Breast NeoplasmsNCT03099200
An Observational Study Evaluating the Productivity and Health-Related Quality of Life of People With HER2 Positive Breast Cancer
An observational study of Breast Neoplasms, run by Hoffmann-La Roche at 14 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasms
- How many people
- 300 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 12 Dec 2016to 17 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Unwilling or unable to consent.
- Unable to complete written quality of life questionnaires
- Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United Kingdom14 sites
Nevill Hall Hospital
Abergavenny, NP7 7EG
Colchester General Hospital
Colchester, Essex, CO4 5JL
Royal Devon & Exeter Hospital; Oncology Centre
Exeter, EX2 5DW
Royal Surrey County Hospital
Guildford, GU2 7XX
Ipswich Hospital; Clinical Oncology
Ipswich, IP4 5PD
Barts and the London NHS Trust.
London, EC1A 7BE
St George's Hospital
London, SW17 0QT
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Mount Vernon Cancer Centre
Northwood, HA6 2RN
Nottingham City Hospital; Oncology
Nottingham, NG5 1PB
Royal Cornwall Hospital
Truro, TR1 3LJ
Pinderfields General Hospital
Wakefield, WF1 4DG
Yeovil District Hospital; Macmillan Cancer Unit
Yeovil, BA21 4AT
About this study
Official title: UK HER2 Positive Breast Cancer Productivity & Utility Non-Interventional Study (PURPOSE)
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
- Being tested
- No Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Participants with early breast cancer currently undergoing treatment (either chemotherapy and targeted HER2 therapy OR targeted HER2 therapy alone) will be observed. Receives: 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. Receives: Other: No Intervention | |
| Cohort 3 | Participants receiving treatment for metastatic breast cancer will be observed. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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".
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start12 Dec 2016
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099200
- Sponsor's protocol ID
- ML30098
- Status last verified
- Mar 2017
- First submitted
- 31 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK HER2 Positive Breast Cancer Productivity & Utility Non-Interventional Study (PURPOSE)
- ClinicalTrials.gov ID
- NCT03099200
- Acronym / sponsor ID
- ML30098
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: No InterventionParticipants with early breast cancer currently undergoing treatment (either chemotherapy and targeted HER2 therapy OR targeted HER2 therapy alone) will be observed. |
| Cohort 2 | – | Other: No InterventionParticipants 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. |
| Cohort 3 | – | Other: No InterventionParticipants receiving treatment for metastatic breast cancer will be observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Unwilling or unable to consent.
- Unable to complete written quality of life questionnaires
- Partcipants with Eastern Cooperative Oncology Group (ECOG) Performance Status ≥3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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).
2 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
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
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Hoffmann-La Roche at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.