Management With Fear of Cancer in Women Undergoing Colposcopy: Randomized Controlled Study

February 14, 2024 updated by: Fatma Ozlem Uner, Alanya Alaaddin Keykubat University

Impact of the Awareness-Based Initiation Program on Cancer Fear and Awareness Level in Women Undergoing Colposcopy: Randomized Controlled Study

Cervical cancer is the fourth most common cancer in women worldwide. Due to advances in early diagnosis and treatment, the number of survivors of cancer has increased over the past 50 years. Therefore, the current standard of care for the detection of cervical neoplasm, a Papanicolaou smear and then a colposcopic biopsy, requires a high degree of diagnostic accuracy. In particular, the fear of developing cancer after cancer screening tests is becoming an increasingly significant problem, with an impact on psychosocial health in individuals. For people who are afraid of cancer, meditation and awareness training can make it easier for emotions to self-regulate in times of distress and pain. This study aim to conducted to determine the impact of the Awareness-Based Initiation Program on cancer fear and level of awareness in women undergoing colonoscopy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Alanya, Turkey, 7400
        • Recruiting
        • Alanya Alaaddin Keykubat University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Colposcopy procedure due to HSIL, LSIL, ASC-H or HPV on cervical cytology
  • Volunteering to participate in the 6-session Mindfulness-Based Coping Programme Knowing what a colposcopy procedure means,

Exclusion Criteria:

  • interference with verbal communication,
  • being diagnosed with major depressive disorder or psychiatric disorder,
  • having participated in MBSR training or meditating before
  • Lack of skills to use smart phones and computers
  • learning biopsy results during the programme

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
routine care after a colopscopy procedure "Mindfulness-Based Coping Programme" in addition to routine care Prepared in accordance with the MBSR programme. Applied online with Zoom programme Teams in groups of 6 people 6 sessions in 2 weeks
Behavioral: Awareness-Based Coping with Fear of Cancer Programme
The content of the Training Program was created by researchers based on MBSR, in line with high-level research results and international guides.Then, the necessary arrangements were made bytaking the opinions of 10 experts ( faculty members of the department of obstetrics and gynaecology nursing, psychiatry specialist, faculty members of the gynaecology oncology department, oncology clinic psychologist, obstetrics and gynaecology clinic charge nurse). Content concluded in accordance with the comments received.
No Intervention: Control group
routine care after a colopscopy procedure Routine care will be provided by the nurse training handbook created by the researcher

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Cancer Worry Scale
Time Frame: This scale will be administered twice: pre-intervention and immediately after the intervention
The Cancer Worry Scale was developed by Custers et al. (2014) and consists of 8 items. In the Likert scale, the responses are numbered from 0 to 4. In the scale, 0 is expressed as "almost never", while 4 is expressed as "almost always". In the scoring of the scale, the lowest score is 0 and the highest score is 32. Cronbach's alpha value was determined as 0.87.
This scale will be administered twice: pre-intervention and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Philadelphia Mindfulness Scale
Time Frame: This scale will be administered twice: pre-intervention and immediately after the intervention
Philadelphia Mindfulness Scale The scale developed by Cardaciotto et al. in 2008 is a five-point Likert-type scale consisting of 20 items. The scale measures awareness skills in two different dimensions: (i) discrimination (awareness), (ii) acceptance (acceptance). In the original validity and reliability study of the scale, Cronbach's alpha value was determined as 0.85. The two sub-dimensions of the scale were determined as discrimination (α=.81) and acceptance subscale (α=.86).
This scale will be administered twice: pre-intervention and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alanya Alaaddin Keykubat University

Investigators

  • Principal Investigator: fatma ozlem uner, MSc, Alanya Alaaddin Keykubat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2021

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • women undergoing colposcopy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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