Information Needs, Preferences, and Understanding Trial (INPUT): A Randomized, Controlled Trial of the Effects of a Screening Tool on Illness Understanding
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Change in illness understanding
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Masking Description
The research staff conducting the outcomes assessment (other than acceptability) will be blinded to group assignment.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Questionnaire Administration (Other)
Arm I (Standard care)
Patients undergo standard of care oncology follow-up visits.
Intervention: Best Practice (Other)
Arm I (Standard care)
Patients undergo standard of care oncology follow-up visits.
Intervention: Questionnaire Administration (Other)
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.
Intervention: Best Practice (Other)
Outcomes
Primary Outcomes
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
- 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)
- Depression(At 3 and 6 months)
- Health related quality of life(At 3 and 6 months)
- Symptoms of advanced cancer(At 3 and 6 months)
- Acceptability of screening tool(At 3 months)
- Goals of care(At 3 and 6 months)