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Hematologic NeoplasmsNCT05061095

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

An observational study of Hematologic Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hematologic Neoplasms
What is being tested?
Assessment Surveys and Qualitative Interviews
How many people
51 participants
Where
1 siteUnited States
Study dates
21 Mar 2022to 26 Sep 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 60 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

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.

Being tested
Assessment Surveys, Qualitative Interviews
Keywords
leukemia, lymphoma, myeloma, myelodysplastic syndrome, best-worst scaling survey
Medical subject headings
Hematologic Neoplasms, Leukemia, Lymphoma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment SurveysOther

    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 InterviewsOther

    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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months after treatment decision

Secondary outcomes (3)

  1. Acceptability of Best-Worst Scaling (BWS) Survey to Patients

    Number of patients who respond with agree/strongly agree to "I found survey acceptable to clarify my preferences"

    Measured: Up to 7 days after treatment decision

  2. Preliminary Efficiency of Best-Worst Scaling (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?"

    Measured: Up to 7 days after treatment decision

  3. Completion Rate Over Time

    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.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2021
  2. Study start21 Mar 2022
  3. Primary completion26 Sep 2023
  4. Study completion26 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05061095
Sponsor's protocol ID
LCCC 2136
Other IDs
U2CNR014637
Status last verified
Dec 2024
First submitted
27 Aug 2021
Last updated
27 Dec 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Richardson DR, Crossnohere NL, Seo J, Estey E, O'Donoghue B, Smith BD, Bridges JFP. Age at Diagnosis and Patient Preferences for Treatment Outcomes in AML: A Discrete Choice Experiment to Explore Meaningful Benefits. Cancer Epidemiol Biomarkers Prev. 2020 May;29(5):942-948. doi: 10.1158/1055-9965.EPI-19-1277. Epub 2020 Mar 4.

    PubMed 32132149

  • Richardson DR, Oakes AH, Crossnohere NL, Rathsmill G, Reinhart C, O'Donoghue B, Bridges JFP. Prioritizing the worries of AML patients: Quantifying patient experience using best-worst scaling. Psychooncology. 2021 Jul;30(7):1104-1111. doi: 10.1002/pon.5652. Epub 2021 Feb 27.

    PubMed 33544421

  • Seo J, Smith BD, Estey E, Voyard E, O' Donoghue B, Bridges JFP. Developing an instrument to assess patient preferences for benefits and risks of treating acute myeloid leukemia to promote patient-focused drug development. Curr Med Res Opin. 2018 Dec;34(12):2031-2039. doi: 10.1080/03007995.2018.1456414. Epub 2018 Apr 27.

    PubMed 29565196

  • Bridges JF, Oakes AH, Reinhart CA, Voyard E, O'Donoghue B. Developing and piloting an instrument to prioritize the worries of patients with acute myeloid leukemia. Patient Prefer Adherence. 2018 Apr 27;12:647-655. doi: 10.2147/PPA.S151752. eCollection 2018.

    PubMed 29731612

  • LeBlanc TW, Fish LJ, Bloom CT, El-Jawahri A, Davis DM, Locke SC, Steinhauser KE, Pollak KI. Patient experiences of acute myeloid leukemia: A qualitative study about diagnosis, illness understanding, and treatment decision-making. Psychooncology. 2017 Dec;26(12):2063-2068. doi: 10.1002/pon.4309. Epub 2016 Dec 19.

    PubMed 27862591

  • Loh KP, Abdallah M, Kadambi S, Wells M, Kumar AJ, Mendler JH, Liesveld JL, Wittink M, O'Dwyer K, Becker MW, McHugh C, Stock W, Majhail NS, Wildes TM, Duberstein P, Mohile SG, Klepin HD. Treatment decision-making in acute myeloid leukemia: a qualitative study of older adults and community oncologists. Leuk Lymphoma. 2021 Feb;62(2):387-398. doi: 10.1080/10428194.2020.1832662. Epub 2020 Oct 11.

    PubMed 33040623

  • Rood JAJ, Nauta IH, Witte BI, Stam F, van Zuuren FJ, Manenschijn A, Huijgens PC, Verdonck-de Leeuw IM, Zweegman S. Shared decision-making and providing information among newly diagnosed patients with hematological malignancies and their informal caregivers: Not "one-size-fits-all". Psychooncology. 2017 Dec;26(12):2040-2047. doi: 10.1002/pon.4414. Epub 2017 Apr 17.

    PubMed 28264148

  • El-Jawahri A, Nelson-Lowe M, VanDusen H, Traeger L, Abel GA, Greer JA, Fathi A, Steensma DP, LeBlanc TW, Li Z, DeAngelo D, Wadleigh M, Hobbs G, Foster J, Brunner A, Amrein P, Stone RM, Temel JS. Patient-Clinician Discordance in Perceptions of Treatment Risks and Benefits in Older Patients with Acute Myeloid Leukemia. Oncologist. 2019 Feb;24(2):247-254. doi: 10.1634/theoncologist.2018-0317. Epub 2018 Aug 23.

    PubMed 30139841

  • Richardson DR, Deal AM, Mhina CJ, Washko M, Cole AC, Crossnohere NL, Loh KP, Basch E, Wheeler SB, Wood WA, Bridges JFP, LeBlanc TW, Bennett AV. Developing a Novel Values Elicitation Measure for Clinical Use in Older Adults with Hematologic Malignancies: Values-HM. MDM Policy Pract. 2026 May 7;11(1):23814683261440935. doi: 10.1177/23814683261440935. eCollection 2026 Jan-Jun.

    PubMed 42137489

Questions about this trial

What is this clinical trial studying?

An observational study of Hematologic Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Content Validity of Best-Worst Scaling (BWS) Survey (time frame: 3 months after treatment decision). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05061095, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.

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