Breast CancerPIONEERNCT04574063
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk
A study testing Lifestyle intervention to reduce breast cancer risk in people with Breast Cancer and Lifestyle Risk Reduction, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women only
- Conditions the study is for
- Breast Cancer, Lifestyle Risk Reduction
- What is being tested?
- Lifestyle intervention to reduce breast cancer risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Sep 2020to Dec 2023
- Phase
- Interventional
- 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 30 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Aged between 30 and 60 years
- Attending the symptomatic breast clinic at RMH Sutton or Chelsea OR the family history clinics at RMH Sutton or Chelsea, or has heard about the study through other means such as (but not limited to), friends who have been diagnosed with cancer, friends who are already taking part in the PIONEER study, social media, mainstream media, fliers through the doors of houses in the area of RMH.
- Benign or B3 diagnosis if participant has attended clinic
- Agree to receive their personalised breast cancer risk
- Available to participate in a 1 year risk prevention programme
- Able to attend the Royal Marsden for a blood test if randomised to this group
Who cannot join
- Malignant Diagnosis
- Does not want to find out personalised breast cancer risk
- Not available to participate for the full year
- NOTE: after risk assessment, women who have a breast cancer risk lower than that of population level will be excluded from participating in the behavioural change elements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden Hospital NHS Foundation Trust
Sutton, SM2 5PT
About this study
Official title: Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. They will be told their estimated risk of developing breast cancer and will be randomised to one of three interventions:
- Breast cancer risk leaflet only
- lifestyle website
- lifestyle website plus group coaching.
Fifty per cent of women will also be randomised to have Single Nucleotide Polymorphisms (SNPs) performed, and these will be incorporated into their risk score.
The primary end point will be whether or not women achieve their lifestyle goal.
- Conditions
- Breast Cancer, Lifestyle Risk Reduction
- Being tested
- Lifestyle intervention to reduce breast cancer risk
- Medical subject headings
- Breast Neoplasms, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle intervention to reduce breast cancer riskBehavioural
Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer risk leaflet only | No intervention | Not described |
| Breast cancer risk leaflet PLUS SNPs | No intervention | Not described |
| Lifestyle website only | Experimental | Not described Receives: Behavioral: Lifestyle intervention to reduce breast cancer risk |
| Lifestyle website PLUS SNPs | Experimental | Not described Receives: Behavioral: Lifestyle intervention to reduce breast cancer risk |
| Lifestyle website PLUS group coaching | Experimental | Not described Receives: Behavioral: Lifestyle intervention to reduce breast cancer risk |
| Lifestyle website PLUS group coaching PLUS SNPs | Experimental | Not described Receives: Behavioral: Lifestyle intervention to reduce breast cancer risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal achievement
Whether women have achieved their lifestyle goals. Proportion answering "yes" to a binary question: Did you achieve the goal you set? Compared between the three arms.
Measured: Women will be asked this 12 months after entering the study
Secondary outcomes (9)
To assess the acceptability of women to find out their personalised breast cancer risk and to commit to making a change in a modifiable risk factor
Proportion of women approached who go on to join the study
Measured: Measured when recruitment is complete, estimated at 3 months from start date
To assess the acceptability of randomisation to different arms of intervention
Attrition rate after randomisation within each group
Measured: Measured when the final participant has completed 12 months in the study, estimated 15 months from start date
To assess the impact of SNP testing on changes in behavioural risk factors
Goal achievement in SNP group compared with goal achievement in non-SNP group.
Measured: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of the different interventions on changes in behavioural risk factors
Goal achievement compared between leaflet only group, website group and website + coaching group.
Measured: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of knowledge of breast cancer risk on cancer anxiety scores
Change in Cancer Worry Scale (Revised) score from 0 to 3 months. Cancer Worry score is measured between 8 and 32 with 32 being the highest level of anxiety.
Measured: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To identify whether there is an association between initial Cancer Worry Scale (Revised) score and change in behavioural risk factors
Cancer Worry score compared with goal achievement. Cancer Worry score is between 8 and 32 with 32 being the highest level of anxiety.
Measured: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To identify whether commitment to a study of this design is sustainable and affected by study group
Participant retention rate.
Measured: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of the different interventions on uptake and adherence to chemoprevention at 1 year
Proportion of women still taking chemoprevention at close of study compared between the three arms.
Measured: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To consider the scalability of each element of the pilot study
Administration time required for each group; Average goal achievement compared to average cost of each intervention.
