Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.

Lifestyle intervention to reduce breast cancer risk

Jennifer Rusby

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.

PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk

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

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.

Proportion of women approached who go on to join the study

Attrition rate after randomisation within each group

Goal achievement in SNP group compared with goal achievement in non-SNP group.

Goal achievement compared between leaflet only group, website group and website + coaching group.

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.

Cancer Worry score compared with goal achievement. Cancer Worry score is between 8 and 32 with 32 being the highest level of anxiety.

Proportion of women still taking chemoprevention at close of study compared between the three arms.

Administration time required for each group; Average goal achievement compared to average cost of each intervention.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk	NCT04574063	Breast Cancer Lifestyle Risk ...	Lifestyle inter...	30 Years - 60 Years	Royal Marsden NHS Foundation Trust
PIONEER Study of Lifestyle Intervention to Reduced Breast Cancer Risk	NCT04574063	Breast Cancer Lifestyle Risk ...	Lifestyle inter...	30 Years - 60 Years	Royal Marsden NHS Foundation Trust

Spots Global Cancer Trial Database for lifestyle intervention to reduce breast cancer risk