Clinical trial NCT06743308: Novel INPUT Screening Tool to Improve Illness Understanding in Patients With Metastatic or Incurable Lung Cancer
Official title: Information Needs, Preferences, and Understanding Trial (INPUT): A Randomized, Controlled Trial of the Effects of a Screening Tool on Illness Understanding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Metastatic Lung Carcinoma
Stage IV Lung Cancer AJCC v8
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Change in illness understanding
timeFrame: At 3 months
Secondary outcomes:
measure: Difference between treatment groups in illness understanding
timeFrame: At 3 and 6 months
measure: Quality of communication
timeFrame: At 3 and 6 months
measure: Feeling heard and understood by healthcare team
timeFrame: At 3 and 6 months
measure: Death-related anxiety
timeFrame: At 3 and 6 months
measure: Anxiety related symptoms
timeFrame: At 3 and 6 months
measure: Depression
timeFrame: At 3 and 6 months
measure: Health related quality of life
timeFrame: At 3 and 6 months
measure: Symptoms of advanced cancer
timeFrame: At 3 and 6 months
measure: Acceptability of screening tool
timeFrame: At 3 months
measure: Goals of care
timeFrame: At 3 and 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Kayley Ancy, MD
role: PRINCIPAL_INVESTIGATOR
References: