Lung Non-Small Cell CarcinomaNCT04946279
Decision Aid for the Improvement of Decision-Making in Patients With Non-small Cell Lung Cancer
A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by OHSU Knight Cancer Institute at 2 sites in United States.
Trial summary
This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8
- What is being tested?
- Best Practice, Informational Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2020to 14 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC)
- PART I: English fluency
- PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC
- PART II: English fluency
- PART II: > 6-month life expectancy
- PART II: Score of > 3 on the 6-Item Screener for Cognitive Impairment
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OHSU Knight Cancer Institute
Portland, Oregon, 97239
Portland VA Medical Center
Portland, Oregon, 97239
About this study
Official title: Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool
This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.
II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive the conversation tool.
ARM II: Patients receive usual care.
Patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.
- Conditions
- Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Being tested
- Best Practice, Informational Intervention, Questionnaire Administration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual/standard of care
Informational InterventionOther
Receive conversation tool
Questionnaire AdministrationOther
Ancillary studies - Baseline and follow-up questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Arm I (conversation tool) | Experimental | Patients receive the conversation tool. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
| Arm II (usual care) | Active comparator | Patients receive usual care. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the conversation tool
The number of patients enrolled divided by the number of patients offered enrollment.
Measured: At enrollment
Acceptability of the conversation tool
The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool.
Measured: At enrollment
Secondary outcomes (8)
Anxiety
Assessed using the Hospital Anxiety and Depression Scale.
Measured: From enrollment to the end of follow-up at 8 weeks
Decisional conflict
Assessed using the Decisional Conflict Scale.
Measured: At the end of follow-up at 8 weeks
Decisional Regret
Assessed using the Decisional Regret Scale.
Measured: At the end of follow-up at 8 weeks
Perceived involvement in care
Assessed using the Perceived Involvement in Care Scale.
Measured: At the end of follow-up at 8 weeks
Shared decision-making quality
Assessed using the Shared Decision Making Questionnaire.
Measured: At the end of follow-up at 8 weeks
Decision making involvement
Assessed using the Control Preferences Scale.
Measured: From enrollment to the end of follow-up at 8 weeks
Self-efficacy
Assessed using the Decision Self-Efficacy Scale.
Measured: From enrollment to the end of follow-up at 8 weeks
Values-treatment concordance
Assessed using electronic medical record (EMR).
Measured: From enrollment to the end of follow-up at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start7 Aug 2020
- Primary completion13 Jan 2023
- Study completion14 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, ATS Foundation, Hildegard Lamfrom Endowment, Medical Research Foundation, Oregon
- Responsible party
- Principal investigator, Donald R Sullivan, MD, MA, MCR, OHSU Knight Cancer Institute
- Investigators
- Donald Sullivan, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946279
- Sponsor's protocol ID
- STUDY00020688
- Other IDs
- NCI-2021-05887, STUDY00020688
- Status last verified
- Sep 2026
- First submitted
- 23 Jun 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sullivan DR, Dieckmann NF, Franklin H, Matlock DD, Coleman CA, Saha S, Golden SE, Disher NG, Slatore CG, Vranas KC, Hayes S, Lee P, Mudambi L, Eden KB. Improving Decision-Making Encounters in Lung Cancer Treatment: Feasibility and Acceptability of a Low-Literacy Conversation Tool (iDECIDE). CHEST Pulm. 2025 Jan 31;3(3):100144. doi: 10.1016/j.chpulm.2025.100144. eCollection 2025 Sep.
PubMed 42548403
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Decision-Making Encounters in Lung Cancer (I DECide): A Low-Literacy Conversation Tool
- ClinicalTrials.gov ID
- NCT04946279
- Acronym / sponsor ID
- STUDY00020688
- Conditions
- Lung Non-Small Cell Carcinoma, Stage I Lung Cancer AJCC v8, Stage II Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, ATS Foundation, Hildegard Lamfrom Endowment, Medical Research Foundation, Oregon
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial refines and tests the effect of a decision aid in improving decision-making in patients with non-small cell lung cancer. Patients with cancer want to be informed about their diagnoses, treatment procedures and goals of treatment. They also seek active roles in decision-making. Shared decision-making (SDM) is the process of clinician and patient jointly participating in a health decision after discussing the options, benefits and harms, and considering the patient's values, preferences, and circumstances. SDM can improve patient involvement in decision making, satisfaction, health care quality, and quality of life. Decision aids can improve patient knowledge, create more realistic outcome expectations; reduce decisional conflict, distress, depression and uncertainty; and improve physician-patient communication and quality of life, compared with no decision aid. This trial's main aim is to evaluate the feasibility and efficacy of a decision aid in patients with non-small cell lung cancer.
Detailed description
PRIMARY OBJECTIVES:
- Refine a conversation tool among patients with lung cancer by conducting prototype testing in an iterative process.
II. Conduct a trial at two comprehensive cancer treatment centers representing academic and Veterans Affairs medical centers.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive the conversation tool.
ARM II: Patients receive usual care.
Patients in both arms are followed up within 4-8 weeks after baseline to complete a second questionnaire.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (conversation tool) | Experimental | Other: Informational Intervention, Other: Questionnaire AdministrationPatients receive the conversation tool. |
| Arm II (usual care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive usual care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- PART I: Completed treatment for suspected or confirmed stage I-IV non-small cell lung cancer (NSCLC)
- PART I: English fluency
- PART II: Undergoing diagnostic work-up for suspected stage I-IV NSCLC
- PART II: English fluency
- PART II: > 6-month life expectancy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual/standard of care | Other | Arm II (usual care) |
| Informational InterventionReceive conversation tool | Other | Arm I (conversation tool) |
| Questionnaire AdministrationAncillary studies - Baseline and follow-up questionnaires | Other | Arm I (conversation tool), Arm II (usual care) |
Primary outcome
Feasibility of the conversation tool
Time frame: At enrollment
The number of patients enrolled divided by the number of patients offered enrollment.
Acceptability of the conversation tool
Time frame: At enrollment
The number of participants who completed the conversation tool divided by the number of participants who began the conversation tool.
8 secondary outcomes
Anxiety
Time frame: From enrollment to the end of follow-up at 8 weeks
Decisional conflict
Time frame: At the end of follow-up at 8 weeks
Decisional Regret
Time frame: At the end of follow-up at 8 weeks
Perceived involvement in care
Time frame: At the end of follow-up at 8 weeks
Shared decision-making quality
Time frame: At the end of follow-up at 8 weeks
Decision making involvement
Time frame: From enrollment to the end of follow-up at 8 weeks
Self-efficacy
Time frame: From enrollment to the end of follow-up at 8 weeks
Values-treatment concordance
Time frame: From enrollment to the end of follow-up at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 42548403Sullivan DR, Dieckmann NF, Franklin H, Matlock DD, Coleman CA, Saha S, Golden SE, Disher NG, Slatore CG, Vranas KC, Hayes S, Lee P, Mudambi L, Eden KB. Improving Decision-Making Encounters in Lung Cancer Treatment: Feasibility and Acceptability of a Low-Literacy Conversation Tool (iDECIDE). CHEST Pulm. 2025 Jan 31;3(3):100144. doi: 10.1016/j.chpulm.2025.100144. eCollection 2025 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Sullivan principal investigator
OHSU Knight Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Informational Intervention and Questionnaire Administration in people with Lung Non-Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by OHSU Knight Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the conversation tool (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04946279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.