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OpenTrials
Completed

NCT Number: NCT05061095

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

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.

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Key information

Conditions

Hematologic Neoplasms Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Assessment Surveys

Other

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

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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"

  2. 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?"

  3. 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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2021
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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