Condition category
Urological and Genital Diseases
Date applied
22/11/2017
Date assigned
02/01/2018
Last edited
02/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A pap smear is a test that detects any abnormal cells on the cervix which is the entrance to the womb from the vagina. The notification of an abnormal Pap smear can create negative psychological reactions. The aim of this study is to assess if a phone call notification of an abnormal Pap smear delivered by a trained healthcare provider have an effect on women’s health-related quality of life (HRQoL) and coping, as well as women’s awareness of human papillomavirus (HPV).

Who can participate?
Women aged 23-65 years old who have an abnormal Pap smear.

What does the study involve?
Participants are allocated to one of two groups. Those in the first group are notified about their Pap smear via a phone call by a trained healthcare provider. Those in the second group receive their results from a standard letter. Participants are followed up using a questionnaire to assess their quality of life, awareness of HPV and their coping abilities.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their quality of life and coping abilities after hearing their have an abnormal pap smear. There are some questions in the questionnaire about the women's sex life, which could intrude on women's integrity. Getting a questionnaire could raise question by itself and create anxiety among the women. For this, a curator is contacted and has given her permission for anxious women to calling her.

Where is the study run from?
Women's Health Clinic, Kalmar län (Sweden)

When is the study starting and how long is it expected to run for?
December 2015 to May 2017

Who is funding the study?
Linnaeus University (Sweden)

Who is the main contact?
Ms Marie Rask

Trial website

Contact information

Type

Scientific

Primary contact

Ms Marie Rask

ORCID ID

http://orcid.org/0000-0002-1569-6675

Contact details

Department of Health and Caring Sciences
Linnaeus University
Kalmar
SE-391 82
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Notification of an abnormal Pap smear: An intervention study

Acronym

Study hypothesis

A phone call notification of an abnormal Pap smear delivered by a trained healthcare provider minimizes the negative psychological consequences of receiving the test result.

Ethics approval

Regional Ethics Committee for Human Research Faculty of Health Sciences Linköping University, 16/12/2015, ref: Dnr 2015/338-31

Study design

Interventional non randomised controlled study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

An abnormal Pap smear result. Diagnosed as ASC-US+HR-HPV, LSIL+HR-HPV or HSIL.

Intervention

Participants who have an abnormal Pap smear are consecutively recruitment from a womens health clinic. Participants are allocated to one of two groups. Those in the intervention group receive their results of their Pap smear from a phone call by a trained healthcare provider and those the control group receive a standard letter.

The intervention consists of a phone call with a trained healthcare provider notifying the abnormal Pap smear. The training includes lectures and forum play. Healthcare providers at the women’s health clinic participate in two half-day lectures. The education focuses on ethics, as well as factual knowledge about the cervical cancer screening program, HPV, abnormal Pap smear result and treatment. Thereafter, led by a drama teacher, ten of the healthcare providers participate in a one day education with forum play focused empathetic communication. Furthermore, healthcare providers are designated to notify women their abnormal Pap smear orally by phone. This phone call provides an opportunity for the women to have a dialogue with the healthcare provider and express their concerns and have questions answered. Women in the comparison group are notified about their abnormal Pap smear by an ordinary standard letter according to the routine of the women’s health clinic.

The outcomes are assessed using a self-administrated questionnaire, which the women filled out a week after they had been notified their abnormal Pap smear result.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Satisfaction with the notification manner regarding their test result is measured using the self-administrated questionnaire at week one
2. Health related quality of life is measured using the Functional Assessment of Chronic Illness Therapy-Cervical Dysplasia (FACIT-CD) and the Hospital Anxiety and Depression Scale (HADS) at week one

Secondary outcome measures

There are no secondary outcome measures.

Overall trial start date

10/12/2015

Overall trial end date

02/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged 23–65-years old
2. Diagnosed with ASC-US + HR-HPV, or LSIL + HR-HPV, or HSIL

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Intervention gorup: 113 women, and the comparison group 122 women

Participant exclusion criteria

Diagnosed with cervical cancer.

Recruitment start date

01/02/2016

Recruitment end date

28/04/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Women's Health Clinic, Kalmar län
Landstinget i Kalmar län Box 601
Kalmar
391 26
Sweden

Sponsor information

Organisation

Kamprad Family Foundation

Sponsor details

Västra Esplanaden 3
Växjö
352 30
Sweden

Sponsor type

Charity

Website

http://familjenkampradsstiftelse.se/fakta/kontakt/

Funders

Funder type

University/education

Funder name

Linnéuniversitetet

Alternative name(s)

Linnaeus University

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Results and Publications

Publication and dissemination plan

We plan to send the study to Acta Obstetricia et Gynecologica Scandinavica.

IPD sharing statement:
The women´s name or address is not expected to be made available, and it is looked up in a cabinet that only Marie Rask had access to. The data from the women´s answer in the questionnaire is imputed in the SPSS, and coded, and that dataset could be obtained from Marie Rask.

Intention to publish date

11/12/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes