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SMS-based Summons in Cervical Screening

Primary Purpose

Cervical Cancer, Uterine Cervical Neoplasm, Uterine Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sending of screening summon.
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring participation, self sampling, screening

Eligibility Criteria

33 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women resident in Region Skane who either: 1) have had glandular cell transformation that has not been followed-up, 2) are older than 65 years and have had cell transformation that has not been followed-up or who have not participated in screening during the last 10 years, 3) women who have not been screened for more than 15 years.

Exclusion Criteria:

  • No exclusion except those who do not consent.

Sites / Locations

  • Southern RegionRecruiting
  • Northern RegionRecruiting
  • Western RegionRecruiting
  • Region of Stockholm-GotlandRecruiting
  • Region of Middle SwedenRecruiting
  • Southeast RegionRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HPV self sampling test ordered

Arm Description

An invitation to order a HPV self sampling test through an online application will be sent by SMS

Outcomes

Primary Outcome Measures

Proportion of women responding to summon
Participation rate in screening after summons.

Secondary Outcome Measures

Number of positive screens
Screening test results
Rate of precursors of cancer
Cytologically and histopathologically confirmed percursors of cervical cancer.
Rate of cancer
Histopathologically confirmed cervical cancers.

Full Information

First Posted
August 18, 2019
Last Updated
April 4, 2023
Sponsor
Karolinska Institutet
Collaborators
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT04061967
Brief Title
SMS-based Summons in Cervical Screening
Official Title
Can SMS-reminders Result in Increased Participation in Cervical Screening?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
June 1, 2030 (Anticipated)
Study Completion Date
June 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Skane

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
Prevention of cervical cancer with cervical screening (gynecological cell test) is one of the most successful screening activities in medicine. In Sweden screening has taken place since the 1960s and prevented tens of thousands of women from having cervical cancer. There are strong reasons why it is especially important to promote that invitations to sampling really is reaching out. The women who regularly attend screening after the invitation reduce their risk of cervical cancer by as much as 90%. Of the women who currently have cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. Current national estimate of how many in the population participating as recommended is 82.9% of the population. In addition, many women sometimes participate (they then get some reduced cancer risk). The highest cancer risk is among those women who have never participated as well as women who have had cell changes but have not participated. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), it works great to take a cervical sample at home if the sample is to be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken). Invitations and reminders about cervical screening are today sent out with physical letters (about 3 million letters per year in Sweden). These dispatches involve waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women recalled came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.
Detailed Description
Non-participation in the cervical screening program is the main risk factor for cervical cancer. Therefore it is important to reduce barriers to screening and facilitate participation in the screening program of cervical cancer. Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in several research studies as a way to reach women who have not responded to screening invitations. The purpose of this study is to investigate whether SMS reminders for screening attendance will increase participation compared to the current method where reminders are sent out with physical letters. In this study, approximately 20,000 women with high risk of developing cervical cancer, due to not fully participating in screening, will be invited. The women receive an SMS offer to request a self-sampling kit via the internet. The self-sampling kit comes with an instruction on how to take the sample and a postage-free answer envelope. Submitted samples are analyzed with an approved and accredited method (Cobas 4800, Roche) that analyzes for HPV 16, HPV18 and other carcinogens HPV types. For those women who are at the highest risk (previous glandular cell changes without follow-up), all HPV-positive women are referred via SMS directly to a women's clinic for investigation. HPV-negative women in this group have no increased risk and receive a text message with a calming message. Women of an age above the screening program but who have either had a cell change that is not followed up or who have not participated at all in the last 10 years are treated in the same way as in paragraph 1. Finally, the women of screening age who have not taken a cell sample for more than 15 years are identified. This group receive an SMS and HPV-positive women are referred, via SMS, for renewed sampling by a specially trained so-called dysplasia midwife. The sample is now being analyzed for both cytology and HPV. If the woman is HPV positive in both tests and in the case of deviating cytology, the woman is referred to a women's clinic. In other cases a text message with a reassuring message is sent. The study has the usual level of confidence (p <0.05 two-sided) and statistical power (80%) the ability to demonstrate an increase of participation by 3 times or more. The protocol will be piloted in the Region of Skåne in 2019 and then rolled out nationally in 2020.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Cervical Neoplasm, Uterine Neoplasms, Genital Neoplasm, Genital Neoplasm, Female, Uterine Diseases, Genital Diseases, Female, Neoplasms by Site, Neoplasms, Uterine Cervical Disease
Keywords
participation, self sampling, screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HPV self sampling test ordered
Arm Type
Other
Arm Description
An invitation to order a HPV self sampling test through an online application will be sent by SMS
Intervention Type
Other
Intervention Name(s)
Sending of screening summon.
Other Intervention Name(s)
Response to screening summon.
Intervention Description
A Cobas PCR Female swab sample packet will be sent. Response rates will be measured.
Primary Outcome Measure Information:
Title
Proportion of women responding to summon
Description
Participation rate in screening after summons.
Time Frame
Measured from the date of the summons until 12 months after the summons
Secondary Outcome Measure Information:
Title
Number of positive screens
Description
Screening test results
Time Frame
Measured from the date of the summons until 12 months after the summons
Title
Rate of precursors of cancer
Description
Cytologically and histopathologically confirmed percursors of cervical cancer.
Time Frame
Measured from the date of the summons until 12 months after the summons
Title
Rate of cancer
Description
Histopathologically confirmed cervical cancers.
Time Frame
Measured from the date of the summons until 12 months after the summons

