- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06781216
Effect of Motivational Interviewing on Posttraumatic Stress Symptoms and Posttraumatic Growth in Women with Endometrial Cancer
Effect of Motivational Interviewing on Posttraumatic Stress Symptoms and Posttraumatic Growth in Women with Endometrial Cancer: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
The incidence of endometrial cancer has increased in recent years, posing a serious threat to women's health, and tends to develop at a younger age. Following endometrial cancer treatment, women traditionally have regular follow-up appointments at hospital outpatient clinics to detect recurrence at an early stage, thus improving survival and support. The transition from cancer diagnosis and treatment to a long-term, rigorous surveillance protocol is a significant source of stress for individuals. Evidence suggests that endometrial cancer survivors have long-term physical, psychological, and social needs that are not met through traditional hospital-based follow-up. Previous studies have shown that the prevalence of anxiety, depression, and psychological distress in women with endometrial cancer is as high as 43.7%, 43.9%, and 54%, respectively.
Providing holistic well-being for women with endometrial cancer requires comprehensive medical, psychological, and social support throughout the course of diagnosis. As with all cancers, women with endometrial cancer who transition from primary acute treatment to follow-up survivorship face a number of significant challenges in regaining and maintaining their health and well-being. Many lack knowledge about the risk of recurrence, long-term late side effects, and how to manage them. A study of women with endometrial cancer in Australia found that women's long-term unmet needs were largely related to their psychosocial well-being, requiring assistance to cope with the expectations of themselves or others several years after their diagnosis.
When cancer becomes a part of life, individuals may experience symptoms of post-traumatic stress and even post-traumatic stress disorder. The coping mechanisms an individual uses significantly affect both psychosocial adjustment to a cancer diagnosis and play a significant role in PTG. The use of maladaptive coping strategies has also been reported to be associated with higher levels of perceived stress.
Recognizing the role of psychosocial factors in contributing to poor health outcomes and understanding individuals' coping experiences, health beliefs, and motivational factors will help design effective interventions. It is stated that motivational interviewing may be important for individuals struggling with the physical and emotional difficulties of cancer treatment or survivorship. A systematic review and meta-analysis reported that motivational interviewing has a positive effect on various health outcomes including depression and self-efficacy in the cancer population. In addition, considering the obstacles and health difficulties that these individuals face as a result of diagnosis and treatment, the study emphasizes that motivational interviewing is a feasible intervention that can be used by various health professionals to optimize clinical outcomes in cancer patients and survivors, and helps individuals 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 predicted that the intervention planned in the study will improve coping strategies in women with endometrial cancer, reduce post-traumatic stress symptoms and increase the level of post-traumatic growth.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merve Kochan Aksoy, PhD Candidate
- Phone Number: +90 536 766 5127
- Email: kochanmerve4@gmail.com
Study Contact Backup
- Name: Kamile Kabukcuoglu, Professor
- Phone Number: +90 505 797 0464
- Email: kkamile@akdeniz.edu.tr
Study Locations
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Antalya, Turkey, 07070
- Akdeniz University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not having mental capacity/Having a psychotic disorder
- Being in the process of active treatment (chemotherapy, radiotherapy, hormone therapy, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
No intervention will be applied to the control group.
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Experimental: motivational interviewing
intervention group that received motivational interviewing intervention
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-Traumatic Stress Disorder Checklist Scale for DSM-5
Time Frame: * "through study completion, an average of 1 year"
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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.
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* "through study completion, an average of 1 year"
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Post-Traumatic Growth Scale
Time Frame: "through study completion, an average of 1 year"
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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.
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"through study completion, an average of 1 year"
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Ways of Coping Scale
Time Frame: "through study completion, an average of 1 year"
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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
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"through study completion, an average of 1 year"
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AkdenizzUniversityy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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