Clinical trial NCT05246462: The Effect of Logotherapy on Mental Health in Gynecological Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Ovary
Endometrium Cancer
Cervix Cancer
Keywords: gynecological cancers
post-traumatic growth
the meaning of life
nursing
logotherapy
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was conducted between 25 March-15 December 2019 as a single-blind randomized controlled trial.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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

1. 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).
2. 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).
3. 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).
4. 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Traumatic Stress Symptoms Scale (TSSS)
timeFrame: It varies between 7-14 weeks.
measure: Post-Traumatic Growth Inventory (PTGI)
timeFrame: It varies between 7-14 weeks.
measure: Meaning in Life Questionnaire (MLQ)
timeFrame: It varies between 7-14 weeks.
measure: Spiritual Well-Being Scale (SWBS)
timeFrame: It varies between 7-14 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
state: Turkey (+90)
Study officials:
affiliation: Akdeniz University Health Sciences Institute
name: Akdeniz University Health Sciences Institute
role: PRINCIPAL_INVESTIGATOR
References: