Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening (DICRA)

Audiovisual Informative Project for the Participants of the Cervical Cancer Screening in Osakidetza

When participating in population-based screening for cervical cancer, women experience great anxiety during the weeks of waiting since they learn that they have an altered screening result until the colposcopy is performed. In this study we want to verify how anxiety decreases when the information is improved and an audiovisual support is added when giving it.

Study Overview

• Status: Recruiting
• Conditions: Uterine Cervical Neoplasms; Anxiety; Clinical Trial; Early Detection of Cancer
• Intervention / Treatment: Other: Audiovisual information; Other: Written information

Detailed Description

This study is designed as a double-blind clinical trial. Candidate patients for this study are women referred to a colposcopy consultation after an altered result of the screening test. Those women who have previously been in the colposcopy consultation or have had this test performed in a private center are excluded.

The initial recruitment is done by telephone. If they accept, they are given an appointment at the hospital one day where, after being informed again and signing the informed consent, they are randomized and assigned a group. There are 2 groups, in one they receive an envelope with the information in writing that was created in Osakidetza and is available on the website of said organization, and the other group receives a sheet with the links to the videos created for this study in the same envelope. In this way, both groups assume that they are receiving information and we avoid bias. The principal investigator is the one who carries out this phase and distributes the envelopes, but is unaware of their contents. Previously, a collaborator fills in the envelopes according to the randomization code and indicates outside the envelope the order in which they should be delivered. Only she knows the randomization code and she will not reveal it until the end of the study.

To analyze the level of anxiety, the participants will fill out 2 scales before receiving the information, and they will return them on the day of the colposcopy before performing it. The scales used are the Spielberger´s State-trait anxiety inventory (STAI) and the Cohen´s PerceivedStress Scale 14 (PSS14). The STAI scale has 40 items, scored from 0 (never) to 3 (very much) points. The final result can range between 0 and 60, higher scores are related to a higher level of anxiety. The PSS14 scale consists of 14 items with a five-point scale response format (0 is never and 4 is very often). The scale scores from 0 to 56; higher scores indicate higher perceived stress.

It will also be analyzed whether the waiting time until the colposcopy and the level of academic studies influence the level of anxiety. And the perception of the colposcopy will be analyzed, with the VAS scale, according to their level of anxiety and the way they received the information.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Del Valle, MD; Phone Number: 0034666465457; Email: david.delvallepena@osakidetza.eus

Study Locations

• Spain
  • Guipuzcoa
    • San Sebastián, Guipuzcoa, Spain, 20014
      • Recruiting
      • Donostia University Hospital
      • Contact: David Del Valle, MD; Phone Number: 0034666465457; Email: david.delvallepena@osakidetza.eus
      • Principal Investigator: David Del Valle, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients who participate in the Osakidetza cervical cancer screening program and are referred to the colposcopy consultation of the Hospital Universitario Donostia due to an altered screening test.

Exclusion Criteria:

• Patients who have previously been in the colposcopy consultation or have gone to a private center to receive information about their altered result or to undergo colposcopy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Audiovisual information; Group of participants to whom the information is given through an audiovisual medium.	Other: Audiovisual information; The information provided to this group is in audiovisual format. This information is what has been designed with the aim of reducing the level of anxiety of patients who participate in cervical cancer screening.
Placebo Comparator: Written information; Group of participants to whom the information is given through the writing that is available on the website of the health organization.	Other: Written information; The information provided to this group is in written format. This information is what is distributed to patients in the midwife's consultation and is available on the website of the health organization (Osakidetza)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the level of anxiety measured by the STAI scale according to the information format	Change in the level of anxiety according to the information format Compare the level of anxiety between who have the information in audiovisual format and who have the traditional model in written format. For the analysis we will use the STAI (described in Study description). The analysis of the results will be done by comparing the basic situation of each participant and the response to the same survey after having the information provided. On the other hand, the results of the surveys between both randomized groups will be compared after having access to the information studied.	Less than 6 weeks between the call notifying the altered result and the colposcopy
Change in the level of anxiety measured by the PSS14 scale according to the information format	Change in the level of anxiety according to the information format Compare the level of anxiety between who have the information in audiovisual format and who have the traditional model in written format. For the analysis we will use the PSS14 (described in Study description). The analysis of the results will be done by comparing the basic situation of each participant and the response to the same survey after having the information provided. On the other hand, the results of the surveys between both randomized groups will be compared after having access to the information studied.	Less than 6 weeks between the call notifying the altered result and the colposcopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of waiting time for colposcopy on anxiety measured by the STAI scale	In this secondary objective, we analyze whether the waiting time from the day the patient knows that she has an altered test until the day of the colposcopy influences the level of anxiety. Generally, the patient has to wait from 2 to 6 weeks from being notified of the altered result until the colposcopy. We are going to group the patients into 3 groups (from 0 to 2 weeks of waiting, from 2 to 4 weeks and from 4 to 6 weeks of waiting) and we will compare the results of the STAI scale to see if this factor is significant in their perception of emotional stress.	6 weeks maxium
Influence of waiting time for colposcopy on anxiety measured by the PSS14 scale	In this secondary objective, we analyze whether the waiting time from the day the patient knows that she has an altered test until the day of the colposcopy influences the level of anxiety. Generally, the patient has to wait from 2 to 6 weeks from being notified of the altered result until the colposcopy. We are going to group the patients into 3 groups (from 0 to 2 weeks of waiting, from 2 to 4 weeks and from 4 to 6 weeks of waiting) and we will compare the results of the PSS14 scale to see if this factor is significant in their perception of emotional stress.	6 weeks maxium
Influence of academic level on anxiety measured by the STAI scale	The level of anxiety obtained through the STAI scale score will be stratified in the 6 educational level categories (none, primary, secondary, high school, university or professional training) to see if there are significant differences between them.	6 weeks maxium
Influence of academic level on anxiety measured by the PSS14 scale	The level of anxiety obtained through the PSS14 scale score will be stratified in the 6 educational level categories (none, primary, secondary, high school, university or professional training) to see if there are significant differences between them.	6 weeks maxium
Change in colposcopy pain perception according to anxiety level measured by the STAI scale	We are going to analyze the pain perceived during the colposcopy, using the VAS scale (Visual Analogue Scale of pain) and we will compare them according to the level of anxiety detected in the STAI scale. We want to determine whether the perception of pain worsens at a higher level of anxiety.	6 weeks maxium
Change in colposcopy pain perception according to anxiety level measured by the PSS14 scale	We are going to analyze the pain perceived during the colposcopy, using the VAS scale (Visual Analogue Scale of pain) and we will compare them according to the level of anxiety detected in the PSS14 scale. We want to determine whether the perception of pain worsens at a higher level of anxiety.	6 weeks maxium

Collaborators and Investigators

• Sponsor: Asociacion Instituto Biodonostia
• Investigators: Principal Investigator: David Del Valle, MD, Osakidetza

Publications and helpful links

General Publications

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
• Remor E. Psychometric properties of a European Spanish version of the Perceived Stress Scale (PSS). Span J Psychol. 2006 May;9(1):86-93. doi: 10.1017/s1138741600006004.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Anticipated): November 22, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: anxiety; clinical trial; cervical cancer; cervical cancer screening; audiovisual intervention; uterine cervical neoplasms; early detection of cancer; uterine cervical cancer screening
• Additional Relevant MeSH Terms: Mental Disorders; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Anxiety Disorders
• Other Study ID Numbers: DICRA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No