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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA107015 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
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| Active Control | Active Comparator | nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
|
| Standard Care Only | No Intervention | Clinical standard of care at time of study |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Multiple component intervention based in the unified theory of behavior |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Initial Follow-up (Yes/no) | Attendance at initial appointment to follow-up abnormal Pap test result | adherence rates at initial follow-up appointment, 2 weeks to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | + 7-30 days post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen R Breitkopf, PhD | University of Texas Medical Branch, Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23730719 | Result | 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. |
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6,179 women were eligible during the recruitment period. Of these, 876 declined participation, 4,671 had a normal Pap test result, 254 did not have a Pap test performed at their clinic visit, and 378 had an abnormal Pap test result and could be randomized. Of these, 90% (341/378)were randomized into the 3-arm trial.
Face-to-face recruitment of women 18-55 years of age occurred in 6 University of Texas Medical Branch (UTMB) Regional and Maternal Child Health Program clinics from June 1, 2006-November 30, 2010. Recruitment was interrupted for a period ranging from 2 weeks to 6 months in several clinic sites due to landfall of hurricane Ike on September 13, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
| FG001 | Active Control | nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
| FG002 | Standard Care Only | Clinical standard of care at time of study |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
| BG001 | Active Control | nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Initial Follow-up (Yes/no) | Attendance at initial appointment to follow-up abnormal Pap test result | Posted | Number | percentage of patients who were adherent | adherence rates at initial follow-up appointment, 2 weeks to 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling Intervention: Multiple component intervention based in the unified theory of behavior |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carmen Radecki Breitkopf | Mayo Clinic | 507-266-0969 | radeckibreitkopf.carmen@mayo.edu |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Active control | Behavioral | Partial intervention (full intervention minus cultural-specific component) |
|
| Clinic Called Patient |
|
| Pregnancy |
|
| BG002 | Standard Care Only | Clinical standard of care at time of study |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Standard Care Only | Clinical standard of care at time of study |
|
|
| Secondary | 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) | Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions. | Posted | Mean | Standard Deviation | units on a scale | + 7-30 days post-intervention |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| EG001 | Active Control | nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling Active control: Partial intervention (full intervention minus cultural-specific component) | 0 | 114 | 0 | 114 |
| EG002 | Standard Care Only | Clinical standard of care at time of study | 0 | 113 | 0 | 113 |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |