Hematologic Neoplasms
Conditions
Keywords
leukemia, lymphoma, myeloma, myelodysplastic syndrome, best-worst scaling survey
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.
Interventions
OTHERAssessment 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.
OTHERQualitative 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.
Sponsors
National Institute of Nursing Research (NINR)
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Best-Worst Scaling (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 |
| Preliminary Efficiency of Best-Worst Scaling (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? |
| Completion Rate Over Time | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 03/21/2022 through 06/29/2023 at one cancer center, in North Carolina. Subjects were enrolled in the study between 03/31/2022 through 06/29/2023.
Pre-assignment details
A total of fifty-one participants consented and were eligible for the study, but twenty-seven of them started the study interventions.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants who consented to participate. | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 71 years |
| Primary diagnosis Blastic Plasmacytoid Dendritic Cell Neoplasm | 1 Participants |
| Primary diagnosis Leukemia | 23 Participants |
| Primary diagnosis Lymphoma | 22 Participants |
| Primary diagnosis Missing | 3 Participants |
| Primary diagnosis Multiple Myeloma | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: 3 months after treatment decision
Population: Participants with newly-diagnosed hematologic malignancies who completed cognitive interviews.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Qualitative Interviews | Content Validity of Best-Worst Scaling (BWS) Survey | Participants who were able to accurately define each attribute and reported no missing domains. | 10 Participants |
| Qualitative Interviews | Content Validity of Best-Worst Scaling (BWS) Survey | Participants who could not define attributes or reported missing domains. | 0 Participants |
Secondary
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
Time frame: Up to 7 days after treatment decision
Population: Participants with newly-diagnosed hematologic malignancies who completed Best-Worst Scaling (BWS) survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Qualitative Interviews | Acceptability of Best-Worst Scaling (BWS) Survey to Patients | 13 Participants |
Secondary
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.
Time frame: Up to 1 year
Population: Subjects signed the consent form
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Qualitative Interviews | Completion Rate Over Time | consented | 51 Participants |
| Qualitative Interviews | Completion Rate Over Time | started BWS instrument at baseline | 27 Participants |
| Qualitative Interviews | Completion Rate Over Time | completed BWS instrument at baseline | 26 Participants |
| Qualitative Interviews | Completion Rate Over Time | completed study-associated surveys after their treatment encounter at least 1 time | 19 Participants |
| Qualitative Interviews | Completion Rate Over Time | completed study-associated surveys after their treatment encounter more than 1 time (median 8 times) | 16 Participants |
Secondary
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?
Time frame: Up to 7 days after treatment decision
Population: Participants with newly-diagnosed hematologic malignancies who completed survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Qualitative Interviews | Preliminary Efficiency of Best-Worst Scaling (BWS) Survey | 9 Participants |