Lung CarcinomaiDECIDENCT05407168
Improving Decision-Making Encounters in Lung Cancer Using a Low-Literacy Conversation Tool
A study testing Best Practice, Health Promotion and Education and Questionnaire Administration in people with Lung Carcinoma, run by OHSU Knight Cancer Institute at 4 sites in United States.
Trial summary
This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Best Practice, Health Promotion and Education and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 4 sitesUnited States
- Study dates
- 31 Oct 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AIM 1: Suspected lung cancer
- AIM 1: English fluency
- AIM 1: > 6-month life expectancy
- AIM 1: Score of ≥ 3 on the cognitive impairment screener
- AIM 2 PARTICIPANTS: Participation in Aim 1
- AIM 2 CLINICIANS: Discussing lung cancer treatment decisions with Aim 1 participants
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hillsboro Medical Center
Hillsboro, Oregon, 97123
Adventist Health Portland
Portland, Oregon, 97216
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) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool
This clinical trial evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.
Read the detailed description
PRIMARY OBJECTIVES:
- Conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. A subset of participants from control and intervention groups will also have their clinic conversations with providers recorded II. Conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of Aim 1 participants.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients review decision aid.
GROUP II: Patients receive standard of care.
After completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.
- Conditions
- Lung Carcinoma
- Being tested
- Best Practice, Health Promotion and Education, Questionnaire Administration
- Medical subject headings
- 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 standard of care
Health Promotion and EducationOther
View decision aid
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (decision aid) | Experimental | Patients review decision aid. Receives: Other: Health Promotion and Education; Other: Questionnaire Administration |
| Group II (standard of care) | Active comparator | Patients receive standard of 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.
Decision Conflict
Will be assessed using the Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict.
Measured: Up to 6 months
Efficacy of a conversation tool on patients' knowledge of lung cancer
Will be assessed using nine questions from previously validated measures.
Measured: Up 6 months
Satisfaction with Communication/Confidence in Decision
Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes.
Measured: Up to 6 months
Self-Efficacy
Will be assessed using the Decision Self-Efficacy Scale which contains 11 items. Higher scores indicate higher self-efficacy.
Measured: Up to 6 months
Secondary outcomes (8)
FACT-L
Quality of Life will be assessed by the Functional Assessment of Cancer Therapy -- Lung scale. This scale has 27 items. Higher scores indicate higher quality of life.
Measured: Up to 6 months.
Depression/Anxiety
Will be assessed using the 4 item Patient Health Questionnaire for Anxiety and Depression scale. Scores greater than or equal to 3 on the first two questions suggest anxiety, and scores greater than or equal to 3 on the last two questions suggest depression.
Measured: Up to 6 months
Participation in Decision-Making
Will be assessed using the 2-item Control Preferences Scale. Answers of 1 or 2 on both items are categorized as "patient controlled", answers of 3 are categorized as "shared", and answers of 4 or 5 are categorized as "physician-controlled."
Measured: Up to 6 months
Decision Regret
Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret.
Measured: Up to 6 months
Quality of Communication
Will be assessed using the ~30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication.
Measured: Up to 6 months
Number of Palliative Care Referrals
Will be assessed by conducting chart review
Measured: Up to 6 months
Treatment Decision-Making Concordance
Will be assessed by observing the treatment received and the treatment most aligned with responses to the conversation tool. If the treatment received is the same treatment the patient preferred according to the conversation tool, the treatment decision will be considered concordant.
Measured: Up to 6 months
Acceptability
Will be assessed using the Ottawa Acceptability scale for patients in the intervention group only.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start31 Oct 2022
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, American Cancer Society, Inc.
- Responsible party
- Principal investigator, Donald R Sullivan, MD, MA, MCR, OHSU Knight Cancer Institute
- Investigators
- Donald R Sullivan, MD, MA, MCR, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407168
- Sponsor's protocol ID
- STUDY00023160
- Other IDs
- NCI-2021-09819, STUDY00023160
- Acronym
- iDECIDE
- Status last verified
- Sep 2026
- First submitted
- 5 Oct 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Disher N, Dieckmann NF, Case JR, Rubim F, Eden KB, Golden SE, Matlock DD, Coleman C, Lyons KS, Saha S, Slatore CG, Vranas KC, Sullivan DR. Improving lung cancer decision-making using a conversation tool (iDECIDE): a stepped wedge pragmatic clinical trial. Future Oncol. 2025 Apr;21(9):1045-1056. doi: 10.1080/14796694.2025.2475733. Epub 2025 Mar 18.
PubMed 40098532
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 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) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool
- ClinicalTrials.gov ID
- NCT05407168
- Acronym / sponsor ID
- iDECIDE / STUDY00023160
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 237 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, American Cancer Society, Inc.
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Jun 2022 (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 evaluates the effectiveness of a conversation tool on patient-centered health and decision-making outcomes in patients with lung cancer making treatment decisions. This research is being conducted to help doctors understand the information patients need to participate in shared decision-making about their lung cancer treatment options. The focus of this research is to study how patients choose lung cancer treatment options and the information needed to make that choice, with a focus on patients with lower health literacy.
Detailed description
PRIMARY OBJECTIVES:
- Conduct a randomized, controlled trial evaluating the efficacy of a conversation tool on patient-centered health and decision-making outcomes among patients making lung cancer treatment decisions. A subset of participants from control and intervention groups will also have their clinic conversations with providers recorded II. Conduct in-depth, semi-structured qualitative audio or video recorded interviews among a subset of Aim 1 participants.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients review decision aid.
GROUP II: Patients receive standard of care.
After completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (decision aid) | Experimental | Other: Health Promotion and Education, Other: Questionnaire AdministrationPatients review decision aid. |
| Group II (standard of care) | Active comparator | Other: Best Practice, Other: Questionnaire AdministrationPatients receive standard of care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- AIM 1: Suspected lung cancer
- AIM 1: English fluency
- AIM 1: > 6-month life expectancy
- AIM 1: Score of ≥ 3 on the cognitive impairment screener
- AIM 2 PARTICIPANTS: Participation in Aim 1
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 standard of care | Other | Group II (standard of care) |
| Health Promotion and EducationView decision aid | Other | Group I (decision aid) |
| Questionnaire AdministrationAncillary studies | Other | Group I (decision aid), Group II (standard of care) |
Primary outcome
Decision Conflict
Time frame: Up to 6 months
Will be assessed using the Decisional Conflict Scale, which contains 16 items. Higher scores indicate higher decisional conflict.
Efficacy of a conversation tool on patients' knowledge of lung cancer
Time frame: Up 6 months
Will be assessed using nine questions from previously validated measures.
Satisfaction with Communication/Confidence in Decision
Time frame: Up to 6 months
Will be assessed using the 20-item COMRADE scale. Higher scores indicate better outcomes.
Self-Efficacy
Time frame: Up to 6 months
Will be assessed using the Decision Self-Efficacy Scale which contains 11 items. Higher scores indicate higher self-efficacy.
8 secondary outcomes
FACT-L
Time frame: Up to 6 months.
Depression/Anxiety
Time frame: Up to 6 months
Participation in Decision-Making
Time frame: Up to 6 months
Decision Regret
Time frame: Up to 6 months
Quality of Communication
Time frame: Up to 6 months
Number of Palliative Care Referrals
Time frame: Up to 6 months
Treatment Decision-Making Concordance
Time frame: Up to 6 months
Acceptability
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 40098532Disher N, Dieckmann NF, Case JR, Rubim F, Eden KB, Golden SE, Matlock DD, Coleman C, Lyons KS, Saha S, Slatore CG, Vranas KC, Sullivan DR. Improving lung cancer decision-making using a conversation tool (iDECIDE): a stepped wedge pragmatic clinical trial. Future Oncol. 2025 Apr;21(9):1045-1056. doi: 10.1080/14796694.2025.2475733. Epub 2025 Mar 18.
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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 R Sullivan, MD, MA, MCR principal investigator
OHSU Knight Cancer Institute
4 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, Health Promotion and Education and Questionnaire Administration in people with Lung Carcinoma, run by OHSU Knight Cancer Institute at 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
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?
Decision Conflict (time frame: Up to 6 months). The study lists 4 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 NCT05407168, 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 2 Sep 2026.