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only women have a cervix
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women resident in Region Skane who either: 1) have had glandular cell transformation that has not been followed-up, 2) are older than 65 years and have had cell transformation that has not been followed-up or who have not participated in screening during the last 10 years, 3) women who have not been screened for more than 15 years. Exclusion Criteria: No exclusion except those who do not consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Elfström, PhD
Phone
+46(0)703816277
Email
Miriam.elfstrom@sll.se
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Andersson, PhD
Phone
+46-858581894
Email
helena.andersson.1@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Elfström, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Region
City
Lund
State/Province
Skåne
ZIP/Postal Code
221 00
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christer Borgfeldt, MD, PhD
Phone
+46 (0) 70-995 04 72
Email
Christer.Borgfeldt@med.lu.se
Facility Name
Northern Region
City
Umeå
State/Province
Västerbotten
ZIP/Postal Code
901 87
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena Silfverdal, MD, PhD
Phone
+46 90 785 03 79
Email
lena.silfverdal@regionvasterbotten.se
Facility Name
Western Region
City
Gothenburg
State/Province
Västra Götaland
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Ekeryd Andalen, MD
Phone
+46 (0) 70-082 32 88
Email
anne.ekeryd-andalen@rccvast.se
Facility Name
Region of Stockholm-Gotland
City
Stockholm
ZIP/Postal Code
112 18
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stina Fuentes, MD
Phone
+46 (0) 70-490 98 28
Facility Name
Region of Middle Sweden
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lovisa Bergengren, MD, PhD
Phone
+46 (0) 73-310 45 56
Email
lovisa.bergengren@regionorebrolan.se
Facility Name
Southeast Region
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
581 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Eriksson
Phone
+46 (0) 73-076 81 07
Email
hanna.ma.eriksson@regionostergotland.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31032904
Citation
Elfstrom KM, Sundstrom K, Andersson S, Bzhalava Z, Carlsten Thor A, Gzoul Z, Ohman D, Lamin H, Eklund C, Dillner J, Tornberg S. Increasing participation in cervical screening by targeting long-term nonattenders: Randomized health services study. Int J Cancer. 2019 Dec 1;145(11):3033-3039. doi: 10.1002/ijc.32374. Epub 2019 May 10.
Results Reference
background

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SMS-based Summons in Cervical Screening

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