A pilot study to investigate the effects on fitness and quality of life of an individualised exercise programme for breast cancer patients undergoing radiotherapy.

ISRCTN ISRCTN26140710
DOI https://doi.org/10.1186/ISRCTN26140710
Secondary identifying numbers N0265134364
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
01/10/2012
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

Dr A D Chetiyawardana
Scientific

Radiotherapy
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Phone +44 (0)121 472 1311

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives1. 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCancer: Breast
InterventionThe 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 typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/2003
Completion date01/11/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaFemale 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2003
Date of final enrolment01/11/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Radiotherapy
Birmingham
B15 2TH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

University Hospital Birmingham NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan