Novel INPUT Screening Tool to Improve Illness Understanding in Patients With Metastatic or Incurable Lung Cancer

April 28, 2026 updated by: M.D. Anderson Cancer Center

Information Needs, Preferences, and Understanding Trial (INPUT): A Randomized, Controlled Trial of the Effects of a Screening Tool on Illness Understanding

This clinical trial compares the use of a new screening tool designed to evaluate patients' information needs, preferences, and illness understanding to the usual care to improve illness understanding in patients with lung cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or for which no curative treatment is currently available (incurable). Goal concordant care is a model of care that aligns a patient's medical care with their values, preferences, and goals. Often, patients may not fully understand their illness and prognosis, but this information is important so that they can make fully informed decisions regarding their care that are consistent with their values, preferences, and goals. Completing the Information Needs, Preferences, and Understanding Trial (INPUT) screening tool may allow for more frequent and regular discussions regarding disease status and treatment goals, ultimately resulting in improved patient illness understanding and goal concordant care for patients with metastatic or incurable lung cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary Objectives To estimate the within group effect of perception of curability over 3 months in both the systematic screening group and the usual care group among patients with metastatic or incurable lung cancer who present to the thoracic medical oncology clinic at The University of Texas MD Anderson Cancer Center.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Kayley M Ancy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

MD Anderson Cancer Center

Description

Inclusion Criteria:

  • Within 3 months of biopsy-confirmed diagnosis of stage IV lung cancer
  • Age 18 or over
  • English speaking
  • Attending a follow-up visit at the thoracic medical oncology clinic
  • Plans to receive or actively undergoing cancer-directed systemic treatment at MD Anderson

Exclusion Criteria:

• Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm I (Standard care)
Patients undergo standard of care oncology follow-up visits.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Other Best Practice best practice, standard of care, standard of care, standard of care, standard therapy Undergo standard of care oncology follow-up visits
Experimental: Arm II (INPUT screening)
Patients complete the INPUT screening tool at each of their standard of care follow up visits, with their medical oncology team.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Other Best Practice best practice, standard of care, standard of care, standard of care, standard therapy Undergo standard of care oncology follow-up visits

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in illness understanding
Time Frame: At 3 months
Binary curability status is derived from the response to the INPUT Screening survey question #2. Will be similarly modeled by mixed-effect logistic regression.
At 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference between treatment groups in illness understanding
Time Frame: At 3 and 6 months
Based upon the Prigerson Measure of Illness Understanding. The Likert-scale and composite score responses (excluding the acceptability of screening tool assessment) will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts.
At 3 and 6 months
Quality of communication
Time Frame: At 3 and 6 months
Assessed via the Quality of Communication questionnaire. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months
Feeling heard and understood by healthcare team
Time Frame: At 3 and 6 months
Assessed via the Feeling Heard and Understood scale. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months
Death-related anxiety
Time Frame: At 3 and 6 months
Assessed via the Death and Dying Distress scale. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months
Anxiety related symptoms
Time Frame: At 3 and 6 months
Assessed via the Generalized Anxiety Disorder scale. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months
Depression
Time Frame: At 3 and 6 months
Assessed via the Patient Health Questionnaire, 9 items. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months
Health related quality of life
Time Frame: At 3 and 6 months
Assessed via the Functional Assessment of Cancer Therapy - General. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months
Symptoms of advanced cancer
Time Frame: At 3 and 6 months
Assessed via the Edmonton Symptom Assessment System. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months
Acceptability of screening tool
Time Frame: At 3 months
Assessed via the Ease of Use, Acceptability, Usefulness, and Safety questionnaire.
At 3 months
Goals of care
Time Frame: At 3 and 6 months
Assessed via Goals of Care. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
At 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kayley Ancy, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-1519
  • NCI-2024-10305 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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