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Progressive Web App About Individualized Patient Decision Aid for NSCLC Stage I-II

M

Maastricht University

Status

Unknown

Conditions

Lung Cancer Stage I
Lung Cancer Stage II

Treatments

Other: Patient Decision Aid

Study type

Observational

Funder types

Other

Identifiers

NCT04375566
UM_iPDA_PM

Details and patient eligibility

About

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.

Full description

A pilot study in which semi-structured interviews will be conducted (Qualitative research).In addition, patients will be asked to fill in a questionnaire about the usability of the prototype. A small group of patients (n=15) that have been treated for early stage NSCLC in the past will be asked to participate. The persons involved in this pilot are asked to assess a patient decision tool and will be interviewed only once. After the interview they will be asked to fill in a questionnaire. The burden of the pilot study is very low. No medical examinations or procedures will be carried out. Pilot study in lung cancer patients treated in the past with radiotherapy or surgery. The participants will all give informed consent. The investigators are using a qualitative design. Semi-structured interviews will be carried out. In addition the investigators will ask the participants to fill in a questionnaire with 35 questions.

No age limits are defined. The pilot study will be carried out in stage I-II NSCLC patients who were treated with radiotherapy or surgery, at least 6 months ago. Patients should currently be free of disease, no disease progression. The semi-structured interview consists of 17 open questions and text recorded, in order to be able to analyze the date afterwards. The interviews will take place when the patients come to the hospital for a regular follow-up appointment. After the interview, the patient is asked to fill in a questionnaire about the usability of the decision aid. In total, the expected duration is about 2 hours.

Enrollment

45 estimated patients

Sex

All

Ages

21 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Others

Trial design

45 participants in 3 patient groups

IT specialist
Description:
20 IT Specialist will evaluate the usability and patient-friendliness of the tool
Treatment:
Other: Patient Decision Aid
Doctors
Description:
13 doctors will evaluate the information in the tool
Treatment:
Other: Patient Decision Aid
Patients
Description:
10-20 patients will evaluate the utility and the contribution of the tool in decision making proces.
Treatment:
Other: Patient Decision Aid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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