TriangleNCT03674112 · OUTCOME
Percentage of Participants by Their Responses to Question 11 of the TASQ-IV and TASQ-SC, Assessing the Participants' Preferred Method for Receiving Cancer Treatment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Cycle 3 Day 1 and Cycle 6 Day 1 (each cycle is 21 days)
What was measured
The Therapy Administration Satisfaction Questionnaire (TASQ) is a 12-item, patient-reported questionnaire measuring the impact of the mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on 5 domains (questions \[Q\] 1 to 8 and Q12): Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. In addition, 3 questions in the TASQ-IV/-SC (Q 9-11) are not part of the domains. The TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received during the Cross-Over Period. Question 11 of the TASQ-IV/-SC asked the participant, "There are two ways to get cancer treatment: a) IV infusion given through a port or small tube; b) SC (subcutaneous) injection in your thigh. Which would you prefer?" There were three available options for the participant's response: IV, SC, or No Preference.
Analysis population: Modified Intent-to-Treat (mITT) Population
Groups in this outcome
All Participants: TASQ-IV Completers
This analysis set includes all participants from Arms A and B who completed the TASQ-IV questionnaire, which was administered at the last IV treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
All Participants: TASQ-SC Completers
This analysis set includes all participants from Arms A and B who completed the TASQ-SC questionnaire, which was administered at the last SC treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
| Group | Source count |
|---|---|
| All Participants: TASQ-IV Completers | 160 |
| All Participants: TASQ-SC Completers | 160 |
Reported measurements
Prefer IV Method
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 11.9 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 9.4 | Not reported | Not reported | Not reported | Not reported |
Prefer SC Method
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 70.6 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 82.5 | Not reported | Not reported | Not reported | Not reported |
No Preference
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 11.9 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 5.6 | Not reported | Not reported | Not reported | Not reported |
Patient Did Not Answer Question
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 5.6 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 2.5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 11.9
- group Id
- OG001
- value
- 9.4
- title
- Prefer IV Method
- categories
- measurements
- group Id
- OG000
- value
- 70.6
- group Id
- OG001
- value
- 82.5
- title
- Prefer SC Method
- categories
- measurements
- group Id
- OG000
- value
- 11.9
- group Id
- OG001
- value
- 5.6
- title
- No Preference
- categories
- measurements
- group Id
- OG000
- value
- 5.6
- group Id
- OG001
- value
- 2.5
- title
- Patient Did Not Answer Question
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 160
- units
- Participants
- description
- The Therapy Administration Satisfaction Questionnaire (TASQ) is a 12-item, patient-reported questionnaire measuring the impact of the mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on 5 domains (questions \[Q\] 1 to 8 and Q12): Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. In addition, 3 questions in the TASQ-IV/-SC (Q 9-11) are not part of the domains. The TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received during the Cross-Over Period. Question 11 of the TASQ-IV/-SC asked the participant, "There are two ways to get cancer treatment: a) IV infusion given through a port or small tube; b) SC (subcutaneous) injection in your thigh. Which would you prefer?" There were three available options for the participant's response: IV, SC, or No Preference.
- groups
- description
- This analysis set includes all participants from Arms A and B who completed the TASQ-IV questionnaire, which was administered at the last IV treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
- id
- OG000
- title
- All Participants: TASQ-IV Completers
- description
- This analysis set includes all participants from Arms A and B who completed the TASQ-SC questionnaire, which was administered at the last SC treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
- id
- OG001
- title
- All Participants: TASQ-SC Completers
- param Type
- NUMBER
- population Description
- Modified Intent-to-Treat (mITT) Population
- reporting Status
- POSTED
- time Frame
- Cycle 3 Day 1 and Cycle 6 Day 1 (each cycle is 21 days)
- title
- Percentage of Participants by Their Responses to Question 11 of the TASQ-IV and TASQ-SC, Assessing the Participants' Preferred Method for Receiving Cancer Treatment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice