NCT05131581

Brief Summary

The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).

  1. 1.How do the context and the allotted time for the first visit for a CST affect women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer and iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future
  2. 2.What effects do the RLP have, when used as a starting point for counselling at the first visit for a CST, on women's i) experience of CST ii) knowledge of and attitudes towards CST and cervical cancer iii) attitude towards contacting a midwife regarding sexual and reproductive health in the future and iv) knowledge of and attitudes towards fertility and preconception health

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

November 1, 2021

Last Update Submit

January 10, 2025

Conditions

Cervical Cancer

Keywords

Health promotionPatient experienceCervical screening test

Outcome Measures

Primary Outcomes (1)

  • Experience of CST

    The outcome is measured through self-reported data, collected through a digital questionnaire. The items are developed based on Kvalitet Ur Patientens Perspektiv (KUPP), which is a widely used measure within Swedish health care to measure PREM- Patient Reported Experience Measures

    Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room

Secondary Outcomes (3)

  • Knowledge of and attitudes towards CST and cervical cancer

    Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room

  • Attitude towards contacting a midwife regarding sexual and reproductive health in the future

    Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room

  • Knowledge of and attitudes towards fertility and preconception health

    Day 1. The patients receives a QR-code to the digital questionnaire at the end of the visit and can choose when and were to fill out the questionnaire, but are encouraged to do so in the waiting room

Study Arms (4)

Group 1

NO INTERVENTION

Standard care for cervical screening test (CST) at the midwifery clinic (control group)

Group 2

EXPERIMENTAL

Standard care for CST at the youth clinic (intervention group 1)

Other: Changed clinical context

Group 3

EXPERIMENTAL

Standard care for CST at the youth clinic with extra time allotted (intervention group 2)

Other: Changed clinical contextBehavioral: Extra time allotted

Group 4

EXPERIMENTAL

Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)

Other: Changed clinical contextBehavioral: Extra time allottedBehavioral: RLP-information

Interventions

Changed clinical contextOTHER

Changed clinical context: from midwifery clinic to youth clinic

Group 2Group 3Group 4
Extra time allottedBEHAVIORAL

Extra time allotted for each visit for CST

Group 3Group 4
RLP-informationBEHAVIORAL

Midwife-initiated discussion of the Reproductive Life Plan

Group 4

Eligibility Criteria

Age23 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Persons with cervix
  • years of age
  • Visiting midwife for their first cervical screening test

You may not qualify if:

  • Non-Swedish-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Sörmland

Eskilstuna, Sweden

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jenny Stern, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Associate Professor

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 23, 2021

Study Start

November 1, 2021

Primary Completion

June 19, 2023

Study Completion

June 19, 2023

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)