Strategies to Improve the Experience of Gynaecological Screening

Cervical Cancer Clinical Trial

Official title:

The First Visit for Gynaecological Screening - How do we Make it as Valuable as Possible?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05131581
• Other study ID #: UU-RLP-Cellprov-2021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 2023

Study information

• Verified date: March 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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. 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

Method: cluster randomised control trial evaluating the effect of different strategies, including RLP-based information, to improve the experience and effect of the first visit for a CST.

Description:

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

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. 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

The study is a cluster randomized controlled trial evaluating different strategies, RLP-based information, to improve the experience and effect of the first visit for a cervical screening test (CST). The study will be conducted in a strategically chosen area which includes both rural and urban areas, high and low socioeconomic status and high and low percentage of immigrant visitors. The study is conducted in four steps: 1. Standard care for CST at the midwifery clinic (control group) 2. Standard care for CST at the youth clinic (intervention group 1) 3. Standard care for CST at the youth clinic with extra time allotted (intervention group 2) 4. Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)

Step 2-4 will be conducted during different time periods at the same youth clinics. Recruitment for each step will be ongoing until the necessary number of participants are reached. All participating providers will be carefully instructed during educational sessions and provided with material on how to inform their visitors about the study. The providers at youth clinics will also receive oral information regarding how to execute the intervention and written materials (intervention guide, checklist) to ensure uniformity. During the project period, all providers will approach all adolescents visiting for CST and keep log over the visits to enable analysis of non-participants.

Participating adolescents in all groups will be asked to complete digital questionnaires after their visit. Primary outcomes: knowledge and awareness of CST, cervical cancer, fertility, and preconception health. Secondary outcomes: experience of the visit and likelihood to contact a midwife regarding questions about sexual or reproductive health in the future.

The power calculation is based on results by Stern et al. (2013) showing that university students increased knowledge by 40% after an RLP-intervention. The calculation assumed both greater variety in and lower increase in knowledge among adolescents than among university students. To detect a difference between the intervention and control group with 80% power and with a significance level of p< 0.05, 50 adolescents are needed in each group. We expect high participation rate and plan to recruit 75 adolescents in each group, i.e. 300 adolescents.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 23 Years

Eligibility

Inclusion Criteria:

• Persons with cervix

• 23 years of age

• Visiting midwife for their first cervical screening test

Exclusion Criteria:

• Non-Swedish-speaking

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Changed clinical context
Changed clinical context: from midwifery clinic to youth clinic

Behavioral:
• Extra time allotted
Extra time allotted for each visit for CST
• RLP-information
Midwife-initiated discussion of the Reproductive Life Plan

Locations

Country	Name	City	State
Sweden	Region Sörmland	Eskilstuna

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Sophiahemmet University, Sormland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge of and attitudes towards CST and cervical cancer	The outcome is measured through self-reported data, collected through a digital questionnaire. The item is developed based on previous research regarding knowledge of and attitudes towards CST and cervical cancer. The item is posed as 13 statements and the respondent is asked to tick the alternative that apply to her opinion: highly agree, partially agree, neither agree nor diagree, partially disagree, highly disagree, don't know.	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	Attitude towards contacting a midwife regarding sexual and reproductive health in the future	The outcome is measured through self-reported data, collected through a digital questionnaire. The item is formulated as the following "If you have questions about sexual and reproductive health in the future, how likely are you to turn to…midwife at the youth clinic? midwife at the midwifery clinic? nurse/doctor at the health center? 1177/UMO/YOUMO?" With the response alternatives: Very likely / Fairly likely / Neither likely nor unlikely / Fairly unlikely / Very unlikely	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	Knowledge of and attitudes towards fertility and preconception health	The outcome is measured through self-reported data, collected through a digital questionnaire. The item is developed based on the Health Belief Model and previous research on 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