NCT02207556 · OUTCOME
Patient-reported Mental Quality of Life
Doxycycline to Upgrade Organ Response in Light Chain (AL) Amyloidosis Trial · Source last updated 2021-07-09
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
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, 3, 6, 9 and 12 months
What was measured
Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the mental health score. T-scores for this domain range from 21.2 to 67.6. Higher scores indicate poorer mental health.
Analysis population: One subject in the Localized cohort withdrew consent prior to the 6-month visit. Five subjects in the Systemic Disease cohort expired during the course of the study; two subjects came off study; and one was lost to follow-up.
Groups in this outcome
Doxycycline (Localized Disease)
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.
Doxycycline: Doxycycline will be continued until one of the following criteria is met:
* Patient has completed 1 year of doxycycline therapy
* Patient develops any grade 3-4 toxicity related to doxycycline use.
Doxacycline (Systemic Disease)
Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.
Doxycycline: Doxycycline will be continued until one of the following criteria is met:
* Patient has completed 1 year of doxycycline therapy
* Patient develops any grade 3-4 toxicity related to doxycycline use.
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 |
|---|
| Doxycycline (Localized Disease) | 6 |
|---|
| Doxacycline (Systemic Disease) | 25 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Doxycycline (Localized Disease) | 6 |
|---|
| Doxacycline (Systemic Disease) | 25 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Doxycycline (Localized Disease) | 52.1 | 10.4 | Not reported | Not reported | Not reported |
|---|
| Doxacycline (Systemic Disease) | 47.9 | 0.6 | Not reported | Not reported | Not reported |
|---|
3 Month
Analysis denominator · Participants
| Group | Source count |
|---|
| Doxycycline (Localized Disease) | 6 |
|---|
| Doxacycline (Systemic Disease) | 22 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Doxycycline (Localized Disease) | 51.4 | 10.0 | Not reported | Not reported | Not reported |
|---|
| Doxacycline (Systemic Disease) | 46.0 | 0.5 | Not reported | Not reported | Not reported |
|---|
6 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Doxycycline (Localized Disease) | 5 |
|---|
| Doxacycline (Systemic Disease) | 20 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Doxycycline (Localized Disease) | 51.2 | 9.0 | Not reported | Not reported | Not reported |
|---|
| Doxacycline (Systemic Disease) | 46.4 | 0.5 | Not reported | Not reported | Not reported |
|---|
9 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Doxycycline (Localized Disease) | 5 |
|---|
| Doxacycline (Systemic Disease) | 20 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Doxycycline (Localized Disease) | 52.6 | 11.9 | Not reported | Not reported | Not reported |
|---|
| Doxacycline (Systemic Disease) | 46.7 | 0.5 | Not reported | Not reported | Not reported |
|---|
12 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Doxycycline (Localized Disease) | 5 |
|---|
| Doxacycline (Systemic Disease) | 17 |
|---|
Values in score on a scale · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Doxycycline (Localized Disease) | 50.7 | 10.2 | Not reported | Not reported | Not reported |
|---|
| Doxacycline (Systemic Disease) | 50.6 | 0.6 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 10.4
- value
- 52.1
- group Id
- OG001
- spread
- 0.6
- value
- 47.9
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 25
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 10.0
- value
- 51.4
- group Id
- OG001
- spread
- 0.5
- value
- 46.0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 22
- units
- Participants
- title
- 3 Month
- categories
- measurements
- group Id
- OG000
- spread
- 9.0
- value
- 51.2
- group Id
- OG001
- spread
- 0.5
- value
- 46.4
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- 6 Months
- categories
- measurements
- group Id
- OG000
- spread
- 11.9
- value
- 52.6
- group Id
- OG001
- spread
- 0.5
- value
- 46.7
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 20
- units
- Participants
- title
- 9 Months
- categories
- measurements
- group Id
- OG000
- spread
- 10.2
- value
- 50.7
- group Id
- OG001
- spread
- 0.6
- value
- 50.6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 17
- units
- Participants
- title
- 12 Months
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 25
- units
- Participants
- description
- Subjects will complete the Patient Reported Outcomes Measurement Information System Global Health instrument, a 10-item standardized patient-reported outcome measure that provides global ratings of physical function, fatigue, pain, emotional distress to report on common domains of health-related quality of life. The survey comprises a series of 5-response Likert-style questions. For each question, a low score indicates lesser or absent symptom or condition and higher indicates more severe symptom or condition (e.g., 1= None to 5=Very severe). Automated scoring produces a T-score for each domain. This measure reports the mental health score. T-scores for this domain range from 21.2 to 67.6. Higher scores indicate poorer mental health.
- dispersion Type
- Standard Deviation
- groups
- description
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.
Doxycycline: Doxycycline will be continued until one of the following criteria is met:
* Patient has completed 1 year of doxycycline therapy
* Patient develops any grade 3-4 toxicity related to doxycycline use.
- id
- OG000
- title
- Doxycycline (Localized Disease)
- description
- Doxycycline will be administered at dose of 100mg orally twice daily for 1 year.
Doxycycline: Doxycycline will be continued until one of the following criteria is met:
* Patient has completed 1 year of doxycycline therapy
* Patient develops any grade 3-4 toxicity related to doxycycline use.
- id
- OG001
- title
- Doxacycline (Systemic Disease)
- param Type
- MEAN
- population Description
- One subject in the Localized cohort withdrew consent prior to the 6-month visit. Five subjects in the Systemic Disease cohort expired during the course of the study; two subjects came off study; and one was lost to follow-up.
- reporting Status
- POSTED
- time Frame
- Baseline, 3, 6, 9 and 12 months
- title
- Patient-reported Mental Quality of Life
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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