Reshaping breast care services - a role for dietitians?
| ISRCTN | ISRCTN87946139 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87946139 |
| Protocol serial number | 8.0 |
| Sponsor | Southampton University NHS Hospitals Trust (UK) |
| Funder | UK Department of Health, National Coordinating Centre for Research Capacity Development (Ref: PAS/RDA/01/05/2005) |
- 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
Scientific
Institute of Human Nutrition
Level E, Centre Block (MP893)
Southampton General Hospital
Tremona Rd
Southampton
SO16 6YD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mixed methods |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Reshaping breast care services - a role for dietitians? |
| Study objectives | 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(s) | Southampton & South West Hampshire Research Ethics Committee (B), 27/12/2006, ref: 06/Q1704/144 |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | A group 'healthy eating' program of 4 x 2 hour sessions over a six-month period vs usual care |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Number of women who enrol in the group healthy eating program |
| Key secondary outcome measure(s) |
1. Overall diet quality score |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 400 |
| Key inclusion criteria | All postmenopausal women diagnosed with breast cancer |
| Key exclusion criteria | All premenopausal women diagnosed with breast cancer |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/07/2017: No publications found, verifying study status with principal investigator.
