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ISRCTN
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ISRCTN43801571
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ClinicalTrials.gov identifier
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Public title
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Physical Activity during Cancer Treatment (PACT) study
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Scientific title
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A randomised clinical trial of physical exercise during cancer treatment: the PACT-study
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Acronym
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PACT
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Serial number at source
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NTR2138
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Study hypothesis
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We hypothesise that early physical exercise by reducing complaints of fatigue will lead to a reduction in sick leave and production losses. Altogether, we expect that physical exercise during cancer treatment will be cost-effective.
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Ethics approval
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Medical Ethics Committee of the University Medical Centre Utrecht approved on the 27th February 2008 (ref: 07/271/O)
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Study design
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Multicentre pragmatic randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Breast cancer/colon cancer
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Participants - inclusion criteria
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1. Recently diagnosed with breast or colon cancer (stage M0): histological diagnosis of cancer less than six (breast cancer) or ten (colon cancer) weeks ago
2. Treated with chemotherapy
3. Aged 25 - 75 years, either sex
4. Able to read and understand the Dutch language
5. Karnovsky Performance Status of 60 or higher
6. Able to walk 100 metres or more
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Participants - exclusion criteria
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1. Treated for cancer in the past five years (except basal skin cancer)
2. Contraindications for physical activity (Revised Physical Activity Readiness Questionnaire)
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Anticipated start date
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01/01/2010
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Anticipated end date
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31/12/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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300
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Interventions
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During an intake, patients will be included, baseline measurements will be taken and patients will be randomly allocated to the intervention or control group. Participants assigned to the intervention group will receive usual care in combination with an 18-week supervised group exercise program. They will be encouraged to attend the exercise program two times a week supervised by a physiotherapist.
Participants who will be assigned to the control group will receive usual care, i.e., no exercise intervention.
We will assess the short term as well as the long term effects. Short term effects will be measured 18 weeks after inclusion (at the end of the program) and long term effects will be measured 9 months after inclusion.
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Primary outcome measure(s)
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Measured at baseline, 18 weeks and 9 months:
1. Fatigue
2. Health service utilisation and sick leave
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Secondary outcome measure(s)
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Measured at baseline, 18 weeks and 9 months:
1. Health related quality of life
2. Anxiety and depression
3. Physical fitness
4. Body composition
5. Cognitive behavioural aspects
6. Physical activity level
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 171002202)
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Trial website
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Publications
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2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20534147
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Contact name
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Prof
Petra
Peeters
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Address
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Universitair Medisch Centrum Utrecht
Julius Center
PO Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508 GA
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Country
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Netherlands
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Email
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p.h.m.peeters@umcutrecht.nl
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Sponsor
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The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
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Address
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Laan van Nieuw Oost Indië 334
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City/town
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Den Haag
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Zip/Postcode
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2593 CE
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Country
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Netherlands
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Email
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rossum@zonmw.nl
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Sponsor website:
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http://www.zonmw.nl/
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Date applied
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17/12/2009
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Last edited
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17/08/2010
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Date ISRCTN assigned
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26/01/2010
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