NCT04969952

Brief Summary

Evaluation of an Interventional module to assist physicians introducing ACP to cancer patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

April 6, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

2.5 years

First QC Date

June 29, 2021

Last Update Submit

June 16, 2024

Conditions

Cancer Patients

Keywords

ACP brochureInterventional ModuleAdvance directivecancer patients

Outcome Measures

Primary Outcomes (1)

  • Sign DNR (Do-Not-Resuscitate)

    After intervention cancer patients willing sing DNR

    3 month

Secondary Outcomes (1)

  • Completion AD(Advance directive) documentation

    3 month

Other Outcomes (1)

  • Explain and predict health behaviors(Sign DNR / Completion AD)

    3 month

Study Arms (2)

Group A

EXPERIMENTAL

Group A had watching educational module plus ACP brochure

Other: For interventional module

Group B

ACTIVE COMPARATOR

Group B ACP brochure only

Other: For interventional module

Interventions

For interventional moduleOTHER

Using vedio to assist physicians introducing advance care planning to cancer patients

Group AGroup B

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Older than 20-years-old
  • Diagnosed with cancer
  • Have not signed any form of AD or DNR
  • Under 20-years-old
  • Can not speak or listen, difficult communication
  • Signed AD or DNR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nation Taiwan University Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei County, Taiwan

Location

Study Officials

  • Shao-Yi Cheng Shao-Yi, PHD

    Shao-Yi Cheng

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Only investigator know
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Shared decision making (SDM) process through Advance Care Planning (ACP) consultation with cancer patients
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 21, 2021

Study Start

April 6, 2021

Primary Completion

September 20, 2023

Study Completion

December 20, 2023

Last Updated

June 18, 2024

Record last verified: 2024-06

Locations

TW(2)