Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265134364
Study information
Scientific title
Acronym
Study hypothesis
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cancer: Breast
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2003
Overall trial end date
01/11/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant 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
Recruitment start date
01/11/2003
Recruitment end date
01/11/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Radiotherapy
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
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
Basic results (scientific)
Publication list