An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Participants with early breast cancer currently undergoing treatment (either chemotherapy and targeted HER2 therapy OR targeted HER2 therapy alone) will be observed. |
Other: No Intervention
|
| 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. |
Other: No Intervention
|
| Cohort 3 Participants receiving treatment for metastatic breast cancer will be observed. |
Other: No Intervention
|
Outcome Measures
Primary Outcome Measures
- 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 [Baseline]
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).
Secondary Outcome Measures
- 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 [Baseline]
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".
- 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 [Baseline]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). [HER2-positive is defined as ImmunoHistoChemistry (IHC3+) and/or in situ hybridization (ISH) ≥2.0]
-
Able to provide written, informed consent.
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Early Stage Breast Cancer (eBC) patients must have received at least 1 cycle of adjuvant anti-cancer therapy following surgery; metastatic breast cancer (mBC) patients must have received at least 1 cycle of treatment for their metastatic disease.
Exclusion Criteria:
-
Unwilling or unable to consent.
-
Unable to complete written quality of life questionnaires
-
Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nevill Hall Hospital | Abergavenny | United Kingdom | NP7 7EG | |
| 2 | Colchester General Hospital | Colchester, Essex | United Kingdom | CO4 5JL | |
| 3 | Royal Devon & Exeter Hospital; Oncology Centre | Exeter | United Kingdom | EX2 5DW | |
| 4 | Royal Surrey County Hospital | Guildford | United Kingdom | GU2 7XX | |
| 5 | Ipswich Hospital; Clinical Oncology | Ipswich | United Kingdom | IP4 5PD | |
| 6 | Barts and the London NHS Trust. | London | United Kingdom | EC1A 7BE | |
| 7 | St George's Hospital | London | United Kingdom | SW17 0QT | |
| 8 | Christie Hospital; Breast Cancer Research Office | Manchester | United Kingdom | M20 4QL | |
| 9 | Freeman Hospital | Newcastle upon Tyne | United Kingdom | NE7 7DN | |
| 10 | Mount Vernon Cancer Centre | Northwood | United Kingdom | HA6 2RN | |
| 11 | Nottingham City Hospital; Oncology | Nottingham | United Kingdom | NG5 1PB | |
| 12 | Royal Cornwall Hospital | Truro | United Kingdom | TR1 3LJ | |
| 13 | Pinderfields General Hospital | Wakefield | United Kingdom | WF1 4DG | |
| 14 | Yeovil District Hospital; Macmillan Cancer Unit | Yeovil | United Kingdom | BA21 4AT |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ML30098