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

Not Applicable

Recruiting

• Conditions: Cancer Fear; Cervical Cancer
• Interventions: Behavioral: Awareness-Based Coping with Fear of Cancer Programme

• Registration Number: NCT06263062
• Lead Sponsor: Alanya Alaaddin Keykubat University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-14
• Last Update Submitted: 2024-02-14
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Primary Completion: 2024-06-15
• Study Completion: 2024-06-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Awareness-Based Coping with Fear of Cancer Programme	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

Primary Outcome Measures

Name	Time	Method
The Cancer Worry Scale	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.

Secondary Outcome Measures

Name	Time	Method
Philadelphia Mindfulness Scale	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).

Trial Locations

Locations (1)

Alanya Alaaddin Keykubat University; 🇹🇷 Alanya, Turkey