Condition category
Cancer
Date applied
06/03/2007
Date assigned
24/04/2007
Last edited
09/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jillian Milne

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Southampton University NHS Hospitals Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Government

Website

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

Publication citations

Additional files

Editorial Notes