Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey

Study Overview
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Brief Summary
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This study will evaluate the validity of using a survey to quantify patient preferences at the point-of-care and the potential effectiveness of the survey to improve goal-concordant care. The primary hypothesis is that by identifying the strength of patient preferences for outcomes with this survey clinicians will be able to improve goal-concordant care by aligning clinical recommendations with patients' preferences. This study will have 50 patients with newly diagnosed hematologic malignancy complete the survey throughout their disease course (up to 2 years) and conduct qualitative interviews with a subset (n = 20) of participants. The information obtained from these participants will be used to refine the survey. Interviews with oncologists and palliative care specialists (up to 10) will inform implementation.

Official Title
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Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey

Conditions
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Hematologic Neoplasms

Intervention / Treatment
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* Other: Assessment Surveys
* Other: Qualitative Interviews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed new diagnosis of one of the following hematologic malignancies: aggressive lymphoma, multiple myeloma, CLL, CML, AML, ALL, MDS EB1 or EB2 Age≥60 Ability to read, understand, and communicate fluently in English Ability to understand and comply with study procedures Willingness and ability to provide written informed consent Exclusion Criteria: Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the discrete choice experiment. Significant medical conditions, as assessed by the investigators, that would substantially increase the burden on the patient to complete study assessments (such as multiorgan failure, respiratory failure, or other critical illness).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilot Testing: Aggressive Lymphoma<br>20 patients diagnosed with aggressive lymphomas (e.g. diffuse large B-cell, advanced Hodgkin's) participating in the questionnaire portion of the study. | Other: Assessment Surveys<br>* Patients will complete surveys in three periods. An initial baseline survey, longitudinal assessments completed every 2 weeks over the course of the first three months on study (6 times maximum), and extended assessments that will happen every 3 months after the initial longitudinal period up to 2 years on the study (7 times maximum). Baseline questionnaire will collect demographic and background medical record information. Longitudinal assessments will consist of a BWS questionnaire (patients rate importance of 7 treatment goals), decisional conflict scales, EQ-5D-5L, distress thermometer, and items from PRO-CTCAE. Extended assessments will use same questionnaires as longitudinal assessments.<br>|
| Pilot Testing: Acute Leukemia<br>20 patients diagnosed with acute leukemias participating in the questionnaire portion of the study. | Other: Assessment Surveys<br>* Patients will complete surveys in three periods. An initial baseline survey, longitudinal assessments completed every 2 weeks over the course of the first three months on study (6 times maximum), and extended assessments that will happen every 3 months after the initial longitudinal period up to 2 years on the study (7 times maximum). Baseline questionnaire will collect demographic and background medical record information. Longitudinal assessments will consist of a BWS questionnaire (patients rate importance of 7 treatment goals), decisional conflict scales, EQ-5D-5L, distress thermometer, and items from PRO-CTCAE. Extended assessments will use same questionnaires as longitudinal assessments.<br>|
| Pilot Testing: Myeloma/CLL/CML<br>10 patients diagnosed with either myelomas, chronic lymphocytic leukemia, or chronic myeloid leukemia that are participating in the questionnaire portion of the study. | Other: Assessment Surveys<br>* Patients will complete surveys in three periods. An initial baseline survey, longitudinal assessments completed every 2 weeks over the course of the first three months on study (6 times maximum), and extended assessments that will happen every 3 months after the initial longitudinal period up to 2 years on the study (7 times maximum). Baseline questionnaire will collect demographic and background medical record information. Longitudinal assessments will consist of a BWS questionnaire (patients rate importance of 7 treatment goals), decisional conflict scales, EQ-5D-5L, distress thermometer, and items from PRO-CTCAE. Extended assessments will use same questionnaires as longitudinal assessments.<br>|
| Qualitative Interviews: Living Longer<br>10 participants (subset of the three pilot testing cohorts) that designate in their questionnaires that living longer is the most important outcome for them. | Other: Qualitative Interviews<br>* Patients will participate in 2 interviews (1 initial interview, 1 follow up). These will be cognitive interviews focusing on establishing content validity for BWS questionnaire. Will establish patient understanding of questions asked in BWS, understanding of how preferences affect treatment decisions, expected outcomes, and feedback from patients on other potentially important attributes not included in BWS.<br>|
| Qualitative Interviews: Other<br>10 participants (subset of the three pilot testing cohorts) that designate in their questionnaires that any other outcome besides living longer is the most important. | Other: Qualitative Interviews<br>* Patients will participate in 2 interviews (1 initial interview, 1 follow up). These will be cognitive interviews focusing on establishing content validity for BWS questionnaire. Will establish patient understanding of questions asked in BWS, understanding of how preferences affect treatment decisions, expected outcomes, and feedback from patients on other potentially important attributes not included in BWS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Content validity of Best-Worst Scaling (BWS) survey | Cognitive interviewing will be used to evaluate the content validity of using a BWS survey to quantify the preferences of older patients with hematologic malignancies at the point-of-care. BWS survey asks patients a series of questions where they choose one attribute as best and one as worst - the 7 included in this survey are maintaining usual activities, living longer, avoiding dependence on others, avoiding short-term side effects, avoiding long-term side effects, avoiding hospitalizations, and avoiding high out-of-pocket costs. | 3 months after treatment decision | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of BWS survey to patients | Number of patients who respond with agree/strongly agree to I found survey acceptable to clarify my preferences | Up to 7 days after treatment decision | 
| Preliminary efficiency of BWS survey | Number of patients who respond moderately effective/very affective to how effective was the survey to help you and your doctor choose a treatment that was consistent with your goals? | Up to 7 days after treatment decision | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leukemia, lymphoma, myeloma, myelodysplastic syndrome, best-worst scaling survey