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

NCT ID: NCT06743308

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-16

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Carcinoma Metastatic Lung Carcinoma Stage IV Lung Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

The research staff conducting the outcomes assessment (other than acceptability) will be blinded to group assignment.

Study Groups

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Arm I (Standard care)

Patients undergo standard of care oncology follow-up visits.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type 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

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type 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

Intervention Type OTHER

Ancillary studies

Interventions

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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

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kayley Ancy, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kayley M Ancy, MD

Role: CONTACT

832-729-1621

Facility Contacts

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Kayley M Ancy, MD

Role: primary

832-729-1621

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2024-10305

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1519

Identifier Type: -

Identifier Source: org_study_id

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