Cancer of OvaryNCT05246462
The Effect of Logotherapy on Mental Health in Gynecological Cancer Patients
A study testing Logotherapy in people with Cancer of Ovary and Endometrium Cancer, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Gynecological cancers negatively affect women's sexuality, fertility, body image, and self-perception, resulting in deterioration in their psychological health. The aim of this study is to examine the effects of logotherapy on traumatic stress symptoms, post-traumatic growth, finding meaning in life, and spiritual… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer of Ovary, Endometrium Cancer, Cervix Cancer
- What is being tested?
- Logotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2019to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gynecological cancer patients in a chemotherapy unit in Trabzon were recruited in the study
- Inclusion criteria for the study were volunteering to take part in the study
- Being able to read and write in Turkish
- Being 18 years of age or older
- Having been diagnosed with gynecological cancer
- Knowing that s/he had been diagnosed with cancer
- Having received at least one chemotherapy treatment and having cancer stage 2 or 3.
Who cannot join
- Exclusion criteria in the study were having a verbal communication disability
- Having been diagnosed with psychotic and neurological disorders
- Having received, or receiving psychotherapy, living outside the city center of Trabzon
- Receiving treatment at intervals longer than 21 days.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karadeniz Technical University
Trabzon, Turkey (+90), 6100
About this study
Official title: The Effect of Logotherapy on Traumatic Stress Symptom, Post-Traumatic Growth, Finding Meaning in Life, and Spiritual Well-Being in Gynecological Cancer Patients: A Randomized Control Study
Gynecological cancers negatively affect women's sexuality, fertility, body image, and self-perception, resulting in deterioration in their psychological health. The aim of this study is to examine the effects of logotherapy on traumatic stress symptoms, post-traumatic growth, finding meaning in life, and spiritual well-being in gynecological cancer patients. No research has yet been found that examines logotherapy's symptoms of post-traumatic stress, post-traumatic growth, the meaning of life, and the spiritual well-being of gynecological cancer patients. The study was conducted in a single-blind randomized controlled trial with 68 women with gynecological cancer. The study is registered at ClinicalTrials.gov NCT… While logotherapy interviews including seven sessions were made in the experimental group, only routine nursing care was given to the control group. The data were collected using the Personal Information Form (PIF), the Traumatic Stress Symptom Scale (TSSS), the Post-Traumatic Growth Inventory (PTGI), the Meaning in Life Questionnaire (MLQ), and the Spiritual Well-Being Scale (SWBS). To analyze the data, descriptive statistics and parametric-nonparametric tests were used in the analysis of the data.
Read the detailed description
Cancer exposes the individual to challenging situations like lack of knowledge about the treatment process, low/absence of social support, economic difficulties, fear of losing health, changes in roles in society and family, and fear of death. In addition to these situations encountered in all types of cancer, gynecological cancers also negatively affect women's sexuality, fertility, menopause symptoms, and self-perception, leading to the deterioration of their psychological health. The absence of supportive care against these cancer-induced adverse conditions causes stress, anxiety, depression, post-traumatic stress disorder (PTSD), and existential emptiness in patients.
Studies conducted with women with gynecological cancer have shown that the frequency of women experiencing PTSD varies between 9.25% and 70%, and women experience at least two of the symptoms of PTSD. Cancer patients report that they feel lonely, they can hardly control their anger, they are disappointed, they feel unhappy and meaningless. Studies focusing on the experiences of cancer patients have revealed that nearly half of the patients experience meaninglessness and hopelessness. Therefore, it is the primary responsibility of health professionals/nurses to accompany and contribute to the journey of cancer patients to find meaning.
Research Hypotheses
- The total mean TSSS score of the women in the experimental group who participated in the logotherapy interviews was lower than that of the women in the control group (H1).
- The total mean PTGI score of the women in the experimental group who participated in the logotherapy interviews was higher than that of the women in the control group (H1).
- The total mean MLQ score of the women in the experimental group who participated in the logotherapy interviews was higher than that of the women in the control group (H1).
- The total mean SWBS score of the women in the experimental group who participated in the logotherapy interviews was higher than that of the women in the control group (H1).
- Conditions
- Cancer of Ovary, Endometrium Cancer, Cervix Cancer
- Being tested
- Logotherapy
- Keywords
- gynecological cancers, post-traumatic growth, the meaning of life, nursing, logotherapy
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LogotherapyOther
In this study, the experimental group received seven-session logotherapy-based interviews on making sense of life, while the control group received only routine nursing care. In this study, Personal Meaning Oriented Psychotherapy (PMOP) was used to structure interviews on making sense of life based on Logotherapy and enhance the sense of meaning in cancer patients, share their concerns, experiences, and feelings about diagnosis-treatment, have their difficulties defined, maintain, and develop their sense of purpose and responsibility.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Gynecological cancer patients in a chemotherapy unit in Trabzon were recruited in the study. Inclusion criteria for the study were volunteering to take part in the study, being able to read and write in Turkish, being 18 years of age or older, having been diagnosed with gynecological cancer, knowing that s/he had been diagnosed with cancer, having received at least one chemotherapy treatment and having cancer stage 2 or 3. Exclusion criteria in the study were having a verbal communication disability, having been diagnosed with psychotic and neurological disorders, having received, or receiving psychotherapy, living outside the city center of Trabzon, and receiving treatment at intervals longer than 21 days. The experimental group received 7 sessions of logotherapy interviews. Receives: Other: Logotherapy |
| Control group | No intervention | Gynecological cancer patients in a chemotherapy unit in Trabzon were recruited in the study. Inclusion criteria for the study were volunteering to take part in the study, being able to read and write in Turkish, being 18 years of age or older, having been diagnosed with gynecological cancer, knowing that s/he had been diagnosed with cancer, having received at least one chemotherapy treatment and having cancer stage 2 or 3. Exclusion criteria in the study were having a verbal communication disability, having been diagnosed with psychotic and neurological disorders, having received, or receiving psychotherapy, living outside the city center of Trabzon, and receiving treatment at intervals longer than 21 days. The control group received standard nursing care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traumatic Stress Symptoms Scale (TSSS)
TSSS is a 4-point Likert scale (0=not disturbing at all, 3=very disturbing) and consists of 23 items. The scale includes two sub-dimensions: post-traumatic stress disorder (PTSD) and depression. The lowest score to be obtained from the scale is 0 and the highest score is 69. The total Cronbach's alpha of the scale is 0.94
Measured: It varies between 7-14 weeks.
Post-Traumatic Growth Inventory (PTGI)
The scale consists of 23 items and 5 factors such as spiritual and existential change, change in perception of life and selfness, relating to others, new possibilities, and personal strength. Scoring of the Likert-type scale varies between 0 (never experienced) and 5 (experienced a lot). The lowest score to be taken from the scale is 0, and the highest score is 115. The total Cronbach's alpha of the scale is 0.93.
Measured: It varies between 7-14 weeks.
Meaning in Life Questionnaire (MLQ)
The scale consists of 10 items in total on the scale, and the 9th item is reverse coded. The scale consists of two factors: the presence of meaning and the search for meaning. The scale is scored as a 7-point Likert type (1: not true at all; 7: absolutely true). The lowest and the highest score to be obtained from the scale are 10 and the highest score is 70. The overall Cronbach alpha of the scale is 0.86.
Measured: It varies between 7-14 weeks.
Spiritual Well-Being Scale (SWBS)
The scale consists of 29 items and three sub-dimensions: transcendence, nature harmony, and anomie. The scale is a 5-point Likert type (1: not suitable for me at all, 5: completely suitable for me). The lowest and highest scores to be obtained from the scale are 29 and 145. The total Cronbach alpha of the scale is 0.88.
Measured: It varies between 7-14 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start25 Mar 2019
- Primary completion10 Nov 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of OvaryStudies 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
- This study was conducted between 25 March-15 December 2019 as a single-blind randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruveyde AYDIN, Akdeniz University
- Investigators
- Akdeniz University Health Sciences Institute, Principal investigator, Akdeniz University Health Sciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246462
- Sponsor's protocol ID
- 2019/48)
- Other IDs
- Ruveyde AYDIN
- Status last verified
- Feb 2022
- First submitted
- 12 Jan 2022
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aydin R, Kabukcuoglu K. The effect of logotherapy-based, nurse-guided meaning attribution conversations on women diagnosed with gynecologic cancer: A Turkish pilot study. Women Health. 2023 Sep 14;63(8):599-614. doi: 10.1080/03630242.2023.2249123. Epub 2023 Aug 29.
PubMed 37642347
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Logotherapy on Traumatic Stress Symptom, Post-Traumatic Growth, Finding Meaning in Life, and Spiritual Well-Being in Gynecological Cancer Patients: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT05246462
- Acronym / sponsor ID
- 2019/48)
- Conditions
- Cancer of Ovary, Endometrium Cancer, Cervix Cancer
- Keywords
- gynecological cancers, post-traumatic growth, the meaning of life, nursing, logotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 18 Feb 2022 (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.
Gynecological cancers negatively affect women's sexuality, fertility, body image, and self-perception, resulting in deterioration in their psychological health. The aim of this study is to examine the effects of logotherapy on traumatic stress symptoms, post-traumatic growth, finding meaning in life, and spiritual well-being in gynecological cancer patients. No research has yet been found that examines logotherapy's symptoms of post-traumatic stress, post-traumatic growth, the meaning of life, and the spiritual well-being of gynecological cancer patients. The study was conducted in a single-blind randomized controlled trial with 68 women with gynecological cancer. The study is registered at ClinicalTrials.gov NCT… While logotherapy interviews including seven sessions were made in the experimental group, only routine nursing care was given to the control group. The data were collected using the Personal Information Form (PIF), the Traumatic Stress Symptom Scale (TSSS), the Post-Traumatic Growth Inventory (PTGI), the Meaning in Life Questionnaire (MLQ), and the Spiritual Well-Being Scale (SWBS). To analyze the data, descriptive statistics and parametric-nonparametric tests were used in the analysis of the data.
Detailed description
Cancer exposes the individual to challenging situations like lack of knowledge about the treatment process, low/absence of social support, economic difficulties, fear of losing health, changes in roles in society and family, and fear of death. In addition to these situations encountered in all types of cancer, gynecological cancers also negatively affect women's sexuality, fertility, menopause symptoms, and self-perception, leading to the deterioration of their psychological health. The absence of supportive care against these cancer-induced adverse conditions causes stress, anxiety, depression, post-traumatic stress disorder (PTSD), and existential emptiness in patients.
Studies conducted with women with gynecological cancer have shown that the frequency of women experiencing PTSD varies between 9.25% and 70%, and women experience at least two of the symptoms of PTSD. Cancer patients report that they feel lonely, they can hardly control their anger, they are disappointed, they feel unhappy and meaningless. Studies focusing on the experiences of cancer patients have revealed that nearly half of the patients experience meaninglessness and hopelessness. Therefore, it is the primary responsibility of health professionals/nurses to accompany and contribute to the journey of cancer patients to find meaning.
Research Hypotheses
- The total mean TSSS score of the women in the experimental group who participated in the logotherapy interviews was lower than that of the women in the control group (H1).
- The total mean PTGI score of the women in the experimental group who participated in the logotherapy interviews was higher than that of the women in the control group (H1).
- The total mean MLQ score of the women in the experimental group who participated in the logotherapy interviews was higher than that of the women in the control group (H1).
