NCT05129059

Brief Summary

The purpose of this study is to evaluate the effectiveness of logotherapy counseling program on chronic sorrow, meaning of life and dignity of palliative care patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 19, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

November 10, 2021

Last Update Submit

February 6, 2023

Conditions

Palliative CareCancer

Keywords

logotherapynursingmeaning in lifechronic sorrowdignity

Outcome Measures

Primary Outcomes (3)

  • meaning in life

    Meaning in life scale is a validated, 7-points Likert type scale with 2 dimensions. Possible scores range from 5 to 35 for each dimensions. Change= score of present meaning subscale\> searched meaning subscale (8 week subscale-baseline subscale

    baseline and 8 weeks

  • dignity

    The Patient Dignity Inventory is a valid, 5-points Likert type scale with 5 dimensions. Possible scores range from 25-125. Change= Lower score from the patient dignity inventory at the end of intervention compared to baseline.

    baseline and 8 weeks

  • chronic sorrow

    Prolonged grief disorder scale-patient form is a valid, 5-points Likert type scale. Possible scores range from 12 to 60. Change= Lower score from the scale at the end of intervention compared to baseline.

    baseline and 8 weeks

Study Arms (2)

Logotherapy

EXPERIMENTAL

Participants will receive individual logotherapy counseling by the investigator for 8 visits in 4 weeks.

Other: Logotherapy

Control

NO INTERVENTION

Participants will receive routine care.

Interventions

LogotherapyOTHER

Logotherapy is a method of finding meaning with three basic principles. The first principle is that life is meaningful in every situation , even in the most desperate moments. The second principle is that the main source of motivation is the desire to find meaning in life. The third is that an individual is free to choose his own attitude even in the worst conditions.

Logotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalized patients due to advanced cancer Patients informed of cancer diagnosis at least 1 month Patients reporting to have chronic sorrow Patients with palliative performance scale score at least 50% Patients having life expectancy more than 6 months Patients who volunteered to participate in the study and signed written informed consent

You may not qualify if:

  • Clinically diagnosed mental disorder Patients with palliative performance scale score \< 40%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Hospital

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Eskigulek Y, Kav S. Effect of logotherapy counseling program on chronic sorrow, dignity, and meaning in life of palliative care patients: a randomized controlled trial. Support Care Cancer. 2024 Aug 13;32(9):587. doi: 10.1007/s00520-024-08792-w.

    PMID: 39138762DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Logotherapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Yasemin Eskigülek

    Baskent University

    PRINCIPAL INVESTIGATOR

  • Sultan Kav

    Baskent University

    STUDY DIRECTOR

Central Study Contacts

Yasemin Eskigülek

CONTACT

+905447887405yaseminuslu12@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, MSN

Study Record Dates

First Submitted

November 10, 2021

First Posted

November 22, 2021

Study Start

January 19, 2021

Primary Completion

April 1, 2023

Study Completion

May 31, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)