Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
8.0
Study information
Scientific title
Reshaping breast care services - a role for dietitians?
Acronym
Study hypothesis
1. Of all postmenopausal women diagnosed with breast cancer and offered the intervention 50% will enrol on a group healthy eating program.
2. Difference in change of overall diet quality scores will be 10 points higher for women in the 'healthy eating' group compared to women in usual care.
Ethics approval
Southampton & South West Hampshire Research Ethics Committee (B), 27/12/2006, ref: 06/Q1704/144
Study design
Mixed methods
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
A group 'healthy eating' program of 4 x 2 hour sessions over a six-month period vs usual care
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Number of women who enrol in the group healthy eating program
Secondary outcome measures
1. Difference in change of overall diet quality scores between women enrolled in the 'healthy eating' group compared to women in usual care
2. Difference in change in weight between women enrolled in the 'healthy eating' group compared to women in usual care
Overall trial start date
01/04/2007
Overall trial end date
31/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
All postmenopausal women diagnosed with breast cancer
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Participant exclusion criteria
All premenopausal women diagnosed with breast cancer
Recruitment start date
01/04/2007
Recruitment end date
31/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Human Nutrition
Southampton
SO16 6YD
United Kingdom
Funders
Funder type
Government
Funder name
UK Department of Health, National Coordinating Centre for Research Capacity Development (Ref: PAS/RDA/01/05/2005)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary