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Recruiting NCT06743308

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

No phase Interventional Lung Carcinoma Metastatic Lung Carcinoma Stage IV Lung Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Lung Carcinoma, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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
  • Other Questionnaire Administration
    Ancillary studies

Primary outcome measures

  • Change in illness understanding [Time frame: At 3 months]
Secondary outcome measures (10)
  • Difference between treatment groups in illness understanding [Time frame: At 3 and 6 months]
  • Quality of communication [Time frame: At 3 and 6 months]
  • Feeling heard and understood by healthcare team [Time frame: At 3 and 6 months]
  • Death-related anxiety [Time frame: At 3 and 6 months]
  • Anxiety related symptoms [Time frame: At 3 and 6 months]
  • Depression [Time frame: At 3 and 6 months]
  • Health related quality of life [Time frame: At 3 and 6 months]
  • Symptoms of advanced cancer [Time frame: At 3 and 6 months]
  • Acceptability of screening tool [Time frame: At 3 months]
  • Goals of care [Time frame: At 3 and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06743308 · 2024-1519 · NCI-2024-10305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