The Effect of Logotherapy on Mental Health in Gynecological Cancer Patients

NCT ID: NCT05246462

Last Updated: 2022-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-25

Study Completion Date

2019-12-15

Brief Summary

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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

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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).

Conditions

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Cancer of Ovary Endometrium Cancer Cervix Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was conducted between 25 March-15 December 2019 as a single-blind randomized controlled trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants were blinded to treatment allocation. The investigator delivered the intervention and, therefore, could not be blinded to allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

Logotherapy

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Logotherapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gynecological cancer patients in a chemotherapy unit in Trabzon were recruited 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Ruveyde AYDIN

Akdeniz University Health Sciences Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akdeniz University Health Sciences Institute

Role: PRINCIPAL_INVESTIGATOR

Akdeniz University Health Sciences Institute

Locations

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Karadeniz Technical University

Trabzon, Turkey (+90), Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 37642347 (View on PubMed)

Other Identifiers

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Ruveyde AYDIN

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019/48)

Identifier Type: -

Identifier Source: org_study_id

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