Cultural acceptability and potential effectiveness of dignity therapy for patients with terminal cancer in Taiwan
| ISRCTN | ISRCTN99678415 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99678415 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | National Science and Technology Council |
| Funder | National Science and Technology Council |
- Submission date
- 05/11/2025
- Registration date
- 11/11/2025
- Last edited
- 19/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
This study explores how culturally acceptable and clinically effective dignity therapy (DT) is for people with terminal cancer in Taiwan. Dignity therapy helps patients reflect on their lives and share meaningful memories, which may reduce emotional distress. The research addresses a gap in evidence about how well this therapy works in East Asian settings.
Who can participate?
Participants include adults diagnosed with terminal cancer who are expected to live less than six months. They must be able to communicate clearly, complete questionnaires, and speak either Mandarin Chinese or Taiwanese.
Family caregivers in the DT intervention group must be designated by the patient as recipients of the legacy document. Caregivers must be aged ≥20 years, willing to participate, able to communicate effectively, and able to complete questionnaires independently. Fluency in Mandarin or Taiwanese is required. Caregivers with severe organic brain disorders, mental illness, depression, or cognitive impairment will be excluded.
What does the study involve?
Participants are aged 20 or older and choose to take part voluntarily. They take part in dignity therapy sessions and complete questionnaires to help researchers understand how the therapy affects their emotional well-being.
What are the possible benefits and risks of participating?
Researchers expect that patients who receive dignity therapy will experience less distress related to dignity compared to those receiving standard comfort care. They also anticipate that both patients and their families will find the therapy acceptable and helpful. No major risks are reported.
Where is the study run from?
The study takes place in two oncology wards at a large hospital in southern Taiwan.
When is the study starting and how long is it expected to run for?
The study runs from April to June 2022.
Who is funding the study?
The study is funded by Taiwan’s National Science and Technology Council (NSTC).
Who is the main contact?
Wei-Shu Lai, weisue@mail.ncku.edu.tw
Contact information
Public, Principal investigator
No. 138, Shengli Rd., North Dist.
Tainan city
704302
Taiwan
| Phone | +886-6-2353535 ext.5821 |
|---|---|
| weisue@mail.ncku.edu.tw |
Scientific
No. 138, Shengli Rd., North Dist.
Tainan city
704302
Taiwan
| Phone | +886-6-2353535 ext.5821 |
|---|---|
| olmd0630@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Quasi-experimental non-randomized controlled design |
| Secondary study design | Quasi-experimental study |
| Study type | Participant information sheet |
| Scientific title | Cultural acceptability and potential effectiveness of dignity therapy (DT) for patients with terminal cancer in Taiwan: a quasi-experimental study |
| Study acronym | DTIT |
| Study objectives | 1. Patients receiving DT would report greater reductions in dignity-related distress over time than those receiving comfort care alone 2. DT would be perceived as acceptable and satisfactory by both patients and their family members |
| Ethics approval(s) |
Approved 09/04/2022, Institutional Review Board of National Cheng Kung University (No. 138, Shengli Rd., North District, Tainan City, 704302, Taiwan; +886 2757575; em51020@email.ncku.edu.tw), ref: A-ER-109-193 |
| Health condition(s) or problem(s) studied | Cancer dignity-related distress |
| Intervention | Participants in the intervention group received a standardized 7-day course of dignity therapy in addition to the standard comfort care provided to the control group. Participants in the control group received standard comfort care in accordance with institutional comfort care protocols. Eligible participants were referred by the clinical care team. After providing informed consent, group assignment was initiated. Due to the narrative and emotionally reflective nature of DT, full randomization was not feasible. Participants who expressed a preference for DT were directly assigned to the intervention group, while the remaining eligible participants were randomly allocated to either the intervention or control group using block randomization sequences (e.g., EECC, CCEE). An independent research assistant conducted the randomization, and a senior research coordinator supervised the allocation process to ensure procedural integrity and transparency. Participants who withdrew from the study continued to receive standard care. Blinding of participants and intervention providers was not possible due to the nature of the intervention. However, to mitigate bias, self-reported questionnaires were used for outcome measurement, and participants were provided adequate time and privacy to complete them. Importantly, research personnel responsible for data collection and analysis were blinded to group allocation to enhance objectivity and minimize response bias. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Dignity-related distress was measured using the Patient Dignity Inventory–Mandarin Version (PDI-MV) at baseline, post-intervention, and two-week follow-up |
| Key secondary outcome measure(s) |
Acceptability was assessed using the Dignity Therapy Patient and Family Feedback Questionnaires (DTPFQ/DTFFQ) at post-intervention |
| Completion date | 01/06/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 20 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 63 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Aged 20 years or older 2. Voluntarily agreed to participate 3. Capable of effective communication and completing self-report questionnaires 4. Fluent in either Mandarin Chinese or Taiwanese 5. Diagnosed with terminal cancer with a medically estimated life expectancy of less than six months (added 19/12/2025) Family caregivers in the DT intervention group: 1. Designated by the patient as recipients of the legacy document 2. Aged ≥20 years 3. Willing to participate 4. Able to communicate effectively 5. Able to complete questionnaires independently. Fluency in Mandarin or Taiwanese is required |
| Key exclusion criteria | 1. Diagnosis of a severe organic brain disorder 2. The presence of a diagnosed mental illness or depression 3. Unconsciousness or cognitive impairment 4. Expected hospital discharge within three days 5. Currently receiving formal palliative care (added 19/12/2025) Family caregivers in the DT intervention group: 1. Caregivers with severe organic brain disorders, mental illness, depression, or cognitive impairment . |
| Date of first enrolment | 27/04/2022 |
| Date of final enrolment | 01/06/2022 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Tainan city
704302
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/12/2025: The following changes were made to the study record:
1. The key inclusion criteria were updated.
2. The key exclusion criteria were updated.
3. The plain English summary was updated to reflect these changes.
11/11/2025: Trial's existence confirmed by Institutional Review Board of National Cheng Kung University.
