TriangleNCT03674112 · OUTCOME
Percentage of Participants by Their Responses to Question 9 of the TASQ-IV and TASQ-SC, Assessing Whether Participants Receiving IV and SC Administration Have as Much Time as They Would Like to Talk to Their Nurse and/or Doctor About Their Illness
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 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. In addition, 3 questions (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 per arm during the Cross-Over Period. Question 9 asked the participant, "When you receive the IV infusion/SC injection treatment, are you able to talk to your nurse and/or doctor as much as you would like about your illness?" There were five available response options: a) Yes, I had more than enough time to talk to my nurse and/or doctor; b) Yes, but I would have liked more time to talk to my nurse and/or doctor; c) It does not matter to me if I have time to talk to my nurse and/or doctor during my treatment; d) No, I did not have enough time to talk to my nurse and/or doctor; and e) No, I did not talk to my nurse and/or doctor at all.
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
a) Yes, I had enough time to talk to my nurse and/or doctor
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 82.5 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 90.0 | Not reported | Not reported | Not reported | Not reported |
b) Yes, but I would have liked more time to talk to my nurse and/or doctor
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 9.4 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 5.0 | Not reported | Not reported | Not reported | Not reported |
c) It does not matter to me if I have time to talk to my nurse and/or doctor
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 5.0 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 3.1 | Not reported | Not reported | Not reported | Not reported |
d) No, I did not have enough time to talk to my nurse and/or doctor
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 0.6 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 0.6 | Not reported | Not reported | Not reported | Not reported |
e) No, I did not talk to my nurse and/or doctor at all
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 2.5 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 0.0 | Not reported | Not reported | Not reported | Not reported |
Patient did not answer question
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants: TASQ-IV Completers | 0.0 | Not reported | Not reported | Not reported | Not reported |
| All Participants: TASQ-SC Completers | 1.3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 82.5
- group Id
- OG001
- value
- 90.0
- title
- a) Yes, I had enough time to talk to my nurse and/or doctor
- categories
- measurements
- group Id
- OG000
- value
- 9.4
- group Id
- OG001
- value
- 5.0
- title
- b) Yes, but I would have liked more time to talk to my nurse and/or doctor
- categories
- measurements
- group Id
- OG000
- value
- 5.0
- group Id
- OG001
- value
- 3.1
- title
- c) It does not matter to me if I have time to talk to my nurse and/or doctor
- categories
- measurements
- group Id
- OG000
- value
- 0.6
- group Id
- OG001
- value
- 0.6
- title
- d) No, I did not have enough time to talk to my nurse and/or doctor
- categories
- measurements
- group Id
- OG000
- value
- 2.5
- group Id
- OG001
- value
- 0.0
- title
- e) No, I did not talk to my nurse and/or doctor at all
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 1.3
- title
- Patient did not answer question
- denoms
- counts
- group Id
- OG000
- value
- 160
- group Id
- OG001
- value
- 160
- units
- Participants
- description
- The 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. In addition, 3 questions (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 per arm during the Cross-Over Period. Question 9 asked the participant, "When you receive the IV infusion/SC injection treatment, are you able to talk to your nurse and/or doctor as much as you would like about your illness?" There were five available response options: a) Yes, I had more than enough time to talk to my nurse and/or doctor; b) Yes, but I would have liked more time to talk to my nurse and/or doctor; c) It does not matter to me if I have time to talk to my nurse and/or doctor during my treatment; d) No, I did not have enough time to talk to my nurse and/or doctor; and e) No, I did not talk to my nurse and/or doctor at all.
- 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 9 of the TASQ-IV and TASQ-SC, Assessing Whether Participants Receiving IV and SC Administration Have as Much Time as They Would Like to Talk to Their Nurse and/or Doctor About Their Illness
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice