Increasing Cervical Cancer Screening Uptake Among Emergency Department Patients

NCT04374760 | Completed

• 2 other identifiers: STUDY000047651R01CA246626
• Study Type: interventional
• Target: 1,116
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cervical Cancer

Keywords

screening adherence

Outcome Measures

Primary Outcomes (1)

• Rate of screening for cervical cancer

  The investigators will perform logistic regression comparing the treatment and control conditions on CC screening uptake (defined as either receiving CC screening or scheduling CC screening) at followup. The use of logistic regression, rather than a χ² test of independence, allows for (a) the inclusion of potential relevant covariates in the unlikely case of baseline group differences and (b) the examination of moderation/interaction in later primary analyses. Given the sample size of 1,460 non-adherent participants, the investigators will have power of 0.80 to observe an improvement in CC screening uptake of 19% as observed in the pilot study (i.e., 36% vs 43%). This is a conservative estimate of the anticipated effect size given the increased intervention intensity, incorporation of additional theoretically informed messages to participants, and the above-mentioned failures in randomization that occurred with our small pilot sample.

  150 days

Secondary Outcomes (1)

• Self-administered vs in-person baseline technique

  150 days

Study Arms (4)

in-person control

NO INTERVENTION

Usual care, initial screening measures conducted in-person in the Emergency Department.

Self-Administered Control

NO INTERVENTION

Usual care, initial screening measures conducted on their own via an iPad.

In-person Treatment

EXPERIMENTAL

Treatment group (receives text messages), initial screening measures conducted in-person in the Emergency Department.

Behavioral: SMS-intervention

Self-Administered Treatment

EXPERIMENTAL

Treatment group (receives text messages), initial screening measures conducted on their own via an iPad.

Behavioral: SMS-intervention

Interventions

SMS-intervention BEHAVIORAL

SMS-intervention consisting of a series of text messages, grounded in behavioral change theory, aimed at generating intention and autonomous motivation to get screened.

In-person Treatment; Self-Administered Treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• age 21 - 65 years
• demonstrating decisional capacity to consent to participate

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Nicolas Noyes Community Hospital

Dansville, New York, 14437, United States

Location

Strong Memorial Hospital Emergency Department

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• David Adler, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Emergency Medicine Research; Professor of Emergency Medicine & Public Health Sciences

Model Details: Randomized controlled clinical trial with a prospectively collected convenience sample of 1,460 women nonadherent with CC screening guidelines. Women aged 21-65 will be recruited from a high-volume urban ED and a low-volume rural ED, assigned to study conditions, and followed-up at 150 days to assess interval uptake of CC screening (primary outcome). Electronic Health Record (EHR) review will be conducted to assess screening results and subsequent clinical endpoints. A two-step randomization process will be used to achieve a 2 x 2 factorial design.

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: December 3, 2020
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)