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

NCT03099200 | Completed

• 1 other identifier: ML30098
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 14

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (3)

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

Interventions

No Intervention OTHER

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Unwilling or unable to consent.
• Unable to complete written quality of life questionnaires
• Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (14)

Nevill Hall Hospital

Abergavenny, NP7 7EG, United Kingdom

Location

Colchester General Hospital

Colchester, Essex, CO4 5JL, United Kingdom

Location

Royal Devon & Exeter Hospital; Oncology Centre

Exeter, EX2 5DW, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

Ipswich Hospital; Clinical Oncology

Ipswich, IP4 5PD, United Kingdom

Location

Barts and the London NHS Trust.

London, EC1A 7BE, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Christie Hospital; Breast Cancer Research Office

Manchester, M20 4QL, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, HA6 2RN, United Kingdom

Location

Nottingham City Hospital; Oncology

Nottingham, NG5 1PB, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LJ, United Kingdom

Location

Pinderfields General Hospital

Wakefield, WF1 4DG, United Kingdom

Location

Yeovil District Hospital; Macmillan Cancer Unit

Yeovil, BA21 4AT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 4, 2017
• Study Start: December 12, 2016
• Primary Completion: March 17, 2017
• Study Completion: March 17, 2017
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

GB (14)