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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263062
• Other study ID #: women undergoing colposcopy
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2024
• Source: Alanya Alaaddin Keykubat University
• Contact: fatma ozlem uner, MSc
• Phone: +90506 297 27 49
• Email: fatma.uner[@]alanya.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer Fear
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Turkey	Alanya Alaaddin Keykubat University	Alanya

Sponsors (1)

Lead Sponsor	Collaborator
Alanya Alaaddin Keykubat University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This scale will be administered twice: pre-intervention and immediately after the intervention
Secondary	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 (a=.81) and acceptance subscale (a=.86).	This scale will be administered twice: pre-intervention and immediately after the intervention