Trial Outcomes & Findings for Understanding What Matters Most to Patients: Establishing the Validity of a Best-Worst Scaling Survey (NCT NCT05061095)

Last Updated: 2024-12-27

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

51 participants

Primary outcome timeframe

3 months after treatment decision

Results posted on

2024-12-27

Participant Flow

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.

A total of fifty-one participants consented and were eligible for the study, but twenty-seven of them started the study interventions.

Participant milestones

Participant milestones
Measure	All Participants Participants who consented to participate.
Overall Study STARTED	51
Overall Study Enrolled and Registered	27
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=51 Participants Participants who consented to participate.
Age, Continuous	71 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants
Primary diagnosis Leukemia	23 Participants n=5 Participants
Primary diagnosis Lymphoma	22 Participants n=5 Participants
Primary diagnosis Multiple Myeloma	2 Participants n=5 Participants
Primary diagnosis Blastic Plasmacytoid Dendritic Cell Neoplasm	1 Participants n=5 Participants
Primary diagnosis Missing	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after treatment decision

Population: Participants with newly-diagnosed hematologic malignancies who completed cognitive interviews.

Outcome measures

Outcome measures
Measure	Qualitative Interviews n=10 Participants Participants (subset of the entire cohort) who completed cognitive interviews to establish the content validity of the BWS survey.
Content Validity of Best-Worst Scaling (BWS) Survey Participants who were able to accurately define each attribute and reported no missing domains.	10 Participants
Content Validity of Best-Worst Scaling (BWS) Survey Participants who could not define attributes or reported missing domains.	0 Participants

SECONDARY outcome

Timeframe: Up to 7 days after treatment decision

Population: Participants with newly-diagnosed hematologic malignancies who completed Best-Worst Scaling (BWS) survey.

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

Outcome measures

Outcome measures
Measure	Qualitative Interviews n=19 Participants Participants (subset of the entire cohort) who completed cognitive interviews to establish the content validity of the BWS survey.
Acceptability of Best-Worst Scaling (BWS) Survey to Patients	13 Participants

SECONDARY outcome

Timeframe: Up to 7 days after treatment decision

Population: Participants with newly-diagnosed hematologic malignancies who completed 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?"

Outcome measures

Outcome measures
Measure	Qualitative Interviews n=19 Participants Participants (subset of the entire cohort) who completed cognitive interviews to establish the content validity of the BWS survey.
Preliminary Efficiency of Best-Worst Scaling (BWS) Survey	9 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: Subjects signed the consent form

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.

Outcome measures

Outcome measures
Measure	Qualitative Interviews n=51 Participants Participants (subset of the entire cohort) who completed cognitive interviews to establish the content validity of the BWS survey.
Completion Rate Over Time consented	51 Participants
Completion Rate Over Time started BWS instrument at baseline	27 Participants
Completion Rate Over Time completed BWS instrument at baseline	26 Participants
Completion Rate Over Time completed study-associated surveys after their treatment encounter at least 1 time	19 Participants
Completion Rate Over Time completed study-associated surveys after their treatment encounter more than 1 time (median 8 times)	16 Participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Daniel Richardson

Lineberger Comprehensive Cancer Center

Phone: (919) 966-4432

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place