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NCT Number: NCT06743308

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Kayley M Ancy, MD

CONTACT

[email protected]

832-729-1621

Kayley M Ancy, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Best Practice

Other

Other Best Practice best practice, standard of care, standard of care, standard of care, standard therapy Undergo standard of care oncology follow-up visits

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Acceptability of screening tool

    Time frame: At 3 months

    Assessed via the Ease of Use, Acceptability, Usefulness, and Safety questionnaire.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kayley M Ancy, MD

CONTACT

[email protected]

832-729-1621

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 19, 2024
Registry last updated
Apr 29, 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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