PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk (PIONEER)

January 17, 2023 updated by: Royal Marsden NHS Foundation Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • London Borough of Sutton, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Breast cancer risk leaflet only
No Intervention: Breast cancer risk leaflet PLUS SNPs
Experimental: Lifestyle website only
Behavioral: Lifestyle intervention to reduce breast cancer risk
Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
Experimental: Lifestyle website PLUS SNPs
Behavioral: Lifestyle intervention to reduce breast cancer risk
Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
Experimental: Lifestyle website PLUS group coaching
Behavioral: Lifestyle intervention to reduce breast cancer risk
Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
Experimental: Lifestyle website PLUS group coaching PLUS SNPs
Behavioral: Lifestyle intervention to reduce breast cancer risk
Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Women will be asked this 12 months after entering the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Proportion of women approached who go on to join the study
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
Attrition rate after randomisation within each group
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
Goal achievement in SNP group compared with goal achievement in non-SNP group.
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
Goal achievement compared between leaflet only group, website group and website + coaching group.
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
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 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
Cancer Worry score compared with goal achievement. Cancer Worry score is between 8 and 32 with 32 being the highest level of anxiety.
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
Participant retention rate.
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
Proportion of women still taking chemoprevention at close of study compared between the three arms.
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
Administration time required for each group; Average goal achievement compared to average cost of each intervention.
Measured when the final participant has completed 12 months in the study estimated 15 months from start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal Marsden NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Health Research, United Kingdom

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Rusby, The Royal Marsden Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCR 5113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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