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

Primary Purpose

Breast Cancer, Lifestyle Risk Reduction

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Lifestyle intervention to reduce breast cancer risk
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • Aged between 30 and 60 years
  • Attending the symptomatic breast clinic at RMH Sutton
  • Benign or B3 diagnosis
  • Agree to receive their personalised breast cancer risk
  • Available to participate in a 1 year risk prevention programme

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.

Sites / Locations

  • The Royal Marsden Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Breast cancer risk leaflet only

Breast cancer risk leaflet PLUS SNPs

Lifestyle website only

Lifestyle website PLUS SNPs

Lifestyle website PLUS group coaching

Lifestyle website PLUS group coaching PLUS SNPs

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
To assess the acceptability of randomisation to different arms of intervention
Attrition rate after randomisation within each group
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.
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.
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.
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.
To identify whether commitment to a study of this design is sustainable and affected by study group
Participant retention rate.
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.
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.

Full Information

First Posted
September 7, 2020
Last Updated
January 17, 2023
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT04574063
Brief Title
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk
Acronym
PIONEER
Official Title
Pilot of Lifestyle InterventiON to reducE brEast Cancer RiSk (PIONEER)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lifestyle Risk Reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast cancer risk leaflet only
Arm Type
No Intervention
Arm Title
Breast cancer risk leaflet PLUS SNPs
Arm Type
No Intervention
Arm Title
Lifestyle website only
Arm Type
Experimental
Arm Title
Lifestyle website PLUS SNPs
Arm Type
Experimental
Arm Title
Lifestyle website PLUS group coaching
Arm Type
Experimental
Arm Title
Lifestyle website PLUS group coaching PLUS SNPs
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle intervention to reduce breast cancer risk
Intervention Description
Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
Primary Outcome Measure Information:
Title
Goal achievement
Description
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.
Time Frame
Women will be asked this 12 months after entering the study
Secondary Outcome Measure Information:
Title
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
Description
Proportion of women approached who go on to join the study
Time Frame
Measured when recruitment is complete, estimated at 3 months from start date
Title
To assess the acceptability of randomisation to different arms of intervention
Description
Attrition rate after randomisation within each group
Time Frame
Measured when the final participant has completed 12 months in the study, estimated 15 months from start date
Title
To assess the impact of SNP testing on changes in behavioural risk factors
Description
Goal achievement in SNP group compared with goal achievement in non-SNP group.
Time Frame
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Title
To assess the impact of the different interventions on changes in behavioural risk factors
Description
Goal achievement compared between leaflet only group, website group and website + coaching group.
Time Frame
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Title
To assess the impact of knowledge of breast cancer risk on cancer anxiety scores
Description
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.
Time Frame
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Title
To identify whether there is an association between initial Cancer Worry Scale (Revised) score and change in behavioural risk factors
Description
Cancer Worry score compared with goal achievement. Cancer Worry score is between 8 and 32 with 32 being the highest level of anxiety.
Time Frame
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Title
To identify whether commitment to a study of this design is sustainable and affected by study group
Description
Participant retention rate.
Time Frame
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Title
To assess the impact of the different interventions on uptake and adherence to chemoprevention at 1 year
Description
Proportion of women still taking chemoprevention at close of study compared between the three arms.
Time Frame
Measured when the final participant has completed 12 months in the study estimated 15 months from start date
Title
To consider the scalability of each element of the pilot study
Description
Administration time required for each group; Average goal achievement compared to average cost of each intervention.
Time Frame
Measured when the final participant has completed 12 months in the study estimated 15 months from start date

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Rusby
Organizational Affiliation
The Royal Marsden Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Marsden Hospital NHS Foundation Trust
City
London Borough of Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

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