NCT06105359

Brief Summary

The aim of this study is to determine the effect of dignity therapy on the quality of life and depression levels of cancer patients. Methods: The research was planned as a randomized controlled experimental study. Type of Research: Research, experimental, control group and pretest-posttest study will be carried out. Population of the Study: The population of the study was sent to Meram Medical Faculty Hospital Oncology Clinic consists of male and female inpatients. Sample of the Research: Those who agreed to participate in the research and met the inclusion criteria. Patients who meet will be included in the study. It was 48. It was planned to be. Randomization: In this study, parallel group block randomization method was applied to the intervention and control groups. will be allocated randomly. Block randomization was used because the sample size was small. Patients will be selected equally using permutation method, and randomization will be selected using blocking technique. will be done. During randomization, CONSORT 2017 will be used. For randomization; To control for performance bias, patients will be blinded to the study hypothesis and will not be informed which group they are in. There will be no blinding for the researcher. However, blind technique will be used in the research. This blind technique will be applied by the researcher with the patients blinded until the application begins.. Data Collection Techniques and Tools: "Personal Information Form", "Patient Dignity Inventory" and "Rosenberg Self-Esteem Scale" were used in data collection (RSES)" will be used.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable cancer

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

January 12, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

October 18, 2023

Last Update Submit

April 6, 2026

Conditions

Keywords

Dignity therapycancer patientdepression

Outcome Measures

Primary Outcomes (1)

  • Patient Dignity Inventory

    The scale, consisting of a total of 25 items, was developed by Chochinov et al. (2008) and translated into Turkish by Eskigülek and Kav (2022) adapted. The minimum and maximum total score of the inventory is 25 and 125 points respectively. There are no reverse scored items in the inventory. A higher total score means that the individual's perceived reputation is complex. Items scoring three or more are clinically significant. As a result of factor analysis, a five-factor structure was obtained; The factors are reported as "symptom distress", "existential distress", "addiction", "peace of mind" and "social support"

    Baseline (Day 0) and Day 10

Secondary Outcomes (2)

  • Personal Information Form

    Baseline (Day 0) and Day 10

  • Rosenberg Self-Esteem Scale

    Baseline (Day 0) and Day 10

Study Arms (2)

experimental group

EXPERIMENTAL

Patients in this group will be treated with dignity therapy by the researcher.

Behavioral: Dignity therapy

control group

ACTIVE COMPARATOR

Patients in this group will receive standard care and no treatment will be performed by the researcher.

Other: Routine Care

Interventions

The control group will receive routine clinical care as provided by the oncology clinic. No additional psychological or supportive intervention will be administered by the researchers to this group during the study period.

control group
Dignity therapyBEHAVIORAL

Dignity therapy will be applied in the interview room that will be requested in the oncology clinic to protect the confidentiality of information. The application is planned as five sessions and the sessions will last approximately 40 minutes. Two questions in the dignity therapy protocol will be discussed in each session.

experimental group

Eligibility Criteria

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

You may qualify if:

  • Able to speak and understand Turkish,
  • Those over 18 years of age
  • No communication barriers
  • Cancer diagnosis is in the 4th stage and in the last stage
  • Patients with a predicted survival time of less than 6 months (physician opinion) will be included

You may not qualify if:

  • Those diagnosed with dementia, delirium or other organic brain disorders;
  • Those with impaired consciousness;
  • Patients with mental problems that prevent them from receiving esteem therapy will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan Üniversitesi

Konya, 42080, Turkey (Türkiye)

Location

Related Publications (1)

  • Chochinov HM. Dignity-conserving care--a new model for palliative care: helping the patient feel valued. JAMA. 2002 May 1;287(17):2253-60. doi: 10.1001/jama.287.17.2253.

MeSH Terms

Conditions

NeoplasmsDepression

Interventions

Dignity Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • NESIBE GÜNAY MOLU

    Necmettin Erbakan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
To control for performance bias, patients will be blinded to the study hypothesis and will not be informed which group they are in. There will be no blinding for the researcher. However, blind technique will be used in the research. This blind technique will be applied by the researcher with the patients blinded until the application begins. In the research, in order to meet the blind technical conditions, the process steps were carried out by an independent statistician from the first stage. The sample will be sorted by a combination order and number. In this way selection bias will be controlled. The study will also be controlled for attrition bias and Statistics and reporting bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Research, experimental control group and pretest-posttest study will be carried out.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 27, 2023

Study Start

January 12, 2023

Primary Completion

September 15, 2025

Study Completion

September 15, 2025

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data will not be shared due to protection of patient confidentiality and institutional rules.

Locations