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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06263062
Enrollment
60
Registered
2024-02-16
Start date
2021-01-07
Completion date
2024-06-15
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Fear, Cervical Cancer

Keywords

fear of cancer, MBSR, nursing, awareness, cervical cancer

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.

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.

Sponsors

Alanya Alaaddin Keykubat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
The Cancer Worry ScaleThis scale will be administered twice: pre-intervention and immediately after the interventionThe 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

MeasureTime frameDescription
Philadelphia Mindfulness ScaleThis scale will be administered twice: pre-intervention and immediately after the interventionPhiladelphia 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).

Countries

Turkey (Türkiye)

Contacts

Primary Contactfatma ozlem uner, MSc
fatma.uner@alanya.edu.tr+90506 297 27 49

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026