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The purpose of this study is to compare productivity (in terms of work or daily activity) and generic and disease-specific health-related quality of life of participants with HER2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted HER2 therapy), with participants who have completed adjuvant parenteral therapy, and participants with HER2 positive metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Participants with early breast cancer currently undergoing treatment (either chemotherapy and targeted HER2 therapy OR targeted HER2 therapy alone) will be observed. |
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| Cohort 2 | Participants with early breast cancer who have completed treatment and are in disease-free survival (i.e. no longer receiving loco-regional treatment, chemotherapy or targeted HER2 therapy; participants may still be receiving hormone therapy) will be observed. |
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| Cohort 3 | Participants receiving treatment for metastatic breast cancer will be observed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| A Comparison of Productivity, Assessed by Patient-Reported Work Productivity and Activity Impairment (WPAI) Questionnaire Score, of Participants in Cohort 1 vs Cohort 2 vs Cohort 3 | The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline along with absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity Impairment. The score range for the scales of the WPAI is between 0 (no effect) to 100% (max effect). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| A Comparison of Generic Health Related Quality of Life (HRQoL), Assessed by EuroQoL Health Related Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L) Score, of Participants in Cohort 1 vs Cohort 2 vs Cohort 3 | EQ-5D-5L is a standardized, participant-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the visual analogue scale (VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to choose one of 5 levels that best describes their health on that day: "no problem" (1), "slight" (2), "moderate" (3), "severe" (4), or "unable/extreme" (5). The VAS is the participant's rating of their health on a scale of 0 "worst health you can imagine" to 100 "best health you can imagine". |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with HER2 positive early breast cancer currently receiving adjuvant treatment (with chemotherapy and/or targeted HER2 therapy), or have completed treatment and in disease-free survival, or receiving treatment for metastatic breast cancer will be observed.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nevill Hall Hospital | Abergavenny | NP7 7EG | United Kingdom | |||
| Colchester General Hospital |
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| Baseline |
| A Comparison of Disease-Specific HRQoL, Assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) Score, of Participants in Cohort 1 vs Cohort 2 vs Cohort 3 | FACT-B was used as the breast cancer-specific quality-of-life measure. FACT-B consists of 5 subscale scores pertaining to 4 well-being dimensions (physical, social/family, emotional, functional) and additional breast cancer concerns. A total overall score is the sum of all subscales. Response options were 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. | Baseline |
| Colchester, Essex |
| CO4 5JL |
| United Kingdom |
| Royal Devon & Exeter Hospital; Oncology Centre | Exeter | EX2 5DW | United Kingdom |
| Royal Surrey County Hospital | Guildford | GU2 7XX | United Kingdom |
| Ipswich Hospital; Clinical Oncology | Ipswich | IP4 5PD | United Kingdom |
| Barts and the London NHS Trust. | London | EC1A 7BE | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Christie Hospital; Breast Cancer Research Office | Manchester | M20 4QL | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | HA6 2RN | United Kingdom |
| Nottingham City Hospital; Oncology | Nottingham | NG5 1PB | United Kingdom |
| Royal Cornwall Hospital | Truro | TR1 3LJ | United Kingdom |
| Pinderfields General Hospital | Wakefield | WF1 4DG | United Kingdom |
| Yeovil District Hospital; Macmillan Cancer Unit | Yeovil | BA21 4AT | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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