Increasing Cervical Cancer Screening Uptake Among Emergency Department Patients
Invasive cervical cancer is preventable with adequate screening but screening rates are considerably below national goals. Emergency departments care for a disproportionate number of women who are not up to date with recommended cervical cancer screening. This study will evaluate the effectiveness of a mobile technology based behavioral intervention (using text messaging prompts) to increase cervical cancer screening uptake among emergency department patients.
Inclusion Criteria
- female
- age 21 - 65 years
- demonstrating decisional capacity to consent to participate
Exclusion Criteria
- past hysterectomy with cervical removal
- the absence of a cervix (i.e. in patient that is a transwoman
- known infection with HIV (as screening recommendations for women with HIV differ from the general population)
- inability to consent (e.g., lacking decisional capacity, intoxicated, or in distress)
- non-English/Spanish/American Sign Language (ASL) speaking (Spanish and ASL interpreter services are available 24/7 in our system and will be paid for through grant funds)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04374760.
Locations matching your search criteria
United States
New York
Rochester
Cervical cancer (CC) is preventable. Screening for CC aims to identify treatable lesions
prior to the development of invasive CC which, without screening, is often first detected
at a stage when comfort care is all that can be offered. Still, only 80% of U.S. women
age 21 - 65 report adherence to U.S. Preventive Services Task Force (USPSTF) CC screening
recommendations. This rate is considerably below the Healthy People 2020 target of 93%8.
Lower rates of screening have been particularly pronounced among racial and ethnic
minorities and patients with lower education levels. The group most likely to be
non-adherent with screening guidelines is women who use the emergency department (ED) for
their usual source of care. The ED setting, therefore, is optimal for the deployment of
an intervention to promote CC screening. Although designed to address acute illnesses and
injuries, the ED is an effective environment to advance preventive health. Numerous
preventive health interventions have been successfully deployed in the ED including
smoking cessation, HIV testing, and depression screening. Interventions delivered in the
ED often suffer from lack of follow up and hence low adherence. Novel approaches are
needed to reinforce health messages delivered in the acute context of the ED. Short
Message Service (SMS) on mobile phones, also known as text messaging, is a low-cost,
scalable, and effective means of delivering health behavior interventions. According to
the Pew Research Center, the vast majority of Americans - 95% - own a cell phone, and an
estimated 98% of all cell phones have texting capabilities. Evidence-based SMS
interventions for health behavior include smoking cessation,primary care attendance,
breast cancer screening, and sun safety, among others. However, minimal research has been
conducted applying SMS interventions to CC screening and no prior research, apart from
our pilot work, has targeted a CC prevention intervention by leveraging the universal
healthcare access setting of the ED. In 2018-19 the investigators conducted a randomized
clinical trial pilot (ClinicalTrials.gov #NCT03483610; NIH Grant ID: UL1TR002001) among
ED patients non-adherent with USPSTF recommendations comparing an SMS intervention group
to a referral-only control group to improve CC screening uptake at follow-up. The
intervention consisted of a series of text messages, grounded in behavioral change
theory, aimed at generating intention to get screened. The results of this pilot: (A)
demonstrated the feasibility of our approach, (B) showed preliminary evidence of
efficacy, and (C) provided an effect size estimate. Our overarching goal is to develop a
low-cost, scalable SMS intervention that increases CC screening uptake among ED patients
and can be deployed in heterogenous ED settings. The proposed randomized controlled trial
will test the efficacy of this intervention. Step 1 of our approach is to identify
whether the participant is adherent with screening guidelines. Step 2 is to randomize
non-adherent participants to one of the two treatment conditions: (1) referral only
(control) or, (2) referral and an SMS-intervention consisting of a series of text
messages, grounded in behavioral change theory, aimed at generating intention and
autonomous motivation to get screened. To limit costs and increase the scalability of the
intervention, determination of adherence with screening guidelines via a
self-administered questionnaire on a tablet computer will be evaluated. A total of 1,460
non-adherent women, age 21-65, will be recruited from a high-volume urban ED and a
low-volume rural ED, randomized among study conditions, and followed-up at 150 days to
assess interval CC screening uptake.
Aim 1: Compare CC screening uptake between SMS intervention and control groups.
Hypothesis 1: Uptake of CC screening in the SMS intervention group will be greater than
in the control group at 150-day follow-up.This aim will determine the efficacy of the
intervention.
Aim 2: Compare the impact of in-person (using research staff) versus self-administered
(using a tablet) determination of CC screening adherence on the efficacy of the
intervention.
Hypothesis 2: The method of determining adherence will not impact the efficacy of the
intervention. This aim will evaluate an approach to limit cost and increase the
scalability of intervention implementation. Aim 3: Identify mediators and explore
moderators of intervention effects on CC screening uptake at follow-up.
Hypothesis 3: Uptake in the intervention group will be mediated by theory-posited
proximal predictors. This aim will elucidate the mechanism of behavioral change resulting
from the intervention and identify differential effects among study sub-groups.
This project leverages the universal access setting of the ED to target women most at
risk for non-adherence with CC screening guidelines. A low-cost, scalable intervention
that increases CC screening uptake in this population would decrease CC incidence and
save lives. Our next step would be a multi-site effectiveness trial using the NCI
Community Oncology Research Program (NCORP) Network.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUniversity of Rochester
- Primary IDSTUDY00004765
- Secondary IDsNCI-2021-08694, 1R01CA246626, 1R01CA246626-01A1
- ClinicalTrials.gov IDNCT04374760