Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
01/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A D Chetiyawardana

ORCID ID

Contact details

Radiotherapy
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
+44 (0)121 472 1311

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 measures

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

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

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes