- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05246462
The Effect of Logotherapy on Mental Health in Gynecological Cancer Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Turkey (+90)
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Trabzon, Turkey (+90), Turkey, 6100
- Karadeniz Technical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
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.
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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.
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Traumatic Stress Symptoms Scale (TSSS)
Time Frame: It varies between 7-14 weeks.
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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
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It varies between 7-14 weeks.
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Post-Traumatic Growth Inventory (PTGI)
Time Frame: It varies between 7-14 weeks.
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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.
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It varies between 7-14 weeks.
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Meaning in Life Questionnaire (MLQ)
Time Frame: It varies between 7-14 weeks.
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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.
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It varies between 7-14 weeks.
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Spiritual Well-Being Scale (SWBS)
Time Frame: It varies between 7-14 weeks.
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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.
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It varies between 7-14 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Akdeniz University Health Sciences Institute, Akdeniz University Health Sciences Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Uterine Cervical Neoplasms
- Ovarian Neoplasms
- Endometrial Neoplasms
Other Study ID Numbers
- 2019/48)
- Ruveyde AYDIN (Registry Identifier: Ruveyde AYDIN)
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
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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