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NCT Number: NCT05407168

Improving Decision-Making Encounters in Lung Cancer Using 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.

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Key information

Conditions

Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hillsboro Medical Center, Hillsboro, Oregon, United States

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About this study

PRIMARY OBJECTIVES:

I. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Health Promotion and Education

Other

View decision aid

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. FACT-L

    Time frame: Up to 6 months.

    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.

  2. Depression/Anxiety

    Time frame: Up to 6 months

    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.

  3. Participation in Decision-Making

    Time frame: Up to 6 months

    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."

  4. Decision Regret

    Time frame: Up to 6 months

    Will be assessed using the 5-item Decision Regret Scale. Higher scores indicate high regret.

  5. Quality of Communication

    Time frame: Up to 6 months

    Will be assessed using the ~30 item Patient Assessment of cancer Communication Experiences scale. Higher scores indicate higher perceived quality of communication.

  6. Number of Palliative Care Referrals

    Time frame: Up to 6 months

    Will be assessed by conducting chart review

  7. Treatment Decision-Making Concordance

    Time frame: Up to 6 months

    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.

  8. Acceptability

    Time frame: Up to 6 months

    Will be assessed using the Ottawa Acceptability scale for patients in the intervention group only.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • American Cancer Society, Inc.
  • Oregon Health and Science University

Registry information

Official study title

Improving Decision-Making Encounters in Lung Cancer (I DECide) II: A Randomized Control Trial Of A Low-Literacy Conversation Tool

Acronym: iDECIDE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jun 7, 2022
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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