Clinical trial NCT04375566: Progressive Web App About Individualized Patient Decision Aid for NSCLC Stage I-II
Official title: Improving Decision Making by Developing and Testing a Progressive Web App About Patient Decision Aid for Stage I-II Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer Stage I
Lung Cancer Stage II
Keywords: iPDA
Shared decision making
Patient decision aids
Progressive web app
Lead sponsor: Maastricht University
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Included early stage lung cancer patients and doctors. 10-20 doctors 15 patients More than 20 IT specialists

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability of PDA
timeFrame: 1 year
measure: The accuracy of the information in the tool
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Iva Halilaj
state: Limburg
Study officials:
References: