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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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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
Breast Neoplasms Other: No Intervention

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort 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



Primary Outcome Measures :
  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 [ 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).


Secondary Outcome Measures :
  1. 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".

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  • 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

Information from the National Library of Medicine

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


Locations
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United Kingdom
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
Freeman Hospital
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03099200    
Other Study ID Numbers: ML30098
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases