TriangleNCT00022633 · OUTCOME
Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- minutes
- Interval / dispersion
- Full Range
- Time frame
- at study entry (prior to administration of any treatment)
What was measured
Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
Analysis population: Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
Groups in this outcome
Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
| Group | Source count |
|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | 50 |
Reported measurements
Medical Conditions Questionnaire
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | 5 | Not reported | 1 | 45 | Not reported |
Instrumental Activities of Daily Living Form
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | 3 | Not reported | 1 | 45 | Not reported |
Feelings Questionnaire
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70) | 2 | Not reported | 1 | 30 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 45
- value
- 5
- title
- Medical Conditions Questionnaire
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 45
- value
- 3
- title
- Instrumental Activities of Daily Living Form
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 30
- value
- 2
- title
- Feelings Questionnaire
- denoms
- counts
- group Id
- OG000
- value
- 50
- units
- Participants
- description
- Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (\> 60%); 2) the number of items missing within each scale (\< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.
- dispersion Type
- Full Range
- groups
- description
- Patients received 1000 mg /m\^2 of gemcitabine on Day 1 and 8 and 175 mg/m\^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
- id
- OG000
- title
- Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)
- param Type
- MEDIAN
- population Description
- Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.
- reporting Status
- POSTED
- time Frame
- at study entry (prior to administration of any treatment)
- title
- Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms
- type
- SECONDARY
- unit Of Measure
- minutes
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice