Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients

NCT ID: NCT05529303

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-26
• Study Completion Date: 2023-09-18

Brief Summary

The aim of this study is to determine the effect of the 'Feminine Identity Improvement Program', based on cognitive behavioral and expressive techniques applied to gynecological cancer patients, on prolonged grief reactions and the perception of femininity. The study will be conducted in a randomized controlled and qualitative type with gynecological cancer patients who completed their surgical treatment at least three months ago in the last year at Afyonkarahisar Health Sciences University Hospital.

Detailed Description

The Personal Information Form and the Prolonged Grief Disorder Scale will be used as data collection tools in the study. The Prolonged Grief Disorder Scale-Patient Form will be applied to all gynecological cancer patients who meet the inclusion criteria for the study. When the literature was examined for the planned study, we could not come across any study that used the scale to be applied or a parallel form of it. Since it will be a reliable method to perform power analysis with the values obtained by conducting a pilot study in the absence of literature reference, the power analysis process will be performed by carrying out a pilot study with a total of 30 cases. The study will be terminated if a sample number is determined to be 30 or fewer as a result of the power analysis. If the sample number exceeds 30, the number of samples will be increased as much as the difference. Accordingly, the patients with the highest prolonged grief reaction as much as the number of samples determined will be included in the study by dividing them into groups through block randomization. The intervention group determined by the randomization method will be given the 'Feminine Identity Improvement Program', based on cognitive behavioral and expressive techniques, which is structured to be 90-120 minutes once a week for 10 weeks. The program to be applied to the intervention group has been created by the researcher in line with the literature review and the necessary expert opinions were obtained. No intervention will be applied to the control group during the study. In order to determine the effect of the program, measurements will be carried out in both groups before the program (pre-test), at the end of the program (post-test-10th week), and three (3) months after the end of the program. In order to evaluate the perception of femininity, individual interviews will be conducted at the end of the program with the intervention group patients until saturation is reached. Since no scale evaluates the perception of femininity in the literature, the perceptions of femininity will be evaluated with individual interviews accompanied by the guide interview form prepared by the researchers in line with the literature. After the completion of the study, the program will be repeated with the volunteers from the control group.

Conditions

Cervix Cancer; Uterine Cancer; Ovarian Cancer; Endometrial Cancer; Vulva Cancer; Grief; Femininity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

The intervention group determined by the randomization method will be given the 'Feminine Identity Improvement Program', based on cognitive behavioral and expressive techniques, which is structured to be 90-120 minutes once a week for 10 weeks. The program to be applied to the intervention group has been created by the researcher in line with the literature review and the necessary expert opinions were obtained.

Group Type: EXPERIMENTAL

Such as art therapy, play therapy, breathing techniques

Intervention Type: BEHAVIORAL

The Cognitive Behavioral Therapy (CBT) model suggests that the individual's dysfunctional thoughts about self, the world, and/or others are based on irrational or illogical assumptions. An individual's self and his/her view of the world are central to the determination of his/her feelings and behaviors and thus can be changed through changing the individual's thoughts, feelings, and behaviors. CBT techniques are in line with the use of expressive art techniques. The common goal in both CBT and expressive arts is to achieve behavior change in the individual. An intervention program has been prepared by the researcher in line with this literature information.

Control group

No intervention will be applied to the control group during the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Such as art therapy, play therapy, breathing techniques

The Cognitive Behavioral Therapy (CBT) model suggests that the individual's dysfunctional thoughts about self, the world, and/or others are based on irrational or illogical assumptions. An individual's self and his/her view of the world are central to the determination of his/her feelings and behaviors and thus can be changed through changing the individual's thoughts, feelings, and behaviors. CBT techniques are in line with the use of expressive art techniques. The common goal in both CBT and expressive arts is to achieve behavior change in the individual. An intervention program has been prepared by the researcher in line with this literature information.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• To be in the age range of 18-65 years,
• To have been diagnosed with gynecological cancer,
• To be aware of the diagnosis of cancer,
• At least 3 (three) months have passed after the completion of the surgical treatment
• To be able to read and write
• Voluntary participation in the study.

Exclusion Criteria

• Having a diagnosis of any psychiatric disorder
• Having any disability (physical, mental, vision, hearing, speaking..)
• Being in terminal phase.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kevser Pamuk

OTHER

Sponsor Role: lead

Responsible Party

Kevser Pamuk

Instructor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Aysel Karaca

Role: STUDY_DIRECTOR

Duzce University

Locations

Kevser Pamuk

Merkez, Afyonkarahisar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AfyonkarahisarHSU-KPAMUK-1

Identifier Type: -

Identifier Source: org_study_id