Physical activity during cancer treatment (PACT) study
| ISRCTN | ISRCTN43801571 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43801571 |
| Secondary identifying numbers | NTR2138 |
- Submission date
- 17/12/2009
- Registration date
- 26/01/2010
- Last edited
- 17/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Petra Peeters
Scientific
Scientific
Universitair Medisch Centrum Utrecht
Julius Center
PO Box 85500
Utrecht
3508 GA
Netherlands
| p.h.m.peeters@umcutrecht.nl |
Study information
| Study design | Multicentre pragmatic randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised clinical trial of physical exercise during cancer treatment: the PACT study |
| Study acronym | PACT |
| Study objectives | 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(s) | Medical Ethics Committee of the University Medical Centre Utrecht, 27/02/2008, ref: 07/271/O |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2010 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 92 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Universitair Medisch Centrum Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
Netherlands
| rossum@zonmw.nl | |
| Website | http://www.zonmw.nl/ |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/06/2010 | Yes | No | |
| Results article | results | 08/06/2015 | Yes | No | |
| Results article | results | 01/05/2016 | Yes | No | |
| Results article | results | 08/05/2019 | 10/01/2020 | Yes | No |
| Results article | follow up results | 16/04/2020 | 17/07/2020 | Yes | No |
Editorial Notes
17/07/2020: Publication reference added.
10/01/2020: Publication reference and total final enrolment number added.
20/01/2017: Publication reference added.
