Strategies to Improve the Experience of Gynaecological Screening
Primary Purpose
Cervical Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Changed clinical context
Extra time allotted
RLP-information
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring Health promotion, Patient experience, Cervical screening test
Eligibility Criteria
Inclusion Criteria:
- Persons with cervix
- 23 years of age
- Visiting midwife for their first cervical screening test
Exclusion Criteria:
- Non-Swedish-speaking
Sites / Locations
- Region Sörmland
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
Standard care for cervical screening test (CST) at the midwifery clinic (control group)
Standard care for CST at the youth clinic (intervention group 1)
Standard care for CST at the youth clinic with extra time allotted (intervention group 2)
Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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.
Full Information
NCT ID
NCT05131581
First Posted
November 1, 2021
Last Updated
March 23, 2023
Sponsor
Uppsala University
Collaborators
Sophiahemmet University, Sormland County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT05131581
Brief Title
Strategies to Improve the Experience of Gynaecological Screening
Official Title
The First Visit for Gynaecological Screening - How do we Make it as Valuable as Possible?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Sophiahemmet University, Sormland County Council, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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
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.
Detailed Description
The aim is to evaluate different strategies to improve the experience and effect of the first visit for a cervical screening test (CST).
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Health promotion, Patient experience, Cervical screening test
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Standard care for cervical screening test (CST) at the midwifery clinic (control group)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Standard care for CST at the youth clinic (intervention group 1)
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Standard care for CST at the youth clinic with extra time allotted (intervention group 2)
Arm Title
Group 4
Arm Type
Experimental
Arm Description
Standard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3)
Intervention Type
Other
Intervention Name(s)
Changed clinical context
Intervention Description
Changed clinical context: from midwifery clinic to youth clinic
Intervention Type
Behavioral
Intervention Name(s)
Extra time allotted
Intervention Description
Extra time allotted for each visit for CST
Intervention Type
Behavioral
Intervention Name(s)
RLP-information
Intervention Description
Midwife-initiated discussion of the Reproductive Life Plan
Primary Outcome Measure Information:
Title
Experience of CST
Description
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
Time Frame
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 Outcome Measure Information:
Title
Knowledge of and attitudes towards CST and cervical cancer
Description
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.
Time Frame
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
Title
Attitude towards contacting a midwife regarding sexual and reproductive health in the future
Description
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
Time Frame
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
Title
Knowledge of and attitudes towards fertility and preconception health
Description
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.
Time Frame
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons with cervix
23 years of age
Visiting midwife for their first cervical screening test
Exclusion Criteria:
Non-Swedish-speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Stern, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Sörmland
City
Eskilstuna
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Strategies to Improve the Experience of Gynaecological Screening
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