TriangleNCT05510908 · OUTCOME
Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- score on a scale between -100 and 100
- Interval / dispersion
- Full Range
- Time frame
- Baseline and 12 weeks
What was measured
EORTC QLQ-C30 will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
Analysis population: Participants who enrolled with EORTC QLQ-C30 measurements for baseline and 12 weeks
Groups in this outcome
New, Primary or Recurrent Disease
Considering or currently receiving cancer treatment Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Metastic or Locally Advanced Cancer
This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies. Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Prior Cancer
Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy. Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
| Group | Source count |
|---|---|
| New, Primary or Recurrent Disease | 82 |
| Metastic or Locally Advanced Cancer | 9 |
| Prior Cancer | 7 |
Reported measurements
Global Health Scale
| Group | Source count |
|---|---|
| New, Primary or Recurrent Disease | 82 |
| Metastic or Locally Advanced Cancer | 9 |
| Prior Cancer | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| New, Primary or Recurrent Disease | 0 | Not reported | -57.1 | 85.7 | Not reported |
| Metastic or Locally Advanced Cancer | 0 | Not reported | -42.9 | 28.6 | Not reported |
| Prior Cancer | 0 | Not reported | -14.3 | 14.3 | Not reported |
Functional Scale
| Group | Source count |
|---|---|
| New, Primary or Recurrent Disease | 77 |
| Metastic or Locally Advanced Cancer | 8 |
| Prior Cancer | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| New, Primary or Recurrent Disease | 1.7 | Not reported | -21.7 | 35 | Not reported |
| Metastic or Locally Advanced Cancer | -2.5 | Not reported | -15 | 38.3 | Not reported |
| Prior Cancer | 0 | Not reported | -1.7 | 3.3 | Not reported |
Symptom Scale
| Group | Source count |
|---|---|
| New, Primary or Recurrent Disease | 76 |
| Metastic or Locally Advanced Cancer | 9 |
| Prior Cancer | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| New, Primary or Recurrent Disease | -1.9 | Not reported | -40.4 | 28.8 | Not reported |
| Metastic or Locally Advanced Cancer | 0 | Not reported | -26.9 | 13.5 | Not reported |
| Prior Cancer | 0 | Not reported | 0 | 3.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -57.1
- upper Limit
- 85.7
- value
- 0
- group Id
- OG001
- lower Limit
- -42.9
- upper Limit
- 28.6
- value
- 0
- group Id
- OG002
- lower Limit
- -14.3
- upper Limit
- 14.3
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Global Health Scale
- categories
- measurements
- group Id
- OG000
- lower Limit
- -21.7
- upper Limit
- 35
- value
- 1.7
- group Id
- OG001
- lower Limit
- -15
- upper Limit
- 38.3
- value
- -2.5
- group Id
- OG002
- lower Limit
- -1.7
- upper Limit
- 3.3
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 77
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Functional Scale
- categories
- measurements
- group Id
- OG000
- lower Limit
- -40.4
- upper Limit
- 28.8
- value
- -1.9
- group Id
- OG001
- lower Limit
- -26.9
- upper Limit
- 13.5
- value
- 0
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 3.8
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 76
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 6
- units
- Participants
- title
- Symptom Scale
- denoms
- counts
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 7
- units
- Participants
- description
- EORTC QLQ-C30 will be summarized, both overall and at the \~12-week follow-up, according to participant characteristics and cancer groups. Overall change in QOL will be compared with paired tests and change according to groups will be compared using t-tests, ANOVA, or nonparametric tests. The EORTC QLQ-C30 is a 30-item core cancer specific questionnaire measuring QOL in cancer patients. It incorporates five functional scales (physical, role,cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and a number of single items assessing additional symptoms and perceived financial impact of the disease. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=higher response level.
- dispersion Type
- Full Range
- groups
- description
- Considering or currently receiving cancer treatment Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
- id
- OG000
- title
- New, Primary or Recurrent Disease
- description
- This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies. Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review. Non-Interventional Follow-up: Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
- id
- OG001
- title
- Metastic or Locally Advanced Cancer
- description
- Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy. Non-Interventional: Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
- id
- OG002
- title
- Prior Cancer
- param Type
- MEDIAN
- population Description
- Participants who enrolled with EORTC QLQ-C30 measurements for baseline and 12 weeks
- reporting Status
- POSTED
- time Frame
- Baseline and 12 weeks
- title
- Change of Quality of Life at 12 Weeks From Baseline for Cancer Patients With HIV Initiating Therapy or Currently Under Treatment Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- score on a scale between -100 and 100
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Preserved source evidence · Not medical advice