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ISRCTN
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ISRCTN26140710
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ClinicalTrials.gov identifier
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Public title
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A pilot study to investigate the effects on fitness and quality of life of an individualised exercise programme for breast cancer patients undergoing radiotherapy.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0265134364
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Study hypothesis
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1. Do fitness levels and perceptions of quality of life change during and following radiotherapy treatment for breast cancer?
2. Does an individualised exercise programme during radiotherapy treatment for cancer affect fitness levels?
3. Does perception of quality of life change during and following radiotherapy as a result of exercise intervention?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cancer: Breast
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Participants - inclusion criteria
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Female participants with breast cancer who are referred for a 3 week course of radiotherapy at the Queen Elizabeth Hospital, University Hospital Birmingham Trust will be invited to participate in the study when they are booked in. Inclusion criteria:
1. Participants will be recruited and randomised to control (n = 5) and intervention (n = 5) groups
2. Be able to complete the modified step test
3. Be able to understand instructions and complete an activity diary
4. Participants between the age of 50-70 years
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Participants - exclusion criteria
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1. Participants must be independent in self care and activities of daily living
2. Have no medical condition that prevents their participation in exercise (screening form and clearance for testing completed by Doctors at Clinic appointment)
3. Participants who will not be able to complete the requirements of assessments within the study
4. Participants having chemotherapy In addition to radiotherapy
5. Participants who have participated in the SEACRAB trial
6. Participants who are receiving radiotherapy for more than 3 weeks
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Anticipated start date
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01/11/2003
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Anticipated end date
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01/11/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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The following activities will be in addition to the normal treatment programme, but will be conducted as an extension of out-patient appointments at the hospital during radiotherapy treatment, with 2 additional visits following completion of treatment.
10 participants will be randomly allocated to a control (n = 5) or intervention (n = 5) group.
Participants will complete the following assessments:
1. A modified step test of three minutes duration to provide an index of fitness. (The modified test allows variation of step height with a minimum of inches, which makes the test achievable by a wider range of individuals.) This will be completed immediately before the commencement of radiotherapy treatment, and at weekly intervals until follow-up appointment at 6 weeks from end of treatment (Buckley 1999)
2. A quality of life (QoL) questionnaire (The European Organisation for Research and Treatment of Cancer - EORTC QLQ-C3O, version3). This is a cancer specific multidimensional tool (EORTC
2001). The questionnaire will be completed before commencement, at completion and
3 weeks following completion of the radiotherapy programme.
3. Participants will also keep an activity diary during treatment and for a period of 3 weeks following completion of the radiotherapy course. This will include a daily rating of fatigue (visual analogue scale), and identification of the level of activity with completion of a grid of activities completed and time for activity. This will be a simple sheet taking less than 5 minutes for participants to complete.
4. The intervention group will also complete an individualised exercise programme, throughout this data collection period, with review and progression evaluated on a weekly basis for individuals.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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University Hospital Birmingham NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
A D
Chetiyawardana
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Address
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Radiotherapy
Queen Elizabeth Hospital
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City/town
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Birmingham
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Zip/Postcode
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B15 2TH
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Country
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United Kingdom
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Tel
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+44 (0)121 472 1311
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Email
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)
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Address
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The Department of Health,
Richmond House,
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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10/06/2009
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Date ISRCTN assigned
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30/09/2004
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