Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04374760 |
| Other study ID # |
STUDY00004765 |
| Secondary ID |
1R01CA246626 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 3, 2020 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University of Rochester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