- The total mean SWBS score of the women in the experimental group who participated in the logotherapy interviews was higher than that of the women in the control group (H1).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was conducted between 25 March-15 December 2019 as a single-blind randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: LogotherapyGynecological cancer patients in a chemotherapy unit in Trabzon were recruited in the study. Inclusion criteria for the study were volunteering to take part in the study, being able to read and write in Turkish, being 18 years of age or older, having been diagnosed with gynecological cancer, knowing that s/he had been diagnosed with cancer, having received at least one chemotherapy treatment and having cancer stage 2 or 3. Exclusion criteria in the study were having a verbal communication disability, having been diagnosed with psychotic and neurological disorders, having received, or receiving psychotherapy, living outside the city center of Trabzon, and receiving treatment at intervals longer than 21 days. The experimental group received 7 sessions of logotherapy interviews. |
| Control group | No intervention | –Gynecological cancer patients in a chemotherapy unit in Trabzon were recruited in the study. Inclusion criteria for the study were volunteering to take part in the study, being able to read and write in Turkish, being 18 years of age or older, having been diagnosed with gynecological cancer, knowing that s/he had been diagnosed with cancer, having received at least one chemotherapy treatment and having cancer stage 2 or 3. Exclusion criteria in the study were having a verbal communication disability, having been diagnosed with psychotic and neurological disorders, having received, or receiving psychotherapy, living outside the city center of Trabzon, and receiving treatment at intervals longer than 21 days. The control group received standard nursing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gynecological cancer patients in a chemotherapy unit in Trabzon were recruited in the study
- Inclusion criteria for the study were volunteering to take part in the study
- Being able to read and write in Turkish
- Being 18 years of age or older
- Having been diagnosed with gynecological cancer
Key exclusion criteria (4 listed)
- Exclusion criteria in the study were having a verbal communication disability
- Having been diagnosed with psychotic and neurological disorders
- Having received, or receiving psychotherapy, living outside the city center of Trabzon
- Receiving treatment at intervals longer than 21 days.
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 |
|---|---|---|
| LogotherapyIn this study, the experimental group received seven-session logotherapy-based interviews on making sense of life, while the control group received only routine nursing care. In this study, Personal Meaning Oriented Psychotherapy (PMOP) was used to structure interviews on making sense of life based on Logotherapy and enhance the sense of meaning in cancer patients, share their concerns, experiences, and feelings about diagnosis-treatment, have their difficulties defined, maintain, and develop their sense of purpose and responsibility. | Other | Experimental group |
Primary outcome
Traumatic Stress Symptoms Scale (TSSS)
Time frame: It varies between 7-14 weeks.
TSSS is a 4-point Likert scale (0=not disturbing at all, 3=very disturbing) and consists of 23 items. The scale includes two sub-dimensions: post-traumatic stress disorder (PTSD) and depression. The lowest score to be obtained from the scale is 0 and the highest score is 69. The total Cronbach's alpha of the scale is 0.94
Post-Traumatic Growth Inventory (PTGI)
Time frame: It varies between 7-14 weeks.
The scale consists of 23 items and 5 factors such as spiritual and existential change, change in perception of life and selfness, relating to others, new possibilities, and personal strength. Scoring of the Likert-type scale varies between 0 (never experienced) and 5 (experienced a lot). The lowest score to be taken from the scale is 0, and the highest score is 115. The total Cronbach's alpha of the scale is 0.93.
Meaning in Life Questionnaire (MLQ)
Time frame: It varies between 7-14 weeks.
The scale consists of 10 items in total on the scale, and the 9th item is reverse coded. The scale consists of two factors: the presence of meaning and the search for meaning. The scale is scored as a 7-point Likert type (1: not true at all; 7: absolutely true). The lowest and the highest score to be obtained from the scale are 10 and the highest score is 70. The overall Cronbach alpha of the scale is 0.86.
Spiritual Well-Being Scale (SWBS)
Time frame: It varies between 7-14 weeks.
The scale consists of 29 items and three sub-dimensions: transcendence, nature harmony, and anomie. The scale is a 5-point Likert type (1: not suitable for me at all, 5: completely suitable for me). The lowest and highest scores to be obtained from the scale are 29 and 145. The total Cronbach alpha of the scale is 0.88.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Derived from this study: PubMed 37642347Aydin R, Kabukcuoglu K. The effect of logotherapy-based, nurse-guided meaning attribution conversations on women diagnosed with gynecologic cancer: A Turkish pilot study. Women Health. 2023 Sep 14;63(8):599-614. doi: 10.1080/03630242.2023.2249123. Epub 2023 Aug 29.
- 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. This study is not recruiting at the moment.
Akdeniz University Health Sciences Institute principal investigator
Akdeniz University Health Sciences Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Logotherapy in people with Cancer of Ovary and Endometrium Cancer, 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 18 Feb 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traumatic Stress Symptoms Scale (TSSS) (time frame: It varies between 7-14 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05246462, which also lists 1 linked publication.
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 18 Feb 2022.