Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients

Not Applicable

Completed

• Conditions: Vulva Cancer; Endometrial Cancer; Cervix Cancer; Grief; Uterine Cancer; Ovarian Cancer; Femininity
• Interventions: Behavioral: Such as art therapy, play therapy, breathing techniques

• Registration Number: NCT05529303
• Lead Sponsor: Kevser Pamuk

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.

Study Timeline

• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2023-02-26
• Primary Completion: 2023-05-07
• Study Completion: 2023-09-18
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Such as art therapy, play therapy, breathing techniques	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.

Primary Outcome Measures

Name	Time	Method
Prolonged Grief Disorder Score	3 months after the end of the intervention program (5.5 months)	The scale used to evaluate the emotional experiences and grief reactions of cancer patients regarding the loss caused by the disease was scored on a Likert-type scale (1=never, 5=many times a day for items 1-4.;1=never, 5=too many for items 5-12.) There are 12 items.; An increase in the total score obtained from the scale indicates an increase in grief symptoms.

Trial Locations

Locations (1)

Kevser Pamuk; 🇹🇷 Merkez, Afyon, Turkey