An abnormal Pap smear and the impact of notification manner on women’s health-related quality of life, coping and awareness of human papillomavirus

ISRCTN	ISRCTN80102009
DOI	https://doi.org/10.1186/ISRCTN80102009
Secondary identifying numbers	N/A

Submission date: 22/11/2017
Registration date: 02/01/2018
Last edited: 02/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Ms Marie Rask
Scientific

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

ORCID ID	0000-0002-1569-6675

Study information

Study design	Interventional non randomised controlled study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Notification of an abnormal Pap smear: An intervention study
Study objectives	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(s)	Regional Ethics Committee for Human Research Faculty of Health Sciences Linköping University, 16/12/2015, ref: Dnr 2015/338-31
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	10/12/2015
Completion date	02/05/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Intervention gorup: 113 women, and the comparison group 122 women
Key inclusion criteria	1. Women aged 23–65-years old 2. Diagnosed with ASC-US + HR-HPV, or LSIL + HR-HPV, or HSIL
Key exclusion criteria	Diagnosed with cervical cancer.
Date of first enrolment	01/02/2016
Date of final enrolment	28/04/2017

Locations

Countries of recruitment

Sweden

Study participating centre

Women's Health Clinic, Kalmar län

Landstinget i Kalmar län
Box 601
Kalmar
391 26
Sweden

Sponsor information

Kamprad Family Foundation
Charity

Västra Esplanaden 3
Växjö
352 30
Sweden

Website	http://familjenkampradsstiftelse.se/fakta/kontakt/
"ROR"	https://ror.org/03qb1q739

Funders

Funder type

University/education

Linnéuniversitetet
Government organisation / Local government

Alternative name(s): Linnaeus University
Location: Sweden

Results and Publications

Intention to publish date	11/12/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	We plan to send the study to Acta Obstetricia et Gynecologica Scandinavica.
IPD sharing plan	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.