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Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients

Primary Purpose

Cervix Cancer, Uterine Cancer, Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Such as art therapy, play therapy, breathing techniques
Sponsored by
Kevser Pamuk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervix Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Kevser PamukRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2022
Last Updated
May 16, 2023
Sponsor
Kevser Pamuk
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1. Study Identification

Unique Protocol Identification Number
NCT05529303
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 26, 2023 (Actual)
Primary Completion Date
May 7, 2023 (Actual)
Study Completion Date
August 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kevser Pamuk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervix Cancer, Uterine Cancer, Ovarian Cancer, Endometrial Cancer, Vulva Cancer, Grief, Femininity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
The evaluation of the data will be carried out by an independent researcher who will be blinded to the intervention and control groups.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be applied to the control group during the study.
Intervention Type
Behavioral
Intervention Name(s)
Such as art therapy, play therapy, breathing techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prolonged Grief Disorder Score
Description
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.
Time Frame
Before determining the intervention and control group
Title
Prolonged Grief Disorder Score
Description
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.
Time Frame
At the end of the intervention program (week 10)
Title
Prolonged Grief Disorder Score
Description
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.
Time Frame
3 months after the end of the intervention program (5.5 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevser Pamuk
Phone
05052643087
Email
kevser.pamuk@afsu.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Aysel Karaca
Phone
05054753765
Email
ayselkaraca0905@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aysel Karaca
Organizational Affiliation
Duzce University
Official's Role
Study Chair
Facility Information:
Facility Name
Kevser Pamuk
City
Merkez
State/Province
Afyon
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevser Pamuk
Phone
05052643087
Email
kevser.pamuk@afsu.edu.tr

12. IPD Sharing Statement

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Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients

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