An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer

Hoffmann-La Roche300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Breast Neoplasms

Interventions

No InterventionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * 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

Locations (14)

Nevill Hall Hospital

Abergavenny, United Kingdom

Colchester General Hospital

Colchester, Essex, United Kingdom

Royal Devon & Exeter Hospital; Oncology Centre

Exeter, United Kingdom

Outcomes

Primary Outcomes

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).

Time frame: Baseline

Secondary Outcomes

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".

Time frame: 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.

Data from ClinicalTrials.gov

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