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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN26140710 |
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Date of registration:
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30/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/11/2003 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN26140710 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Not Specified)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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A D
Chetiyawardana |
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Address:
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Radiotherapy
Queen Elizabeth Hospital
B15 2TH
Birmingham
United Kingdom |
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Telephone:
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+44 (0)121 472 1311 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cancer: Breast
Cancer
Breast
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Intervention(s)
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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(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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N0265134364
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Source(s) of Monetary Support
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University Hospital Birmingham NHS Trust (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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