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

NCT06743308 | Recruiting

• 2 other identifiers: 2024-1519NCI-2024-10305
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Carcinoma; Metastatic Lung Carcinoma; Stage IV Lung Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Change in illness understanding

  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 Outcomes (10)

• Difference between treatment groups in illness understanding

  At 3 and 6 months

• Quality of communication

  At 3 and 6 months

• Feeling heard and understood by healthcare team

  At 3 and 6 months

• Death-related anxiety

  At 3 and 6 months

• Anxiety related symptoms

  At 3 and 6 months

Study Arms (2)

Arm I (Standard care)

ACTIVE COMPARATOR

Patients undergo standard of care oncology follow-up visits.

Other: Best Practice; Other: Questionnaire Administration

Arm II (INPUT screening)

EXPERIMENTAL

Patients complete the INPUT screening tool at each of their standard of care follow up visits, with their medical oncology team.

Other: Best Practice; Other: Questionnaire Administration

Interventions

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

Arm I (Standard care); Arm II (INPUT screening)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Standard care); Arm II (INPUT screening)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kayley Ancy, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayley M Ancy, MD

CONTACT

832-729-1621; kmclemings@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The research staff conducting the outcomes assessment (other than acceptability) will be blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)