TriangleNCT02589938 · OUTCOME
Functional Assessment of Cancer Therapy (FACT-G) Total
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale 0-108
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline, 4 , 8 , 12, and 26 weeks
What was measured
The FACT-G QOL instrument discriminates between individuals with metastatic and non-metastatic disease, as well as between patients at different stages of illness. The scale has good concurrent validity, high internal consistency (0.89), and good test-re-test reliability (0.82 to 0.88). The total score is reported, which is a combination of the subscales of physical, social/family, emotional, and functional well-being, with higher scores representing better QOL. Scale range 0-108
Analysis population: Intent to treat analysis. Considered and utilized all data available at each timepoint.
Groups in this outcome
Standard Oral Hygiene
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.
Standard Oral Hygiene + True Acupuncture
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
Standard Oral Hygiene + Sham Acupuncture
All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
| Group | Source count |
|---|---|
| Standard Oral Hygiene | 86 |
| Standard Oral Hygiene + True Acupuncture | 86 |
| Standard Oral Hygiene + Sham Acupuncture | 86 |
Reported measurements
Week 4
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 97.7 | Not reported | 95.8 | 99.6 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 101.6 | Not reported | 100.0 | 103.2 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 100.1 | Not reported | 98.4 | 101.8 | Not reported |
Week 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 99.5 | Not reported | 97.4 | 101.6 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 101.1 | Not reported | 99.1 | 103.2 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 100.1 | Not reported | 98.2 | 102.1 | Not reported |
Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 97.4 | Not reported | 95.5 | 99.4 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 102.1 | Not reported | 100.3 | 103.8 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 98.4 | Not reported | 96.6 | 100.2 | Not reported |
Week 26
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Standard Oral Hygiene | 98.7 | Not reported | 96.2 | 101.1 | Not reported |
| Standard Oral Hygiene + True Acupuncture | 100.5 | Not reported | 98.2 | 102.7 | Not reported |
| Standard Oral Hygiene + Sham Acupuncture | 100.1 | Not reported | 97.8 | 102.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 95.8
- upper Limit
- 99.6
- value
- 97.7
- group Id
- OG001
- lower Limit
- 100.0
- upper Limit
- 103.2
- value
- 101.6
- group Id
- OG002
- lower Limit
- 98.4
- upper Limit
- 101.8
- value
- 100.1
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 97.4
- upper Limit
- 101.6
- value
- 99.5
- group Id
- OG001
- lower Limit
- 99.1
- upper Limit
- 103.2
- value
- 101.1
- group Id
- OG002
- lower Limit
- 98.2
- upper Limit
- 102.1
- value
- 100.1
- title
- Week 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 95.5
- upper Limit
- 99.4
- value
- 97.4
- group Id
- OG001
- lower Limit
- 100.3
- upper Limit
- 103.8
- value
- 102.1
- group Id
- OG002
- lower Limit
- 96.6
- upper Limit
- 100.2
- value
- 98.4
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- lower Limit
- 96.2
- upper Limit
- 101.1
- value
- 98.7
- group Id
- OG001
- lower Limit
- 98.2
- upper Limit
- 102.7
- value
- 100.5
- group Id
- OG002
- lower Limit
- 97.8
- upper Limit
- 102.4
- value
- 100.1
- title
- Week 26
- denoms
- counts
- group Id
- OG000
- value
- 86
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 86
- units
- Participants
- description
- The FACT-G QOL instrument discriminates between individuals with metastatic and non-metastatic disease, as well as between patients at different stages of illness. The scale has good concurrent validity, high internal consistency (0.89), and good test-re-test reliability (0.82 to 0.88). The total score is reported, which is a combination of the subscales of physical, social/family, emotional, and functional well-being, with higher scores representing better QOL. Scale range 0-108
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. Standard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.
- id
- OG000
- title
- Standard Oral Hygiene
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes. Standard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
- id
- OG001
- title
- Standard Oral Hygiene + True Acupuncture
- description
- All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site. The Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points. Standard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
- id
- OG002
- title
- Standard Oral Hygiene + Sham Acupuncture
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Intent to treat analysis. Considered and utilized all data available at each timepoint.
- reporting Status
- POSTED
- time Frame
- Baseline, 4 , 8 , 12, and 26 weeks
- title
- Functional Assessment of Cancer Therapy (FACT-G) Total
- type
- SECONDARY
- unit Of Measure
- score on a scale 0-108
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Preserved source evidence · Not medical advice