NCT03951220 · OUTCOME
Secondary Outcome 4: Assess Participants' Experience of Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) Scans The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss · Source last updated 2025-08-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure MEAN
Unit Score on a scale (see description above)
Interval / dispersion Standard Deviation
Time frame At baseline and six months What was measured This questionnaire assesses the experience of the Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) scans. Answers were recorded on a 5 point Likert scale where the lower number represents a better outcome.
Scale descriptors:
Q1 (Overall Experience): 1 (Very comfortable)/ 2 (Comfortable)/ 3 (Neither comfortable or uncomfortable)/ 4 (Uncomfortable)/ 5 (Very uncomfortable) Q2 (Adverse Effects): 1 (YES) / 0 (NO) Q3 (Length of Time): 0 (Too short) / 1 (Just right) / 2 (Too long) Q4 (Pain/Discomfort): 1 (No Increase)/ 2 (Mild Increase)/ 3 (Moderate Increase)/ 4 (High Increase)/ 5 (Severe Increase) Q5 (Likely to Reparticipate): 0 (Extremely Unlikely) / 1 (Unlikely) / 2 (Neither Likely or Unlikely) / 3 (Likely) / 4 (Extremely Likely) Q6 (How similar to expectations): 1 (YES) / 0 (NO) Q7 (Comfort with Staff): 1 (YES) / 0 (NO)
Analysis population: Baseline: all participants from Groups 1,2,3 were invited for novel MR scan, and only participants from Groups 1 and 2 were invited for DXA Follow-up: only participants from Groups 1 and 2 were invited for a novel MR scan and also a DXA.
Groups in this outcome Group 1- Myeloma Participants recruited with myeloma
Group 2- MGUS Participants recruited with MGUS
Group 3- Healthy Volunteers Participants recruited as healthy volunteers
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 14 Group 3- Healthy Volunteers 12
Reported measurements Baseline novel MR scan experience: Q1 = Overall Experience Analysis denominator · Participants
Group Source count Group 1- Myeloma 38 Group 2- MGUS 13 Group 3- Healthy Volunteers 12
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 2.10 0.91 Not reported Not reported Not reported Group 2- MGUS 2.10 0.93 Not reported Not reported Not reported Group 3- Healthy Volunteers 2.13 0.92 Not reported Not reported Not reported
Baseline novel MR scan experience: Q2 = Adverse Effects Analysis denominator · Participants
Group Source count Group 1- Myeloma 39 Group 2- MGUS 13 Group 3- Healthy Volunteers 11
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 0.30 0.46 Not reported Not reported Not reported Group 2- MGUS 0.31 0.47 Not reported Not reported Not reported Group 3- Healthy Volunteers 0.33 0.47 Not reported Not reported Not reported
Baseline novel MR scan experience: Q3 = Length of Time Analysis denominator · Participants
Group Source count Group 1- Myeloma 37 Group 2- MGUS 12 Group 3- Healthy Volunteers 10
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.39 0.49 Not reported Not reported Not reported Group 2- MGUS 1.40 0.49 Not reported Not reported Not reported Group 3- Healthy Volunteers 1.40 0.50 Not reported Not reported Not reported
Baseline novel MR scan experience: Q4 = Pain/Discomfort Analysis denominator · Participants
Group Source count Group 1- Myeloma 36 Group 2- MGUS 13 Group 3- Healthy Volunteers 11
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.75 0.86 Not reported Not reported Not reported Group 2- MGUS 1.74 0.87 Not reported Not reported Not reported Group 3- Healthy Volunteers 1.73 0.89 Not reported Not reported Not reported
Baseline novel MR scan experience: Q5 = How Likely to Re-participate Analysis denominator · Participants
Group Source count Group 1- Myeloma 37 Group 2- MGUS 13 Group 3- Healthy Volunteers 11
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 3.34 0.91 Not reported Not reported Not reported Group 2- MGUS 3.36 0.92 Not reported Not reported Not reported Group 3- Healthy Volunteers 3.34 0.96 Not reported Not reported Not reported
