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

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: Active, not recruiting
• Conditions: Breast Cancer; Lifestyle Risk Reduction
• Intervention / Treatment: Behavioral: Lifestyle intervention to reduce breast cancer risk

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Women will be asked this 12 months after entering the study

Secondary Outcome Measures

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	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	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	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	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	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	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	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	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	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

• Sponsor: Royal Marsden NHS Foundation Trust
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Jennifer Rusby, The Royal Marsden hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID 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