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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-07

Study Completion Date

2024-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

What is the Optimal Training Model for Cervical Awareness?

NCT06562595

HPV Infection Cervical Cancer Cervical Dysplasia

COMPLETED NA

Clinic or Self-Sampling for Cervical Cancer Screening

NCT06177236

Cervical Cancer HPV Infection

COMPLETED NA

Evaluation of the Effectiveness of the Video Prepared to Raise Cervical Cancer Awareness in Women Between the Ages of 18 and 65 Via Social Media.

NCT05385172

Being a Woman Aged 18-65

COMPLETED

Effect of Nurse Navigation Program on Cervical Cancer Screening Behaviour of the Women Aged 30-65

NCT06647992

Cervical Cancers

ENROLLING_BY_INVITATION NA

Impact of the Different Information Channels in Reducing Anxiety in Participants of Cervical Cancer Screening

NCT05622760

Uterine Cervical Neoplasms Early Detection of Cancer Anxiety +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer Fear Cervical Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Awareness-Based Coping with Fear of Cancer Programme

Intervention Type BEHAVIORAL

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No