Lung CarcinomaNCT06743308
Novel INPUT Screening Tool to Improve Illness Understanding in Patients With Metastatic or Incurable Lung Cancer
A study testing Best Practice and Questionnaire Administration in people with Lung Carcinoma and Metastatic Lung Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Carcinoma, Metastatic Lung Carcinoma, Stage IV Lung Cancer AJCC v8
- What is being tested?
- Best Practice and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of cognitive impairment or dementia requiring a surrogate decision maker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Kayley M Ancy, MD, 832-729-1621, kmclemings@mdanderson.org
Kayley M Ancy, MD
About this study
Official title: Information Needs, Preferences, and Understanding Trial (INPUT): A Randomized, Controlled Trial of the Effects of a Screening Tool on Illness Understanding
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.
Read the 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.
- Being tested
- Best Practice, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
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 AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Standard care) | Active comparator | Patients undergo standard of care oncology follow-up visits. Receives: 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. Receives: Other: Best Practice; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 3 months
Secondary outcomes (10)
Difference between treatment groups in illness understanding
Based upon the Prigerson Measure of Illness Understanding. The Likert-scale and composite score responses (excluding the acceptability of screening tool assessment) will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts.
Measured: At 3 and 6 months
Quality of communication
Assessed via the Quality of Communication questionnaire. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Feeling heard and understood by healthcare team
Assessed via the Feeling Heard and Understood scale. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Death-related anxiety
Assessed via the Death and Dying Distress scale. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Anxiety related symptoms
Assessed via the Generalized Anxiety Disorder scale. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Depression
Assessed via the Patient Health Questionnaire, 9 items. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Health related quality of life
Assessed via the Functional Assessment of Cancer Therapy - General. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Symptoms of advanced cancer
Assessed via the Edmonton Symptom Assessment System. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Acceptability of screening tool
Assessed via the Ease of Use, Acceptability, Usefulness, and Safety questionnaire.
Measured: At 3 months
Goals of care
Assessed via Goals of Care. The Likert-scale and composite score responses will be modeled by mixed-effect analysis of variance with relation to treatment group and time point, with interaction. Change from baseline at each time point will be assessed by contrasts, without adjustment for multiple comparisons since this is a pilot study. Baseline variables which show evidence of differences may be utilized as model covariates to control for associated bias. Binary responses (including the primary objective) will be similarly modeled by mixed-effect logistic regression. Survey responses which are neither Likert, composite, nor binary, may have categories collapsed such that they can be analyzed as binary.
Measured: At 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start16 Dec 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kayley Ancy, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743308
- Sponsor's protocol ID
- 2024-1519
- Other IDs
- NCI-2024-10305
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No