Condition category
Cancer
Date applied
17/12/2009
Date assigned
26/01/2010
Last edited
16/07/2015
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

Prof Petra Peeters

ORCID ID

Contact details

Universitair Medisch Centrum Utrecht
Julius Center
PO Box 85500
Utrecht
3508 GA
Netherlands
-
p.h.m.peeters@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR2138

Study information

Scientific title

A randomised clinical trial of physical exercise during cancer treatment: the PACT study

Acronym

PACT

Study hypothesis

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.

Ethics approval

Medical Ethics Committee of the University Medical Centre Utrecht, 27/02/2008, ref: 07/271/O

Study design

Multicentre pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer/colon cancer

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Measured at baseline, 18 weeks and 9 months:
1. Fatigue
2. Health service utilisation and sick leave

Secondary outcome measures

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

Overall trial start date

01/01/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Treated for cancer in the past five years (except basal skin cancer)
2. Contraindications for physical activity (Revised Physical Activity Readiness Questionnaire)

Recruitment start date

01/01/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Universitair Medisch Centrum Utrecht
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Sponsor details

Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
Netherlands
-
rossum@zonmw.nl

Sponsor type

Research organisation

Website

http://www.zonmw.nl/

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

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

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20534147
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26050790

Publication citations

  1. Protocol

    Velthuis MJ, May AM, Koppejan-Rensenbrink RA, Gijsen BC, van Breda E, de Wit GA, Schröder CD, Monninkhof EM, Lindeman E, van der Wall E, Peeters PH, Physical Activity during Cancer Treatment (PACT) Study: design of a randomised clinical trial., BMC Cancer, 2010, 10, 272, doi: 10.1186/1471-2407-10-272.

  2. Results

    Travier N, Velthuis MJ, Steins Bisschop CN, van den Buijs B, Monninkhof EM, Backx F, Los M, Erdkamp F, Bloemendal HJ, Rodenhuis C, de Roos MA, Verhaar M, ten Bokkel Huinink D, van der Wall E, Peeters PH, May AM, Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial, BMC Med, 2015 , 13, 121, doi: 10.1186/s12916-015-0362-z.

Additional files

Editorial Notes