Baseline novel MR scan experience: Q6 = How Similar to Expectations Analysis denominator · Participants
Group Source count Group 1- Myeloma 36 Group 2- MGUS 13 Group 3- Healthy Volunteers 11
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 0.00 Not reported Not reported Not reported Group 2- MGUS 1.00 0.00 Not reported Not reported Not reported Group 3- Healthy Volunteers 1.00 0.00 Not reported Not reported Not reported
Baseline novel MR scan experience: Q7 = Comfort with Staff Analysis denominator · Participants
Group Source count Group 1- Myeloma 37 Group 2- MGUS 13 Group 3- Healthy Volunteers 11
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 0.00 Not reported Not reported Not reported Group 2- MGUS 1.00 0.00 Not reported Not reported Not reported Group 3- Healthy Volunteers 1.00 0.00 Not reported Not reported Not reported
Follow-up novel MR scan experience: Q1 = Overall Experience Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 2.17 1.07 Not reported Not reported Not reported Group 2- MGUS 2.20 1.11 Not reported Not reported Not reported
Follow-up novel MR scan experience: Q2 = Adverse Effects Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 0.27 0.45 Not reported Not reported Not reported Group 2- MGUS 0.28 0.45 Not reported Not reported Not reported
Follow-up novel MR scan experience: Q3 = Length of Time Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 9 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.30 0.46 Not reported Not reported Not reported Group 2- MGUS 1.33 0.48 Not reported Not reported Not reported
Follow-up novel MR scan experience: Q4 = Pain/Discomfort Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.44 0.71 Not reported Not reported Not reported Group 2- MGUS 1.48 0.82 Not reported Not reported Not reported
Follow-up novel MR scan experience: Q5 = How Likely to Re-participate Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 3.29 1.05 Not reported Not reported Not reported Group 2- MGUS 3.33 1.05 Not reported Not reported Not reported
Follow-up novel MR scan experience: Q6 = How Similar to Expectations Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 0.00 Not reported Not reported Not reported Group 2- MGUS 1.00 0.00 Not reported Not reported Not reported
Follow-up novel MR scan experience: Q7 = Comfort with Staff Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 0.00 Not reported Not reported Not reported Group 2- MGUS 0.98 0.16 Not reported Not reported Not reported
Baseline DXA scan experience: Q1 = Overall Experience Analysis denominator · Participants
Group Source count Group 1- Myeloma 40 Group 2- MGUS 13 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.58 0.72 Not reported Not reported Not reported Group 2- MGUS 1.61 0.72 Not reported Not reported Not reported
Baseline DXA scan experience: Q2 = Adverse Effects Analysis denominator · Participants
Group Source count Group 1- Myeloma 40 Group 2- MGUS 13 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 0.11 0.32 Not reported Not reported Not reported Group 2- MGUS 0.12 0.33 Not reported Not reported Not reported
Baseline DXA scan experience: Q3 = Length of Time Analysis denominator · Participants
Group Source count Group 1- Myeloma 39 Group 2- MGUS 13 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 0.00 Not reported Not reported Not reported Group 2- MGUS 1.00 0.00 Not reported Not reported Not reported
Baseline DXA scan experience: Q4 = Pain/Discomfort Analysis denominator · Participants
Group Source count Group 1- Myeloma 40 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.17 0.43 Not reported Not reported Not reported Group 2- MGUS 1.16 0.42 Not reported Not reported Not reported
Baseline DXA scan experience: Q5 = How Likely to Re-participate Analysis denominator · Participants
Group Source count Group 1- Myeloma 40 Group 2- MGUS 13 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 3.51 0.85 Not reported Not reported Not reported Group 2- MGUS 3.53 0.83 Not reported Not reported Not reported
