August 15, 2014
Last Update Posted : August 23, 2018
|
Sponsor:
The University of Texas Medical Branch, Galveston
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cervical Cancer | Behavioral: Intervention Behavioral: Active control | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 341 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | Intervention to Improve Follow-up of Abnormal Pap Test |
| Study Start Date : | October 2005 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Cervical Cancer Screening
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention
Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Behavioral: Intervention
Multiple component intervention based in the unified theory of behavior |
|
Active Comparator: Active Control
nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
|
Behavioral: Active control
Partial intervention (full intervention minus cultural-specific component) |
|
No Intervention: Standard Care Only
Clinical standard of care at time of study
|
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- State Trait Anxiety Inventory (STAI)-State Scale [ Time Frame: + 7-30 days post-intervention ]State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.
Exclusion Criteria:
- Women who are currently pregnant
- Have a current diagnosis of cervical cancer; or
- Who are unable to understand English or Spanish.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575510
Locations
| United States, Texas | |
| University of Texas Medical Branch | |
| Galveston, Texas, United States, 77555 | |
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Carmen R Breitkopf, PhD | University of Texas Medical Branch, Galveston |
Publications of Results:
| Responsible Party: | The University of Texas Medical Branch, Galveston |
| ClinicalTrials.gov Identifier: | NCT00575510 |
| Other Study ID Numbers: |
05-245 R01CA107015 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 18, 2007 Key Record Dates |
| Results First Posted: | August 15, 2014 |
| Last Update Posted: | August 23, 2018 |
| Last Verified: | July 2018 |
Keywords provided by The University of Texas Medical Branch, Galveston:
|
unified theory of behavior Pap test cervical dysplasia women's health |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |