Cervical Cancer
Conditions
Brief summary
The purpose of this study is to learn methods to encourage women to get recommended cervical cancer screening. Cervical cancer screening is an important part of cervical cancer prevention. The study team will determine if the patient is currently up-to-date with cervical cancer screening recommendations. If the patient is not up-to-date, then they will be randomly assigned to one of two interventions. One intervention consists only of referral to a women's health care provider to obtain cervical cancer screening. The other intervention consists of receiving a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening.
Interventions
BEHAVIORALProvider Referral
Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. At the end of the study they will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.
BEHAVIORALText Messaging
Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. They will also receive a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening. They will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.
Sponsors
National Institutes of Health (NIH)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Registered patient in the Emergency Department of the University of Rochester Medical Center * Women * Age 21 - 65
Exclusion criteria
* Past hysterectomy with cervical removal * Known infection with HIV (screening recommendations for women with HIV differ from the general population) * Non-English speaking * Inability to consent * Lack of text-capable mobile phone and/or inability to use text function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Scheduled or Completed Cervical Cancer Screening | 150 days |
Countries
United States
Participant flow
Recruitment details
All enrollment occurred over an 8 week period (June-August 2018) at a large (approximately 118,000 annual patient visits), urban, academic ED. Eligible patients were female, ages 21-65 years, and demonstrating decisional capacity to consent to participate.
Pre-assignment details
Women with past hysterectomy with cervical removal, known HIV infection, inability to consent, non-English speaking, or not having a text-capable phone were excluded. 502 eligible approached to achieve the target of 450. The primary reason for declining was lack of interest. Among consented potential-participants, 355 (79%) were adherent with screening recommendations and their participation ended. The remaining 95 participants that were determined to be eligible to be randomized.
Participants by arm
| Arm | Count |
|---|---|
| Screening and Referral Provider Referral: Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. At the end of the study they will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening. | 47 |
| Behavioral Intervention Text Messaging: Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. They will also receive a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening. They will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening. | 48 |
| Total | 95 |
Baseline characteristics
| Characteristic | Screening and Referral | Behavioral Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 48 Participants | 95 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 9 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants | 39 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 12 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) White | 27 Participants | 24 Participants | 51 Participants |
| Region of Enrollment United States | 47 participants | 48 participants | 95 participants |
| Sex: Female, Male Female | 47 Participants | 48 Participants | 95 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 48 |
| other Total, other adverse events | 0 / 47 | 0 / 48 |
| serious Total, serious adverse events | 0 / 47 | 0 / 48 |
Outcome results
Primary
Number of Participants Who Scheduled or Completed Cervical Cancer Screening
Time frame: 150 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Screening and Referral | Number of Participants Who Scheduled or Completed Cervical Cancer Screening | 28 Participants |
| Behavioral Intervention | Number of Participants Who Scheduled or Completed Cervical Cancer Screening | 21 Participants |