Measured: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Sep 2020
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Jennifer Rusby, Principal investigator, The Royal Marsden Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574063
- Sponsor's protocol ID
- CCR 5113
- Acronym
- PIONEER
- Status last verified
- Jan 2023
- First submitted
- 7 Sep 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Law R, Krupa K, Rusby J. Preventative therapy for breast cancer: a clinical experience. Breast Cancer Res Treat. 2023 Sep;201(2):205-213. doi: 10.1007/s10549-023-06985-1. Epub 2023 Jun 19.
PubMed 37336835
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
- ClinicalTrials.gov ID
- NCT04574063
- Acronym / sponsor ID
- PIONEER / CCR 5113
- Conditions
- Breast Cancer, Lifestyle Risk Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 5 Oct 2020 (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.
A randomised controlled trial in which women discharged from the symptomatic breast clinic, who are above population risk (according to Tyrer Cuzick) will be asked to create lifestyle related goals. They will be told their estimated risk of developing breast cancer and will be randomised to one of three interventions:
- Breast cancer risk leaflet only
- lifestyle website
- lifestyle website plus group coaching.
Fifty per cent of women will also be randomised to have Single Nucleotide Polymorphisms (SNPs) performed, and these will be incorporated into their risk score.
The primary end point will be whether or not women achieve their lifestyle goal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Breast cancer risk leaflet only | No intervention | – |
| Breast cancer risk leaflet PLUS SNPs | No intervention | – |
| Lifestyle website only | Experimental | Behavioral: Lifestyle intervention to reduce breast cancer risk |
| Lifestyle website PLUS SNPs | Experimental | Behavioral: Lifestyle intervention to reduce breast cancer risk |
| Lifestyle website PLUS group coaching | Experimental | Behavioral: Lifestyle intervention to reduce breast cancer risk |
| Lifestyle website PLUS group coaching PLUS SNPs | Experimental | Behavioral: Lifestyle intervention to reduce breast cancer risk |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female
- Aged between 30 and 60 years
- Attending the symptomatic breast clinic at RMH Sutton or Chelsea OR the family history clinics at RMH Sutton or Chelsea, or has heard about the study through other means such as (but not limited to), friends who have been diagnosed with cancer, friends who are already taking part in the PIONEER study, social media, mainstream media, fliers through the doors of houses in the area of RMH.
- Benign or B3 diagnosis if participant has attended clinic
- Agree to receive their personalised breast cancer risk
Key exclusion criteria (4 listed)
- Malignant Diagnosis
- Does not want to find out personalised breast cancer risk
- Not available to participate for the full year
- NOTE: after risk assessment, women who have a breast cancer risk lower than that of population level will be excluded from participating in the behavioural change elements.
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 |
|---|---|---|
| Lifestyle intervention to reduce breast cancer riskWomen will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process. | Behavioural | Lifestyle website PLUS SNPs, Lifestyle website PLUS group coaching, Lifestyle website PLUS group coaching PLUS SNPs, Lifestyle website only |
Primary outcome
Goal achievement
Time frame: Women will be asked this 12 months after entering the study
Whether women have achieved their lifestyle goals. Proportion answering "yes" to a binary question: Did you achieve the goal you set? Compared between the three arms.
9 secondary outcomes
To assess the acceptability of women to find out their personalised breast cancer risk and to commit to making a change in a modifiable risk factor
Time frame: Measured when recruitment is complete, estimated at 3 months from start date
To assess the acceptability of randomisation to different arms of intervention
Time frame: Measured when the final participant has completed 12 months in the study, estimated 15 months from start date
To assess the impact of SNP testing on changes in behavioural risk factors
Time frame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of the different interventions on changes in behavioural risk factors
Time frame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of knowledge of breast cancer risk on cancer anxiety scores
Time frame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To identify whether there is an association between initial Cancer Worry Scale (Revised) score and change in behavioural risk factors
Time frame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To identify whether commitment to a study of this design is sustainable and affected by study group
Time frame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To assess the impact of the different interventions on uptake and adherence to chemoprevention at 1 year
Time frame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
To consider the scalability of each element of the pilot study
Time frame: Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 37336835Law R, Krupa K, Rusby J. Preventative therapy for breast cancer: a clinical experience. Breast Cancer Res Treat. 2023 Sep;201(2):205-213. doi: 10.1007/s10549-023-06985-1. Epub 2023 Jun 19.
- Individual participant dataSharing planned: No
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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.
Jennifer Rusby principal investigator
The Royal Marsden Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention to reduce breast cancer risk in people with Breast Cancer and Lifestyle Risk Reduction, run by Royal Marsden NHS Foundation Trust at 1 site 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Goal achievement (time frame: Women will be asked this 12 months after entering the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574063, which also lists 1 linked publication.
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 18 Jan 2023.