Cervical CancerNCT05131581
Strategies to Improve the Experience of Gynaecological Screening
A study testing Changed clinical context, Extra time allotted and RLP-information in people with Cervical Cancer, run by Uppsala University at 1 site in Sweden.
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)… Read more about this study
- Who is it for?
- Ages 23 to 23 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Changed clinical context, Extra time allotted and RLP-information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2021to 19 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 23 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Persons with cervix
- 23 years of age
- Visiting midwife for their first cervical screening test
Who cannot join
- Non-Swedish-speaking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The First Visit for Gynaecological Screening - How do we Make it as Valuable as Possible?
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Changed clinical context, Extra time allotted, RLP-information
- Keywords
- Health promotion, Patient experience, Cervical screening test
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changed clinical contextOther
Changed clinical context: from midwifery clinic to youth clinic
Extra time allottedBehavioural
Extra time allotted for each visit for CST
RLP-informationBehavioural
Midwife-initiated discussion of the Reproductive Life Plan
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Changed clinical context |
| Group 3 | Experimental | Standard care for CST at the youth clinic with extra time allotted (intervention group 2) Receives: Other: Changed clinical context; Behavioral: 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) Receives: Other: Changed clinical context; Behavioral: Extra time allotted; Behavioral: RLP-information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Nov 2021
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Sophiahemmet University, Sormland County Council, Sweden
- Responsible party
- Principal investigator, Jenny Stern, Uppsala University
- Investigators
- Jenny Stern, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131581
- Sponsor's protocol ID
- UU-RLP-Cellprov-2021
- Status last verified
- Jan 2025
- First submitted
- 1 Nov 2021
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Visit for Gynaecological Screening - How do we Make it as Valuable as Possible?
- ClinicalTrials.gov ID
- NCT05131581
- Acronym / sponsor ID
- UU-RLP-Cellprov-2021
- Conditions
- Cervical Cancer
- Keywords
- Health promotion, Patient experience, Cervical screening test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Sophiahemmet University, Sormland County Council, Sweden
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Standard care for cervical screening test (CST) at the midwifery clinic (control group) |
| Group 2 | Experimental | Other: Changed clinical contextStandard care for CST at the youth clinic (intervention group 1) |
| Group 3 | Experimental | Other: Changed clinical context, Behavioral: Extra time allottedStandard care for CST at the youth clinic with extra time allotted (intervention group 2) |
| Group 4 | Experimental | Other: Changed clinical context, Behavioral: Extra time allotted, Behavioral: RLP-informationStandard care for CST at the youth clinic with extra time allotted and the RLP-information (intervention group 3) |
Who may qualify
- Ages
- 23 to 23 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Persons with cervix
- 23 years of age
- Visiting midwife for their first cervical screening test
Key exclusion criteria (1 listed)
- Non-Swedish-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Changed clinical contextChanged clinical context: from midwifery clinic to youth clinic | Other | Group 2, Group 3, Group 4 |
| Extra time allottedExtra time allotted for each visit for CST | Behavioural | Group 3, Group 4 |
| RLP-informationMidwife-initiated discussion of the Reproductive Life Plan | Behavioural | Group 4 |
Primary outcome
Experience of CST
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
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
3 secondary outcomes
Knowledge of and attitudes towards CST and cervical cancer
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
Attitude towards contacting a midwife regarding sexual and reproductive health in the future
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny Stern, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changed clinical context, Extra time allotted and RLP-information in people with Cervical Cancer, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of CST (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.