Effect of Motivational Interviewing on Posttraumatic Stress Symptoms and Posttraumatic Growth in Women with Endometrial Cancer

NCT06781216 | Not Yet Recruiting

• 1 other identifier: AkdenizzUniversityy
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer is still the second leading cause of death worldwide with approximately 9.6 million deaths per year. Gynecological cancers, which are the most common type of cancer among women, significantly affect the quality of life by disrupting the functions of the reproductive system of women. Endometrial cancer has an important place due to its prevalence in our country and worldwide. Although stress factors related to endometrial cancer may continue after the completion of treatment, this situation has the potential to negatively affect the psychological and physiological health of women. This research is a randomized controlled trial aiming to evaluate the effect of motivational interviewing applied to women who completed endometrial cancer treatment and were followed up in the outpatient clinic on post-traumatic stress symptoms and post-traumatic growth. Simple randomization method will be used in the study. The sample size to be included in the study was determined as 66 participants in total, 33 in the intervention group and 33 in the control group. In the study, the effectiveness of motivational interviewing technique application in women with endometrial cancer will be evaluated based on evidence using Post-Traumatic Stress Disorder Checklist for DSM-5, Post-Traumatic Growth Scale and Ways of Coping Scale. Research data will be collected from women who meet the inclusion criteria at Akdeniz University Hospital Gynecology and Obstetrics Clinic between January 2 and August 31, 2025. The motivational interviews planned to be implemented as an intervention method in the research aim to reduce post-traumatic stress symptoms, develop coping strategies and increase the level of post-traumatic growth in women with endometrial cancer.

Conditions

Endometrium Cancer; Post Traumatic Stress Symptoms; Post Traumatic Growth, Psychological

Keywords

Endometrium cancer; Motivational interviewing; Post traumatic growth; Post traumatic stress symptoms

Outcome Measures

Primary Outcomes (3)

• Post-Traumatic Stress Disorder Checklist Scale for DSM-5

  The Post-Traumatic Stress Disorder Checklist was developed to measure the symptoms of Post-Traumatic Stress Disorder and the degree of these symptoms according to the DSM-5 diagnostic criteria. The Turkish validity and reliability of the scale was conducted by Boysan et al. in 2017. The scale, which evaluates the severity of post-traumatic stress disorder symptoms experienced by an individual in the last month after a very stressful event, consists of 20 items. The scale is a 5-point Likert-type scale and is scored as not at all = 0, very little = 1, moderately = 2, quite a lot = 3 and extremely = 4. The scores obtained from the scale range from 0 to 80, and increasing scores indicate increasing post-traumatic stress disorder symptom severity. Permission was received from the corresponding author to use the scale in research. Permission was received from the corresponding author to use the scale in research.

  * "through study completion, an average of 1 year"

• Post-Traumatic Growth Scale

  The Posttraumatic Growth Scale was developed by Tedeschi and Calhoun in 1996 and revised in 2017. The revised Turkish version of the scale was adapted to cancer patients by Aydın and Kabukcuoğlu (2020). The scale consists of 23 items and five factors. The factors are spiritual and existential change, change in life and self-perception, personal power, new opportunities, and relationships with others. The items are scored on a 6-point Likert-type scale ranging from 0 = never experienced to 5 = experienced a lot, with higher scores indicating greater posttraumatic growth. The lowest score that can be obtained from the scale is 0 and the highest score is 115. The overall Cronbach's α of the scale was calculated as 0.93. The scale was determined to be a reliable and valid tool for Turkish cancer patient. Permission was obtained from the relevant author to use the scale in the research.

  "through study completion, an average of 1 year"

• Ways of Coping Scale

  The coping strategies scale was first developed by Folkman and Lazarus in 1980 with 66 items and revised in 1985. In Turkey, the 74-item version was first used by Siva (1991) by adding culturally appropriate items. The Cronbach alpha validity of the scale is .88. The scale aims to evaluate the cognitive and behavioral coping processes used by individuals after a stressful life event. The scale consists of 8 subscales: problem-focused, seeking social support, keeping a distance, delusions, self-isolation, self-blame, positivity, and stress reduction. Scale questions are rated with a four-point measurement as (0) never (3) always. Karancı et al. (1999) used this scale in their study with Dinar earthquake survivors and shortened the scale to 42 items. A total of 32 questions were removed from the scale to create a new form with 42 items, and the quadruple measurement was replaced by a triple measurement of "(0) never, (1) sometimes, (2) always". Cronbach's alpha value was found to be .76

  "through study completion, an average of 1 year"

Study Arms (2)

motivational interviewing

EXPERIMENTAL

intervention group that received motivational interviewing intervention

Behavioral: Motivational interviewing

Control

NO INTERVENTION

No intervention will be applied to the control group.

Interventions

Motivational interviewing BEHAVIORAL

It is emphasized that motivational interviewing is a feasible intervention that can be used by various health professionals to optimize clinical outcomes in cancer patients and survivors, helping individuals to better cope with the stress they experience related to cancer and improve their quality of life. Considering the benefits of motivational interviewing on individuals diagnosed with cancer, it is anticipated that the intervention planned in the study will improve coping strategies, reduce post-traumatic stress symptoms, and increase the level of post-traumatic growth in women with endometrial cancer.

motivational interviewing

Eligibility Criteria

• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a native Turkish speaker and have no communication barriers
• Have been diagnosed with endometrial cancer
• Not be in the process of active treatment (chemotherapy, radiotherapy, hormone therapy, etc.)
• Be willing to participate in the study
• Have digital literacy.

You may not qualify if:

• Not having mental capacity/Having a psychotic disorder
• Being in the process of active treatment (chemotherapy, radiotherapy, hormone therapy, etc.)

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Merve Kochan Aksoy, PhD Candidate

CONTACT

+90 536 766 5127; kochanmerve4@gmail.com

Kamile Kabukcuoglu, Professor

CONTACT

+90 505 797 0464; kkamile@akdeniz.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant in Akdeniz University

Model Details: There are two groups with parallel characteristics. The first group is the intervention group, which will be given motivational interviews. The second group is the control group without intervention.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 17, 2025
• Study Start: February 3, 2025
• Primary Completion: August 4, 2025
• Study Completion: December 31, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)