Investigating the protocols for radiotherapy to the breast: an evaluation of treatment morbidity, accuracy and efficiency
ISRCTN | ISRCTN34017998 |
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DOI | https://doi.org/10.1186/ISRCTN34017998 |
Secondary identifying numbers | N0461053544 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 19/02/2018
- 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 Heidi Probst
Scientific
Scientific
Cookridge Hospital
Yorkshire Centre for Clinical Oncology
Hospital Lane
Leeds
LS16 6QB
United Kingdom
Phone | +44 (0)113 392 4104 |
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HEIDIP@ulth.northy.nhs.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
Scientific title | Investigating the protocols for radiotherapy to the breast: an evaluation of treatment morbidity, accuracy and efficiency |
Study objectives | The principal research questions: 1. Does a reduction in the central lung depth of a tangential breast field correspond to a clinically measurable difference in patient reported respiratory symptoms? 2. What are the treatment and patient related factors that influence patient reported respiratory symptoms? 3. Does the method of skin marking affect the accuracy and reproducibility of the radiotherapy treatment? 4. Does the method of skin marking affect patient reports of perceived body image. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Breast cancer |
Intervention | Patients that consent to participate are randomised to one of two lung depth groups and one of two skin marking categories. |
Intervention type | Other |
Primary outcome measure | 1. Quality of life, assessed using EORTC QLQ C- 30 pre treatment and ten week post treatment 2. Treatment accuracy assessed by measuring radiation field placement in relation to the patient's' anatomy on three portal images taken during the treatment course. Measurements are compared with dimensions calculated during the patient's' initial treatment planning session. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 10/01/1999 |
Completion date | 12/01/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | Not provided at time of registration |
Key inclusion criteria | All patients diagnosed with stage I and II breast cancer referred for adjuvant radiotherapy under three specialist breast oncologists (at Cookridge Hospital, Leeds) |
Key exclusion criteria | Does not meet inclusion criteria |
Date of first enrolment | 10/01/1999 |
Date of final enrolment | 12/01/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cookridge Hospital
Leeds
LS16 6QB
United Kingdom
LS16 6QB
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive Northern and Yorkshire (UK) (ref: RRCC715F Probst)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
19/02/2018: No publications found, verifying study status with principal investigator.
26/11/2015: No publications found on PubMed.