PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

Breast Cancer Clinical Trial

— PIONEER  

Official title:

Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04574063
• Other study ID #: CCR 5113
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: December 2023

Study information

• Verified date: January 2023
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lifestyle Risk Reduction

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden Hospital NHS Foundation Trust	London Borough of Sutton

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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