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

December 2, 2024 updated by: UNC Lineberger Comprehensive Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Lineberger Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants are older (≥60) patients with newly-diagnosed hematological malignancies.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pilot Testing: Aggressive Lymphoma
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
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.
Pilot Testing: Acute Leukemia
20 patients diagnosed with acute leukemias participating in the questionnaire portion of the study.
Other: Assessment Surveys
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.
Pilot Testing: Myeloma/CLL/CML
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
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.
Qualitative Interviews: Living Longer
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
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.
Qualitative Interviews: Other
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Content Validity of Best-Worst Scaling (BWS) Survey
Time Frame: 3 months after treatment decision
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 Best-Worst Scaling (BWS) Survey to Patients
Time Frame: Up to 7 days after treatment decision
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 Best-Worst Scaling (BWS) Survey
Time Frame: Up to 7 days after treatment decision
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
Completion Rate Over Time
Time Frame: Up to 1 year
The completion rate over time will be reported by the number of patients who complete the BWS survey at each time point, in 3 months intervals.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Daniel Richardson, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2022

Primary Completion (Actual)

September 26, 2023

Study Completion (Actual)

September 26, 2023

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 17, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC 2136
  • U2CNR014637 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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