Baseline DXA scan experience: Q6 = How Similar to Expectations Analysis denominator · Participants
Group Source count Group 1- Myeloma 38 Group 2- MGUS 13 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 0.98 0.14 Not reported Not reported Not reported Group 2- MGUS 0.98 0.14 Not reported Not reported Not reported
Baseline DXA scan experience: Q7 = Comfort with Staff Analysis denominator · Participants
Group Source count Group 1- Myeloma 39 Group 2- MGUS 13 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 0.00 Not reported Not reported Not reported Group 2- MGUS 1.00 0.00 Not reported Not reported Not reported
Follow-up DXA scan experience: Q1 = Overall Experience Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.65 0.75 Not reported Not reported Not reported Group 2- MGUS 1.71 0.83 Not reported Not reported Not reported
Follow-up DXA scan experience: Q2 = Adverse Effects Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 0.09 0.29 Not reported Not reported Not reported Group 2- MGUS 0.10 0.30 Not reported Not reported Not reported
Follow-up DXA scan experience: Q3 = Length of Time Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.05 0.21 Not reported Not reported Not reported Group 2- MGUS 1.07 0.26 Not reported Not reported Not reported
Follow-up DXA scan experience: Q4 = Pain/Discomfort Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.12 0.32 Not reported Not reported Not reported Group 2- MGUS 1.19 0.55 Not reported Not reported Not reported
Follow-up DXA scan experience: Q5 = How Likely to Re-participate Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 3.63 0.85 Not reported Not reported Not reported Group 2- MGUS 3.67 0.85 Not reported Not reported Not reported
Follow-up DXA scan experience: Q6 = How Similar to Expectations Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 1.00 Not reported Not reported Not reported Group 2- MGUS 1.00 0.00 Not reported Not reported Not reported
Follow-up DXA scan experience: Q7 = Comfort with Staff Analysis denominator · Participants
Group Source count Group 1- Myeloma 41 Group 2- MGUS 12 Group 3- Healthy Volunteers 0
Values in Score on a scale (see description above) · Interval/dispersion: Standard Deviation Group Value Spread Lower Upper Comment Group 1- Myeloma 1.00 1.00 Not reported Not reported Not reported Group 2- MGUS 0.98 0.15 Not reported Not reported Not reported
Complete source fields classes categories measurements
group Id OG000
spread 0.91
value 2.10
group Id OG001
spread 0.93
value 2.10
group Id OG002
spread 0.92
value 2.13 denoms counts
group Id OG000
value 38
group Id OG001
value 13
group Id OG002
value 12
units Participants
title Baseline novel MR scan experience: Q1 = Overall Experience categories measurements
group Id OG000
spread 0.46
value 0.30
group Id OG001
spread 0.47
value 0.31
group Id OG002
spread 0.47
value 0.33 denoms counts
group Id OG000
value 39
group Id OG001
value 13
group Id OG002
value 11
units Participants
title Baseline novel MR scan experience: Q2 = Adverse Effects categories measurements
group Id OG000
spread 0.49
value 1.39
group Id OG001
spread 0.49
value 1.40
group Id OG002
spread 0.50
value 1.40 denoms counts
group Id OG000
value 37
group Id OG001
value 12
group Id OG002
value 10
units Participants
title Baseline novel MR scan experience: Q3 = Length of Time categories measurements
group Id OG000
spread 0.86
value 1.75
group Id OG001
spread 0.87
value 1.74
group Id OG002
spread 0.89
value 1.73 denoms counts
group Id OG000
value 36
group Id OG001
value 13
group Id OG002
value 11
units Participants
title Baseline novel MR scan experience: Q4 = Pain/Discomfort categories measurements
group Id OG000
spread 0.91
value 3.34
group Id OG001
spread 0.92
value 3.36
group Id OG002
spread 0.96
value 3.34 denoms counts
group Id OG000
value 37
group Id OG001
value 13
group Id OG002
value 11
units Participants
title Baseline novel MR scan experience: Q5 = How Likely to Re-participate categories measurements
group Id OG000
spread 0.00
value 1.00
group Id OG001
spread 0.00
value 1.00
group Id OG002
spread 0.00
value 1.00 denoms counts
group Id OG000
value 36
group Id OG001
value 13
group Id OG002
value 11
units Participants
title Baseline novel MR scan experience: Q6 = How Similar to Expectations categories measurements
group Id OG000
spread 0.00
value 1.00
group Id OG001
spread 0.00
value 1.00
group Id OG002
spread 0.00
value 1.00 denoms counts
group Id OG000
value 37
group Id OG001
value 13
group Id OG002
value 11
units Participants
title Baseline novel MR scan experience: Q7 = Comfort with Staff categories measurements
group Id OG000
spread 1.07
value 2.17
group Id OG001
spread 1.11
value 2.20 denoms counts
group Id OG000
value 41
group Id OG001
value 12
group Id OG002
value 0
units Participants
title Follow-up novel MR scan experience: Q1 = Overall Experience categories measurements
group Id OG000
spread 0.45
value 0.27
group Id OG001
spread 0.45
value 0.28 denoms counts
group Id OG000
value 41
group Id OG001
value 12
group Id OG002
value 0
units Participants
title Follow-up novel MR scan experience: Q2 = Adverse Effects categories measurements
group Id OG000
spread 0.46
value 1.30
group Id OG001
spread 0.48
value 1.33 denoms counts
group Id OG000
value 41
group Id OG001
value 9
group Id OG002
value 0
units Participants
title Follow-up novel MR scan experience: Q3 = Length of Time categories measurements
group Id OG000
spread 0.71
value 1.44
group Id OG001
spread 0.82
value 1.48 denoms counts
group Id OG000
value 41
group Id OG001
value 12
group Id OG002
value 0
units Participants
title Follow-up novel MR scan experience: Q4 = Pain/Discomfort categories measurements
group Id OG000
spread 1.05
value 3.29
group Id OG001
spread 1.05
value 3.33 denoms counts
group Id OG000
value 41
group Id OG001
value 12
group Id OG002
value 0
units Participants
title Follow-up novel MR scan experience: Q5 = How Likely to Re-participate Show more (12 of 28) denoms counts
group Id OG000
value 41
group Id OG001
value 14
group Id OG002
value 12
units Participants
description This questionnaire assesses the experience of the Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) scans. Answers were recorded on a 5 point Likert scale where the lower number represents a better outcome.
Scale descriptors:
Q1 (Overall Experience): 1 (Very comfortable)/ 2 (Comfortable)/ 3 (Neither comfortable or uncomfortable)/ 4 (Uncomfortable)/ 5 (Very uncomfortable) Q2 (Adverse Effects): 1 (YES) / 0 (NO) Q3 (Length of Time): 0 (Too short) / 1 (Just right) / 2 (Too long) Q4 (Pain/Discomfort): 1 (No Increase)/ 2 (Mild Increase)/ 3 (Moderate Increase)/ 4 (High Increase)/ 5 (Severe Increase) Q5 (Likely to Reparticipate): 0 (Extremely Unlikely) / 1 (Unlikely) / 2 (Neither Likely or Unlikely) / 3 (Likely) / 4 (Extremely Likely) Q6 (How similar to expectations): 1 (YES) / 0 (NO) Q7 (Comfort with Staff): 1 (YES) / 0 (NO)
dispersion Type Standard Deviation groups
description Participants recruited with myeloma
id OG000
title Group 1- Myeloma
description Participants recruited with MGUS
id OG001
title Group 2- MGUS
description Participants recruited as healthy volunteers
id OG002
title Group 3- Healthy Volunteers
param Type MEAN
population Description Baseline: all participants from Groups 1,2,3 were invited for novel MR scan, and only participants from Groups 1 and 2 were invited for DXA Follow-up: only participants from Groups 1 and 2 were invited for a novel MR scan and also a DXA.
reporting Status POSTED
time Frame At baseline and six months
title Secondary Outcome 4: Assess Participants' Experience of Novel Magnetic Resonance (MR) and Dual-energy X-ray Absorptiometry (DXA) Scans
type SECONDARY
unit Of Measure Score on a scale (see description above) Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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