End of Life PatientsNCT07150728
The Effectiveness of Dignity Therapy in Terminal Ill Patients
A study testing dignity therapy and Hospice palliative care in people with End of Life Patients, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End of Life Patients
- What is being tested?
- dignity therapy and Hospice palliative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Sep 2023to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Those diagnosed by a physician with dementia, delirium, or other organic brain disease.
- Those who are unconscious and incapable of acting.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- End of Life Patients
- Being tested
- dignity therapy, Hospice palliative care
- Keywords
- End of life patients, dignity therapy, dignity, demoralization, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dignity therapyBehavioural
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.
Hospice palliative careBehavioural
Participants regularly receive hospice care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: dignity therapy |
| Hospice palliative care | Placebo comparator | Participants routinely performed hospice palliative care Receives: Behavioral: Hospice palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Dignity Inventory Mandarin Version (PDI-MV)
Measured: Before dignity therapy, immediately after intervention, 1 month, 3 months
Demoralization Scale-Mandarin Version (DS-MV)
Measured: Before dignity therapy, immediately after intervention, 1st month, 3rd month
Patient Health Questionnaire-9 (PHQ-9)
Measured: Before dignity therapy, immediately after intervention, 1st month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start14 Sep 2023
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End of Life PatientsStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150728
- Sponsor's protocol ID
- KMUHIRB-F(I)-20220202
- Status last verified
- Dec 2022
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dignity Therapy in Terminal Ill Patients
- ClinicalTrials.gov ID
- NCT07150728
- Acronym / sponsor ID
- KMUHIRB-F(I)-20220202
- Conditions
- End of Life Patients
- Keywords
- End of life patients, dignity therapy, dignity, demoralization, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Taiwan
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dignity therapy | Experimental | Behavioral: dignity therapyDignity 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. |
| Hospice palliative care | Placebo comparator | Behavioral: Hospice palliative careParticipants routinely performed hospice palliative care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Those diagnosed by a physician with dementia, delirium, or other organic brain disease.
- Those who are unconscious and incapable of acting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dignity therapyDignity 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. | Behavioural | dignity therapy |
| Hospice palliative careParticipants regularly receive hospice care | Behavioural | Hospice palliative care |
Primary outcome
Patient Dignity Inventory Mandarin Version (PDI-MV)
Time frame: Before dignity therapy, immediately after intervention, 1 month, 3 months
Demoralization Scale-Mandarin Version (DS-MV)
Time frame: Before dignity therapy, immediately after intervention, 1st month, 3rd month
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Before dignity therapy, immediately after intervention, 1st month, 3rd month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dignity therapy and Hospice palliative care in people with End of Life Patients, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Dignity Inventory Mandarin Version (PDI-MV) (time frame: Before dignity therapy, immediately after intervention, 1 month, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.