Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients

Ovarian Cancer Clinical Trial

Official title:

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529303
• Other study ID #: AfyonkarahisarHSU-KPAMUK-1
• Status: Completed
• Phase: N/A
• Start date: February 26, 2023
• Est. completion date: September 18, 2023

Study information

• Verified date: January 2024
• Source: Afyonkarahisar Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 18, 2023
• Est. primary completion date: May 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervix Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Grief
• Ovarian Cancer
• Uterine Cancer
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Vulva Cancer
• Vulvar Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Turkey	Kevser Pamuk	Merkez	Afyon

Sponsors (1)

Lead Sponsor	Collaborator
Kevser Pamuk

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Grief Disorder Score	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.	Before determining the intervention and control group
Primary	Prolonged Grief Disorder Score	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.	At the end of the intervention program (week 10)
Primary	Prolonged Grief Disorder Score	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.	3 months after the end of the intervention program (5.5 months)