Reshaping breast care services - a role for dietitians?

ISRCTN ISRCTN87946139
DOI https://doi.org/10.1186/ISRCTN87946139
Secondary identifying numbers 8.0
Submission date
06/03/2007
Registration date
24/04/2007
Last edited
10/07/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Jillian Milne
Scientific

Institute of Human Nutrition
Level E, Centre Block (MP893)
Southampton General Hospital
Tremona Rd
Southampton
SO16 6YD
United Kingdom

Study information

Study designMixed methods
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleReshaping breast care services - a role for dietitians?
Study objectives1. 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(s)Southampton & South West Hampshire Research Ethics Committee (B), 27/12/2006, ref: 06/Q1704/144
Health condition(s) or problem(s) studiedBreast cancer
InterventionA group 'healthy eating' program of 4 x 2 hour sessions over a six-month period vs usual care
Intervention typeBehavioural
Primary outcome measureNumber of women who enrol in the group healthy eating program
Secondary outcome measures1. Overall diet quality score
2. Weight
Overall study start date01/04/2007
Completion date31/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants400
Key inclusion criteriaAll postmenopausal women diagnosed with breast cancer
Key exclusion criteriaAll premenopausal women diagnosed with breast cancer
Date of first enrolment01/04/2007
Date of final enrolment31/05/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University NHS Hospitals Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Government

UK Department of Health, National Coordinating Centre for Research Capacity Development (Ref: PAS/RDA/01/05/2005)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

10/07/2017: No publications found, verifying study status with principal investigator.