NCT05246462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

January 12, 2022

Last Update Submit

February 8, 2022

Conditions

Cancer of OvaryEndometrium CancerCervix Cancer

Keywords

gynecological cancerspost-traumatic growththe meaning of lifenursinglogotherapy

Outcome Measures

Primary Outcomes (4)

  • 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

    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.

    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.

    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.

    It varies between 7-14 weeks.

Study Arms (2)

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.

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Turkey (+90), 6100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 37642347DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsUterine Cervical Neoplasms

Interventions

Logotherapy

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine DiseasesUterine Cervical Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Akdeniz University Health Sciences Institute

    Akdeniz University Health Sciences Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to treatment allocation. The investigator delivered the intervention and, therefore, could not be blinded to allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was conducted between 25 March-15 December 2019 as a single-blind randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Akdeniz University Health Sciences Institute

Study Record Dates

First Submitted

January 12, 2022

First Posted

February 18, 2022

Study Start

March 25, 2019

Primary Completion

November 10, 2019

Study Completion

December 15, 2019

Last Updated

February 18, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)