UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055292 |
|---|---|
| Receipt number | R000063179 |
| Scientific Title | A Prospective Observational Study on the Usefulness of Decision Support Tools and Factors Influencing Treatment Choices in Early-Stage Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2024/08/20 |
| Last modified on | 2026/01/21 12:49:27 |
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Basic information
Public title
Evaluation of the Usefulness of Decision Support Tools and Factors Influencing Treatment Choices in Early-Stage Non-Small Cell Lung Cancer
Acronym
DAT Study (Decision Aid Tool Study)
Scientific Title
A Prospective Observational Study on the Usefulness of Decision Support Tools and Factors Influencing Treatment Choices in Early-Stage Non-Small Cell Lung Cancer
Scientific Title:Acronym
Decision Aid Research (DAR)
Region
| Japan |
Condition
Condition
Early-Stage Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of a treatment decision-making guide for patients with early-stage non-small cell lung cancer based on questionnaire results and to analyze factors influencing treatment choices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire results on the decision-making guide for early-stage lung cancer patients
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients definitively diagnosed with or strongly suspected of having early-stage non-small cell lung cancer
2. Patients with clinical stage cT1N0M0 or cT2N0M0
3. Patients eligible for surgical treatment or SBRT for lung cancer
4. Patients aged 18 years or older
5. No gender restrictions
Key exclusion criteria
1. Patients unable to appropriately use the treatment decision-making guide
2. Patients with a pre-determined treatment plan
3. Other patients deemed unsuitable by the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kaneko |
Organization
Yokohama City University
Division name
Department of Respiratory Medicine
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872800
takeshi@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Pulmonology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872800
Homepage URL
nkobayas@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Yokohama City University
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
0457872800
nkobayas@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
Results
Among 26 eligible patients, 24 completed the PDA evaluation. All participants (100%) reported improved understanding, and 75% experienced reduced anxiety. Final treatment choices were SBRT in 15 patients (57.7%), surgery in 9 (34.6%), and observation in 2 (7.7%), indicating a shift toward SBRT compared to historical trends in Japan.
Results date posted
| 2026 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The analysis included 26 patients with a median age of 74 years (range 52-87). There were 12 males (46.2%) and 14 females (53.8%). The majority of patients presented with clinical stage T1b (38.5%) or T1c (30.8%) disease. Histology was confirmed as adenocarcinoma in 12 patients (46.2%), while 11 (42.3%) were unconfirmed. Most patients (80.8%) had a performance status of 0.
Participant flow
A total of 27 patients provided informed consent. One patient was excluded due to clinical T3 disease, leaving 26 eligible patients who used the PDA and made a treatment selection (surgery, SBRT, or observation). Of these, 24 patients completed the PDA utility evaluation. Two patients who selected observation were excluded from the Decision Conflict Scale (DCS) analysis, resulting in a final analysis set of 22 patients (surgery n=8, SBRT n=14).
Adverse events
No physical adverse events related to the use of the PDA were reported. In the evaluation of the PDA, one patient (4.2%) reported increased anxiety after using the tool, while 75.0% reported reduced anxiety and 20.8% reported no change.
Outcome measures
Primary outcomes included patient-perceived utility of the PDA (improvement in understanding, changes in anxiety, and helpfulness), decisional conflict measured by the Decision Conflict Scale (DCS), and changes in treatment preferences before and after PDA use.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter, prospective observational study aimed at evaluating the usefulness of a treatment decision support tool for patients with early-stage non-small cell lung cancer. After providing the decision-making guide, the study will assess its impact on patients' treatment choices through questionnaires. Observational data will also be used to analyze factors influencing treatment decisions.
Management information
Registered date
| 2024 | Year | 08 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063179
