Advanced CancerNCT06962553
Nurses' Competence and Role in Survival Prediction and Prognostic Communication
An observational study of Advanced Cancer and Terminal Malignant Tumors, run by National Taiwan University Hospital.
Trial summary
[Background] Nurses' roles in survival prediction and prognostic communication have historically been limited due to role delineation, lack of formal training, and cultural norms. In Taiwan and other cultural contexts, prognostic discussions have traditionally been the purview of physicians. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Terminal Malignant Tumors, Hospices
- How many people
- 152 participants
- Where
- No sites listed yet
- Study dates
- 8 May 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The research team at each site will identify eligible patients in the palliative and hospice unit and invite their physicians and nurses to participate the study.
Who may be able to join
- [Inclusion criteria for patients]
- 18 years old or older
- Diagnosed with advanced solid cancer, including locally extensive or metastasis cancer
- Patients admitted to palliative care units or oncology units in the participating institutions.
- [Inclusion criteria for clinicians]
- Nurses who are the primary care nurse of the included patients
Show all 10Show fewer
- Nurses who care for the included patients for at least one shift
- Nurses who work in palliative and hospice units or team, or oncology units for over 6 months.
- Physicians who are palliative care specialists and/or physicians with palliative care trainings
- Physicians who are the primary care physician of the included patient.
Who cannot join
- Patients with hematological malignancies are excluded.
- A participated clinicians can only participate in the study up to three times, clinicians who participate in the study for more than three times are excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Nurses' Competence and Role in Survival Prediction and Prognostic Communication: A Taboo, an Aid, or a Necessity? A Multinational Mixed- Methods Study
[Background] Nurses' roles in survival prediction and prognostic communication have historically been limited due to role delineation, lack of formal training, and cultural norms. In Taiwan and other cultural contexts, prognostic discussions have traditionally been the purview of physicians. However, evolving paradigms in health communication, practical realities in nursing practice, and the expanded responsibilities of advanced practice nurses have highlighted the importance of nurses in this domain. Nurses frequently engage in "foreseeing" prognostic indicators through daily patient care, and emerging evidence suggests their prognostic accuracy is often comparable to or exceeds that of physicians. Despite this, the exact scope of nurses' roles in prognostication remains unclear, creating gaps in understanding the contributions, benefits, and associating factors of nurses' involvement of prognostication process.
[Aim] This mixed-methods study aims to examine hospice nurses' competencies and roles in prognostication, with a focus on their survival prediction accuracy, confidence, influencing factors, and self-perceived responsibilities.
Read more
[Method] This three-year, cross-national study adopts an explanatory sequential mixed-methods design. First, the quantitative phase utilizes a prospective cohort design, recruiting palliative nurses and physicians from ten palliative care sites across three countries. Eligible clinicians include nurses and physicians who provide care for patients with advanced cancer in palliative care settings or oncologic wards. Participating clinicians will provide weekly prognostic predictions for targeted patients and rate their confidence levels. Patients' demographic and disease-related information will also be collected to estimate survival using prediction tools. Data collection will conclude upon the patient's death or discharge. Based on the results of the quantitative phase, a descriptive qualitative study will be conducted to purposefully recruit nurses with varying levels of prediction accuracy and confidence from the quantitative phase. Semi-structured interviews will be carried out to gather qualitative data on their perspectives regarding prognostication, with a particular focus on their roles. The estimated sample size for quantitative phase is 152 nurse-physician dyads (based on 152 patients), while 20-30 nurses are expected to participate in the qualitative phase.
[Data Analysis] Descriptive statistics, area under the receiver operating characteristic (ROC) curve (AUC), Cohen's kappa, weighted kappa, McNemar's test, and ordinal logistic regression will be used to analyze quantitative data. Qualitative data will be analyzed using conventional content analysis. Nurses' Competence and Role in Survival Prediction and Prognostic Communication.
[Expecting Outcomes and Conclusion] This project uniquely highlights nurses' contributions to prognostication, aiming to generate evidence that informs future research, clinical practice, and policy development. The findings will shed light on nurses' roles, functions, potential benefits, and the barriers the face in prognostication.
- Conditions
- Advanced Cancer, Terminal Malignant Tumors, Hospices
- Keywords
- survival analysis, projections and predictions, palliative care, hospice and palliative care nursing, nurses's role
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nurses | Not described | |
| Doctors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palliative nurses' accuracy in making survival prediction
The results of predicted survival time estimated by participants should be specified within a range of days to weeks. The accuracy will be measured by comparing their results of prediction to: (1) the patients actual survival, (2) those of physicians, and (3) survival prediction derived from prognostic tools.
Measured: From enrollment to the end of treatment at 2.5 years
Palliative nurses' levels of confidence in making prognostic predictions
The level of confidence will be measured on the scale of 0 to 10.
Measured: From enrollment to the end of treatment at 2.5 years
Secondary outcomes (3)
Relationship between palliative nurses' demographic variables, prognostic confidence, and survival prediction accuracy
Analysis of the association between nurses' demographic factors (e.g., age, years of experience, ward type) and their level of prognostic confidence and accuracy in predicting survival time for terminal cancer patients. Measured using structured questionnaires and comparison with actual survival outcomes.
Measured: From enrollment to the end of treatment at 2.5 years
Palliative nurses' perceptions of their roles in prognostic prediction
Thematic analysis of interview transcripts to explore how nurses describe their roles in prognostic prediction
Measured: From enrollment to the end of treatment at 2.5 years
Themes which affect palliative nurses' prognostic prediction and level of confidence
Identification and thematic analysis of key factors influencing palliative care nurses' prognostic predictions and their level of confidence. Themes will be derived from qualitative data collected through semi-structured and analyzed using content or thematic analysis.
Measured: From enrollment to the end of treatment at 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start8 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962553
- Sponsor's protocol ID
- 202501114RINE
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurses' Competence and Role in Survival Prediction and Prognostic Communication: A Taboo, an Aid, or a Necessity? A Multinational Mixed- Methods Study
- ClinicalTrials.gov ID
- NCT06962553
- Acronym / sponsor ID
- 202501114RINE
- Conditions
- Advanced Cancer, Terminal Malignant Tumors, Hospices
- Keywords
- survival analysis, projections and predictions, palliative care, hospice and palliative care nursing, nurses's role
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 May 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.
[Background] Nurses' roles in survival prediction and prognostic communication have historically been limited due to role delineation, lack of formal training, and cultural norms. In Taiwan and other cultural contexts, prognostic discussions have traditionally been the purview of physicians. However, evolving paradigms in health communication, practical realities in nursing practice, and the expanded responsibilities of advanced practice nurses have highlighted the importance of nurses in this domain. Nurses frequently engage in "foreseeing" prognostic indicators through daily patient care, and emerging evidence suggests their prognostic accuracy is often comparable to or exceeds that of physicians. Despite this, the exact scope of nurses' roles in prognostication remains unclear, creating gaps in understanding the contributions, benefits, and associating factors of nurses' involvement of prognostication process.
[Aim] This mixed-methods study aims to examine hospice nurses' competencies and roles in prognostication, with a focus on their survival prediction accuracy, confidence, influencing factors, and self-perceived responsibilities.
[Method] This three-year, cross-national study adopts an explanatory sequential mixed-methods design. First, the quantitative phase utilizes a prospective cohort design, recruiting palliative nurses and physicians from ten palliative care sites across three countries. Eligible clinicians include nurses and physicians who provide care for patients with advanced cancer in palliative care settings or oncologic wards. Participating clinicians will provide weekly prognostic predictions for targeted patients and rate their confidence levels. Patients' demographic and disease-related information will also be collected to estimate survival using prediction tools. Data collection will conclude upon the patient's death or discharge. Based on the results of the quantitative phase, a descriptive qualitative study will be conducted to purposefully recruit nurses with varying levels of prediction accuracy and confidence from the quantitative phase. Semi-structured interviews will be carried out to gather qualitative data on their perspectives regarding prognostication, with a particular focus on their roles. The estimated sample size for quantitative phase is 152 nurse-physician dyads (based on 152 patients), while 20-30 nurses are expected to participate in the qualitative phase.
[Data Analysis] Descriptive statistics, area under the receiver operating characteristic (ROC) curve (AUC), Cohen's kappa, weighted kappa, McNemar's test, and ordinal logistic regression will be used to analyze quantitative data. Qualitative data will be analyzed using conventional content analysis. Nurses' Competence and Role in Survival Prediction and Prognostic Communication.
[Expecting Outcomes and Conclusion] This project uniquely highlights nurses' contributions to prognostication, aiming to generate evidence that informs future research, clinical practice, and policy development. The findings will shed light on nurses' roles, functions, potential benefits, and the barriers the face in prognostication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurses | – | – |
| Doctors | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The research team at each site will identify eligible patients in the palliative and hospice unit and invite their physicians and nurses to participate the study.
Key inclusion criteria (10 listed)
- [Inclusion criteria for patients]
- 18 years old or older
- Diagnosed with advanced solid cancer, including locally extensive or metastasis cancer
- Patients admitted to palliative care units or oncology units in the participating institutions.
- [Inclusion criteria for clinicians]
Key exclusion criteria (2 listed)
- Patients with hematological malignancies are excluded.
- A participated clinicians can only participate in the study up to three times, clinicians who participate in the study for more than three times are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Palliative nurses' accuracy in making survival prediction
Time frame: From enrollment to the end of treatment at 2.5 years
The results of predicted survival time estimated by participants should be specified within a range of days to weeks. The accuracy will be measured by comparing their results of prediction to: (1) the patients actual survival, (2) those of physicians, and (3) survival prediction derived from prognostic tools.
Palliative nurses' levels of confidence in making prognostic predictions
Time frame: From enrollment to the end of treatment at 2.5 years
The level of confidence will be measured on the scale of 0 to 10.
3 secondary outcomes
Relationship between palliative nurses' demographic variables, prognostic confidence, and survival prediction accuracy
Time frame: From enrollment to the end of treatment at 2.5 years
Palliative nurses' perceptions of their roles in prognostic prediction
Time frame: From enrollment to the end of treatment at 2.5 years
Themes which affect palliative nurses' prognostic prediction and level of confidence
Time frame: From enrollment to the end of treatment at 2.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Cancer and Terminal Malignant Tumors, run by National Taiwan University Hospital.
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 10 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: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia Chung Tang, PhD (+88623123456 ext. 288436, chiatang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palliative nurses' accuracy in making survival prediction (time frame: From enrollment to the end of treatment at 2.5 years). The study lists 2 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 8 May 2025.