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

Sponsor
UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05061095
Collaborator
(none)
50
1
31.4
1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Assessment Surveys
  • Other: Qualitative Interviews

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey
Actual Study Start Date :
Mar 21, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Content validity of Best-Worst Scaling (BWS) survey [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.

Secondary Outcome Measures

  1. Acceptability of BWS survey to patients [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"

  2. Preliminary efficiency of BWS survey [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?"

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Confirmed new diagnosis of one of the following hematologic malignancies: aggressive lymphoma, multiple myeloma, CLL, CML, AML, ALL, MDS EB1 or EB2

  • Ageā‰„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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27514

Sponsors and Collaborators

  • UNC Lineberger Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT05061095
Other Study ID Numbers:
  • LCCC 2136
First Posted:
Sep 29, 2021
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by UNC Lineberger Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2022