Endometrium CancerNCT06781216
Effect of Motivational Interviewing on Posttraumatic Stress Symptoms and Posttraumatic Growth in Women with Endometrial Cancer
A study testing Motivational interviewing in people with Endometrium Cancer and Post Traumatic Stress Symptoms, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrium Cancer, Post Traumatic Stress Symptoms, Post Traumatic Growth, Psychological
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not having mental capacity/Having a psychotic disorder
- Being in the process of active treatment (chemotherapy, radiotherapy, hormone therapy, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Motivational Interviewing on Posttraumatic Stress Symptoms and Posttraumatic Growth in Women with Endometrial Cancer: a Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Motivational interviewing
- Keywords
- Endometrium cancer, Motivational interviewing, Post traumatic growth, Post traumatic stress symptoms
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| motivational interviewing | Experimental | intervention group that received motivational interviewing intervention Receives: Behavioral: Motivational interviewing |
| Control | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: * "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.
Measured: "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
Measured: "through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start3 Feb 2025 (estimated)
- Primary completion4 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrium CancerStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Kochan Aksoy, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781216
- Sponsor's protocol ID
- AkdenizzUniversityy
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Motivational Interviewing on Posttraumatic Stress Symptoms and Posttraumatic Growth in Women with Endometrial Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06781216
- Acronym / sponsor ID
- AkdenizzUniversityy
- Keywords
- Endometrium cancer, Motivational interviewing, Post traumatic growth, Post traumatic stress symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (estimated)
- Primary completion
- 4 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| motivational interviewing | Experimental | Behavioral: Motivational interviewingintervention group that received motivational interviewing intervention |
| Control | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Not having mental capacity/Having a psychotic disorder
- Being in the process of active treatment (chemotherapy, radiotherapy, hormone therapy, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingIt 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. | Behavioural | motivational interviewing |
Primary outcome
Post-Traumatic Stress Disorder Checklist Scale for DSM-5
Time frame: * "through study completion, an average of 1 year"
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.
Post-Traumatic Growth Scale
Time frame: "through study completion, an average of 1 year"
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.
Ways of Coping Scale
Time frame: "through study completion, an average of 1 year"
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Endometrium Cancer and Post Traumatic Stress Symptoms, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merve Kochan Aksoy, PhD Candidate (+90 536 766 5127, kochanmerve4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Traumatic Stress Disorder Checklist Scale for DSM-5 (time frame: * "through study completion, an average of 1 year"). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.