Condition category
Cancer
Date applied
30/06/2005
Date assigned
23/08/2005
Last edited
25/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Amanda Daley

ORCID ID

Contact details

Primary Care and General Practice
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3762
a.daley@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

c8304/a3042

Study information

Scientific title

Acronym

Study hypothesis

Exercise therapy will improve quality of life in women who have had breast cancer

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

Treatment

Patient information sheet

Condition

Breast cancer

Intervention

Exercise therapy versus continuing life as normal

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quality of life

Secondary outcome measures

Physical activity, depression, satisfaction with life, body fat, aerobic fitness

Overall trial start date

01/01/2003

Overall trial end date

31/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Sedentary women who are between 1-3 years post treatment

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

Participant exclusion criteria

Aged 66 years or more

Recruitment start date

01/01/2003

Recruitment end date

31/01/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Care and General Practice
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

Sheffield Hallam University (UK)

Sponsor details

Centre for Sport and Exercise Science
Sheffield Hallam University
Sheffield
S10 2BP
United Kingdom
+44 (0)1142252544
a.daley@shu.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2004 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15198998
2. 2007 participant recruitment in http://www.ncbi.nlm.nih.gov/pubmed/17433791
3. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17470863

Publication citations

  1. Protocol

    Daley AJ, Mutrie N, Crank H, Coleman R, Saxton J, Exercise therapy in women who have had breast cancer: design of the Sheffield women's exercise and well-being project., Health Educ Res, 2004, 19, 6, 686-697, doi: 10.1093/her/cyg094.

  2. Participant recruitment

    Daley AJ, Crank H, Mutrie N, Saxton JM, Coleman R, Patient recruitment into a randomised controlled trial of supervised exercise therapy in sedentary women treated for breast cancer., Contemp Clin Trials, 2007, 28, 5, 603-613, doi: 10.1016/j.cct.2007.02.009.

  3. Results

    Daley AJ, Crank H, Saxton JM, Mutrie N, Coleman R, Roalfe A, Randomized trial of exercise therapy in women treated for breast cancer., J. Clin. Oncol., 2007, 25, 13, 1713-1721, doi: 10.1200/JCO.2006.09.5083.

Additional files

Editorial Notes