NCT07150728

Brief Summary

Maintaining patient dignity is the moral obligation and an important ethical consideration of health professionals; it is also the primary connotation of medical care. Previous research revealed that terminal patients had moderate to severe dignity loss, and approximately 40% of them suffered from dignity-related distress, which required assistance from health professionals. This is a second- and third-year study project. The first-year study established and developed the localized "Terminal Patient Dignity Model" and "Terminal Patient Dignity Scale" for Taiwan. At present, the reliability and validity of the scale are being continuously tested. The second-year study adopts a longitudinal study design. The dignity therapy is referred for intervention. It adopts the randomized controlled experimental study method. Patients with terminal illness in a medical center will be randomly assigned to two groups, and each group is expected to have 34 patients. The experimental group will be provided with dignity therapy, whereas hospice palliative care will be adopted for the control group. Dignity, demoralization, depression, and other indicators will be measured in the pretest, immediately after the intervention, at 1 month and 3 months. In the third year, the study project will continue the intervention scheme and track the results of dignity, demoralization, depression, and other indicators at 6 and 9 months after the intervention. This study can help understand the status of dignity among terminal patients in Taiwan, and extend the terminal patient dignity scale and dignity therapy to noncancer terminal patients, in order to provide appropriate care to maintain dignity. It is also expected to provide a reference for the government to formulate empirical care policies on dignity therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration 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

September 14, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2025

Completed
Last Updated

September 2, 2025

Status Verified

December 1, 2022

Enrollment Period

1.9 years

First QC Date

August 25, 2025

Last Update Submit

August 25, 2025

Conditions

Keywords

End of life patients, dignity therapy, dignity, demoralization, depression

Outcome Measures

Primary Outcomes (3)

  • Patient Dignity Inventory Mandarin Version (PDI-MV)

    Before dignity therapy, immediately after intervention, 1 month, 3 months

  • Demoralization Scale-Mandarin Version (DS-MV)

    Before dignity therapy, immediately after intervention, 1st month, 3rd month

  • Patient Health Questionnaire-9 (PHQ-9)

    Before dignity therapy, immediately after intervention, 1st month, 3rd month

Study Arms (2)

dignity therapy

EXPERIMENTAL

Dignity therapists use the "Dignity Psychotherapy Question Protocol" to guide patients through life's most important issues, providing them with the opportunity to participate in and discuss the things they would like their families to remember them for. During the process, dignity therapists use audio recording to fully record, transcribe, and edit the interview material, creating a valuable record that the patient wishes to preserve. The edited document is then returned to the patient, who then gives it to their family members.

Behavioral: dignity therapy

Hospice palliative care

PLACEBO COMPARATOR

Participants routinely performed hospice palliative care

Behavioral: Hospice palliative care

Interventions

dignity therapyBEHAVIORAL

Dignity therapists use the "Dignity Psychotherapy Question Protocol" to guide patients through life's most important issues, providing them with the opportunity to participate in and discuss the things they would like their families to remember them for. During the process, dignity therapists use audio recording to fully record, transcribe, and edit the interview material, creating a valuable record that the patient wishes to preserve. The edited document is then returned to the patient, who then gives it to their family members.

dignity therapy

Participants regularly receive hospice care

Hospice palliative care

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with a terminal illness by their attending physician, whose disease has progressed to the point where death is inevitable, and who are receiving palliative care such as hospice care, hospice home care, or hospice co-care.
  • Patients aged 20 or above.
  • Patients who can communicate in Mandarin or Taiwanese.
  • Patients who are willing to participate in this research project and complete the consent form after the purpose and process of the research are explained.

You may not qualify if:

  • Those diagnosed by a physician with dementia, delirium, or other organic brain disease.
  • Those who are unconscious and incapable of acting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Depression

Interventions

Dignity TherapyHospice and Palliative Care Nursing

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesNursing CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 2, 2025

Study Start

September 14, 2023

Primary Completion

August 25, 2025

Study Completion

August 25, 2025

Last Updated

September 2, 2025

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations