TriangleNCT05061095 · REGISTRY CONDITION SEARCH
Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- COMPLETED
- Registry last update
- 2024-12-27
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- eligibility Criteria
- 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).
- minimum Age
- 60 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
- study Population
- Participants are older (≥60) patients with newly-diagnosed hematological malignancies.
Treatment arms and interventions
- interventions
- description
- 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.
- name
- Assessment Surveys
- type
- OTHER
- description
- 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.
- name
- Qualitative Interviews
- type
- OTHER
Study design
- observational Model
- COHORT
- time Perspective
- PROSPECTIVE
Enrollment
- count
- 51
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Content Validity of Best-Worst Scaling (BWS) Survey
- time Frame
- 3 months after treatment decision
- secondary Outcomes
- description
- Number of patients who respond with agree/strongly agree to "I found survey acceptable to clarify my preferences"
- measure
- Acceptability of Best-Worst Scaling (BWS) Survey to Patients
- time Frame
- Up to 7 days after treatment decision
- description
- 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?"
- measure
- Preliminary Efficiency of Best-Worst Scaling (BWS) Survey
- time Frame
- Up to 7 days after treatment decision
- description
- 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.
- measure
- Completion Rate Over Time
- time Frame
- Up to 1 year
Full 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.
Source references
- references
- citation
- 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.
- pmid
- 32132149
- type
- BACKGROUND
- citation
- 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.
- pmid
- 33544421
- type
- BACKGROUND
- citation
- 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.
- pmid
- 29565196
- type
- BACKGROUND
- citation
- 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.
- pmid
- 29731612
- type
- BACKGROUND
- citation
- 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.
- pmid
- 27862591
- type
- BACKGROUND
- citation
- 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.
- pmid
- 33040623
- type
- BACKGROUND
- citation
- 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.
- pmid
- 28264148
- type
- BACKGROUND
- citation
- 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.
- pmid
- 30139841
- type
- BACKGROUND
- citation
- 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.
- pmid
- 42137489
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice