Cervical Cancer
Conditions
Keywords
cervical cancer
Brief summary
The purpose of this study is to see if it is possible to conduct a full study to determine whether the SoloPap™ cervical cell sample collection kit is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females. Begin to determine patient attitudes regarding ease of use and discomfort using SoloPap.
Detailed description
The SoloPap kit provides to subjects who would not otherwise have a Pap smear done a convenient and private way to collect samples and ship them to a laboratory for processing. The current study is pilot/pre-cursor study for a larger subsequent study that aims to determine whether SoloPap is truly noninferior to clinician-collected Pap smears in detecting cervical pathology. It will also determine user preference and willingness to perform a self- test.
Interventions
DEVICEPatient-Collected Cervical Pap Smear
Patient-Collected Cervical Papanicolaou Smear
Sponsors
Mike O'Callaghan Military Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Tricare Insurance Beneficiary (military insurance) receiving care at Nellis AFB * All women at least 18 yrs of presenting for Pap Smear who have not previously participated in this protocol. SoloPap can be performed any day that a woman is not having vaginal bleeding
Exclusion criteria
* Age \<18 years (not recommended for Pap Smear) * Known pregnancy * Women who have had a total hysterectomy (cervix removed) * Women with vaginal bleeding * Persons who report a history of severe neuropathy or arthritis of the hands or those having other major problems with dexterity of the hands
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests | 1 hour | whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Opinions | Directly after interventions (Solo Pap and physician-collected pap smear samples) | Results from a survey about simple subject attitudes regarding the SoloPap. Patient Solo Pap Kit Questions 1. Did you experience any discomfort while using the Solo Pap Kit? Yes / No 2. Would you use the Solo Pap Kit for future Pap Tests? Yes / No 3. Would you recommend the Solo Pap Kit to a friend or family member? Yes / No |
Countries
United States
Participant flow
Recruitment details
150 females, age \>18, without severe hand arthritis were recruited at the Mike O'Callaghan Military Medical Center (formerly Mike O'Callaghan Federal Hospital). The first participant was enrolled January 19, 2011 and the last patient enrolled was September 1, 2011.
Pre-assignment details
Of the 150 participants enrolled, 146 participants received all study interventions (comparison of a self-collected Pap smear with Physician-collected samples).
Participants by arm
| Arm | Count |
|---|---|
| Solopap and Physician-collected Pap Smear females, age \>18, without severe hand arthritis | 146 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Solopap and Physician-collected Pap Smear |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 146 Participants |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 150 |
| other Total, other adverse events | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
Primary
Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests
whether the SoloPap™ cervical cell sample collection kit used by the subject (patient) is as good as a clinician performed Pap test in detecting precancerous cervical lesions in females.
Time frame: 1 hour
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Self Pap Smear and Physician Collected Pap Smear | Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests | positive+positve | 8 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests | negative+negative | 89 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests | positive MD + negative solo | 2 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Concordance of Pap Test Results Between Self- and Physician-collected Pap Tests | positive solo+negative MD | 3 Participants |
Secondary
Patient Opinions
Results from a survey about simple subject attitudes regarding the SoloPap. Patient Solo Pap Kit Questions 1. Did you experience any discomfort while using the Solo Pap Kit? Yes / No 2. Would you use the Solo Pap Kit for future Pap Tests? Yes / No 3. Would you recommend the Solo Pap Kit to a friend or family member? Yes / No
Time frame: Directly after interventions (Solo Pap and physician-collected pap smear samples)
Population: 146 females recruited from an outpatient clinic in a military treatment facility, age \>18, without severe hand arthritis who completed both the Solo Pap and physician-collected pap smear.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | use solopap in future | no response | 44 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | recommend solopap | yes | 97 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | discomfort while using solopap | yes | 36 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | discomfort while using solopap | no | 65 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | discomfort while using solopap | no response | 45 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | use solopap in future | yes | 91 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | use solopap in future | no | 11 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | recommend solopap | no | 4 Participants |
| Self Pap Smear and Physician Collected Pap Smear | Patient Opinions | recommend solopap | no response | 45 Participants |