Clinical trial NCT05529303: Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients
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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervix Cancer
Uterine Cancer
Ovarian Cancer
Endometrial Cancer
Vulva Cancer
Grief
Femininity
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Prolonged Grief Disorder-Patient Form will be administered to all gynecological cancer patients who meet the inclusion criteria. 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Prolonged Grief Disorder Score
timeFrame: Before determining the intervention and control group
measure: Prolonged Grief Disorder Score
timeFrame: At the end of the intervention program (week 10)
measure: Prolonged Grief Disorder Score
timeFrame: 3 months after the end of the intervention program (5.5 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Kevser Pamuk
state: Afyon
Study officials:
affiliation: Duzce University
name: Aysel Karaca
role: STUDY_DIRECTOR
References: