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

Breast Neoplasms Clinical Trial

Official title:

UK HER2 Positive Breast Cancer Productivity & Utility Non-Interventional Study (PURPOSE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099200
• Other study ID #: ML30098
• Status: Completed
• Phase: N/A
• First received: March 31, 2017
• Last updated: March 31, 2017
• Start date: December 12, 2016
• Est. completion date: March 17, 2017

Study information

• Verified date: March 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 17, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• No Intervention

Locations

Country	Name	City	State
United Kingdom	Nevill Hall Hospital	Abergavenny
United Kingdom	Colchester General Hospital	Colchester, Essex
United Kingdom	Royal Devon & Exeter Hospital; Oncology Centre	Exeter
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	Ipswich Hospital; Clinical Oncology	Ipswich
United Kingdom	Barts and the London NHS Trust.	London
United Kingdom	St George's Hospital	London
United Kingdom	Christie Hospital; Breast Cancer Research Office	Manchester
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Mount Vernon Cancer Centre	Northwood
United Kingdom	Nottingham City Hospital; Oncology	Nottingham
United Kingdom	Royal Cornwall Hospital	Truro
United Kingdom	Pinderfields General Hospital	Wakefield
United Kingdom	Yeovil District Hospital; Macmillan Cancer Unit	Yeovil

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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".	Baseline
Secondary	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