NCT04375566

Brief Summary

Studies indicate that the majority of early-stage non-small cell lung cancer (NSCLC) patients find it important to be involved in treatment decision making. However, in a recent study it has been reported that about 40% of the participants experienced decision conflict and feel uninformed(1). The investigators therefore developed a patient decision aid (PDA) for stage I-II NSCLC patients, that informs and empowers patients to help decide between stereotactic radiotherapy (SBRT) and surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

May 1, 2020

Last Update Submit

August 24, 2021

Conditions

Lung Cancer Stage ILung Cancer Stage II

Keywords

iPDAShared decision makingPatient decision aidsProgressive web app

Outcome Measures

Primary Outcomes (2)

  • Usability of PDA

    Opinion of the respondents about patient decision aid

    1 year

  • The accuracy of the information in the tool

    Testing the information provided in the tool and the usability of the tool itself

    1 year

Study Arms (3)

IT specialist

20 IT Specialist will evaluate the usability and patient-friendliness of the tool

Other: Patient Decision Aid

Doctors

13 doctors will evaluate the information in the tool

Other: Patient Decision Aid

Patients

10-20 patients will evaluate the utility and the contribution of the tool in decision making proces.

Other: Patient Decision Aid

Interventions

Patient Decision AidOTHER

More than 20 IT specialists, 15 doctors and 15 patients

DoctorsIT specialistPatients

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Included early stage lung cancer patients and doctors. 10-20 doctors 15 patients More than 20 IT specialists

You may qualify if:

  • Early stage non-small cell lung patients, Treated with curative intent minimum 6 month ago, max 5 years. Doctors IT

You may not qualify if:

  • Others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iva Halilaj

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 5, 2020

Study Start

October 4, 2021

Primary Completion

January 31, 2022

Study Completion

February 28, 2022

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)