Cervical Cancer
Conditions
Keywords
unified theory of behavior, Pap test, cervical dysplasia, women's health
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.
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.
Interventions
BEHAVIORALIntervention
Multiple component intervention based in the unified theory of behavior
BEHAVIORALActive control
Partial intervention (full intervention minus cultural-specific component)
Sponsors
National Cancer Institute (NCI)
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Initial Follow-up (Yes/no) | adherence rates at initial follow-up appointment, 2 weeks to 3 months | Attendance at initial appointment to follow-up abnormal Pap test result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| State Trait Anxiety Inventory (STAI)-State Scale | + 7-30 days post-intervention | State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling | 114 |
| Active Control nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling | 114 |
| Standard Care Only Clinical standard of care at time of study | 113 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Clinic Called Patient | 7 | 7 | 7 |
| Overall Study | Lost to Follow-up | 4 | 6 | 9 |
| Overall Study | Pregnancy | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Intervention | Active Control | Standard Care Only | Total |
|---|---|---|---|---|
| Age, Continuous | 27 years STANDARD_DEVIATION 7 | 28 years STANDARD_DEVIATION 8 | 29 years STANDARD_DEVIATION 8 | 28 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 114 participants | 114 participants | 113 participants | 341 participants |
| Sex: Female, Male Female | 114 Participants | 114 Participants | 113 Participants | 341 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 114 | 0 / 114 | 0 / 113 |
| serious Total, serious adverse events | 0 / 114 | 0 / 114 | 0 / 113 |
Outcome results
Primary
Adherence to Initial Follow-up (Yes/no)
Attendance at initial appointment to follow-up abnormal Pap test result
Time frame: adherence rates at initial follow-up appointment, 2 weeks to 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Adherence to Initial Follow-up (Yes/no) | 60 percentage of patients who were adherent |
| Active Control | Adherence to Initial Follow-up (Yes/no) | 54 percentage of patients who were adherent |
| Standard Care Only | Adherence to Initial Follow-up (Yes/no) | 58 percentage of patients who were adherent |
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)
Time frame: + 7-30 days post-intervention
Population: Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | State Trait Anxiety Inventory (STAI)-State Scale | 12 units on a scale | Standard Deviation 5 |
| Active Control | State Trait Anxiety Inventory (STAI)-State Scale | 11 units on a scale | Standard Deviation 4 |
| Standard Care Only | State Trait Anxiety Inventory (STAI)-State Scale | 11 units on a scale | Standard Deviation 4 |