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RecruitingNCT06263062Updated Feb 16, 2024

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

An interventional study of Awareness-Based Coping with Fear of Cancer Programme in Cancer Fear and Cervical Cancer, sponsored by Alanya Alaaddin Keykubat University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-16.

Sponsored by Alanya Alaaddin Keykubat University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 1 month after the study started (first participant enrolled Jan 2021, registered Feb 2024).
  • Started Jan 2021; still recruiting 5 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Cancer Fear
  • Cervical Cancer

Keywords

  • fear of cancer
  • MBSR
  • nursing
  • awareness
  • cervical cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Alanya Alaaddin Keykubat University is the lead sponsor of 44 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • No intervention
    Control group

    routine care after a colopscopy procedure Routine care will be provided by the nurse training handbook created by the researcher

Interventions

  • BehavioralAwareness-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.

06

What researchers measure

Primary outcomes

  1. The Cancer Worry Scale

    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.

    Time frame: This scale will be administered twice: pre-intervention and immediately after the intervention

Secondary outcomes

  1. Philadelphia Mindfulness Scale

    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).

    Time frame: This scale will be administered twice: pre-intervention and immediately after the intervention

07

Study locations

1 of 1 sites recruiting
  • Alanya Alaaddin Keykubat University
    Alanya, 7400, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06263062
Lead sponsor
Alanya Alaaddin Keykubat University
Responsible party
Fatma Ozlem Uner (Research Assistant, Alanya Alaaddin Keykubat University) — Principal investigator
First posted
Feb 16, 2024
Start date
Jan 7, 2021
Primary completion
Jun 15, 2024 (estimated)
Completion
Jun 15, 2024 (estimated)
Last update
Feb 16, 2024

Study contacts

fatma ozlem uner, MSc
Contact
fatma.uner@alanya.edu.tr
+90506 297 27 49
fatma ozlem uner, MSc
principal investigator · Alanya Alaaddin Keykubat University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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