An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03099200|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Other: No Intervention|
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||UK HER2 Positive Breast Cancer Productivity & Utility Non-Interventional Study (PURPOSE)|
|Actual Study Start Date :||December 12, 2016|
|Actual Primary Completion Date :||March 17, 2017|
|Actual Study Completion Date :||March 17, 2017|
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
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
Participants receiving treatment for metastatic breast cancer will be observed.
Other: No Intervention
- 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 [ Time Frame: 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).
- 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099200
|Nevill Hall Hospital|
|Abergavenny, United Kingdom, NP7 7EG|
|Colchester General Hospital|
|Colchester, Essex, United Kingdom, CO4 5JL|
|Royal Devon & Exeter Hospital; Oncology Centre|
|Exeter, United Kingdom, EX2 5DW|
|Royal Surrey County Hospital|
|Guildford, United Kingdom, GU2 7XX|
|Ipswich Hospital; Clinical Oncology|
|Ipswich, United Kingdom, IP4 5PD|
|Barts and the London NHS Trust.|
|London, United Kingdom, EC1A 7BE|
|St George's Hospital|
|London, United Kingdom, SW17 0QT|
|Christie Hospital; Breast Cancer Research Office|
|Manchester, United Kingdom, M20 4QL|
|Newcastle upon Tyne, United Kingdom, NE7 7DN|
|Mount Vernon Cancer Centre|
|Northwood, United Kingdom, HA6 2RN|
|Nottingham City Hospital; Oncology|
|Nottingham, United Kingdom, NG5 1PB|
|Royal Cornwall Hospital|
|Truro, United Kingdom, TR1 3LJ|
|Pinderfields General Hospital|
|Wakefield, United Kingdom, WF1 4DG|
|Yeovil District Hospital; Macmillan Cancer Unit|
|Yeovil, United Kingdom, BA21 4AT|
|Study Director:||Clinical Trials||Hoffmann-La Roche|