NCT06962553

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started May 2025

Typical duration for all trials

Status
not yet recruiting

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 Progress38%
May 2025Dec 2027

First Submitted

Initial submission to the registry

April 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 8, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

May 8, 2025

Status Verified

April 1, 2025

Enrollment Period

8 months

First QC Date

April 22, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

survival analysisprojections and predictionspalliative carehospice and palliative care nursingnurses's role

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    From enrollment to the end of treatment at 2.5 years

  • Palliative nurses' perceptions of their roles in prognostic prediction

    From enrollment to the end of treatment at 2.5 years

  • Themes which affect palliative nurses' prognostic prediction and level of confidence

    From enrollment to the end of treatment at 2.5 years

Study Arms (2)

Nurses

Doctors

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • Nurses who are the primary care nurse of the included patients
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Chia Chung Tang, PhD

CONTACT

Tzu Yuan Yeh, BS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2025

First Posted

May 8, 2025

Study Start

May 8, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

May 8, 2025

Record last verified: 2025-04