Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients

NCT05529303 | Completed

• 1 other identifier: AfyonkarahisarHSU-KPAMUK-1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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)

• 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)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Such as art therapy, play therapy, breathing techniques

Control group

NO INTERVENTION

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

Interventions

Such as art therapy, play therapy, breathing techniques 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kevser Pamuk: lead

Study Sites (1)

Kevser Pamuk

Merkez, Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Vulvar Neoplasms; Femininity

Interventions

Art Therapy; Play Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders; Vulvar Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Aysel Karaca

  Duzce University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation of the data will be carried out by an independent researcher who will be blinded to the intervention and control groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: February 26, 2023
• Primary Completion: May 7, 2023
• Study Completion: September 18, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

TU (1)