Breast CancerPhysSurg-BNCT02560662
PhysSurg-B : Physical Activity in Relation to Surgical Operations - Breast Cancer
A study testing Physical activity in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 27 Jan 2016to 11 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All female patients at the participating hospital scheduled for breast cancer surgery will be asked to participate.
Who cannot join
- Inability to understand given information.
- Inability to perform the intervention, as assessed by the person performing inclusion.
- Withdrawal of informed consent.
- Male sex.
- Stage IV breast cancer at diagnosis.
- Neoadjuvant breast cancer treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PhysSurg-B : Physical Activity in Relation to Surgical Operations, a Prospective Open-label Randomized Controlled Multicenter Study of the Effect of Physical Activity on Recovery After Breast Cancer Surgery
The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery.
Read the detailed description
This study is designed as a randomised, controlled, non-blinded multicenter trial with two parallell study groups, intervention and control. The primary endpoint of recovery is measured within 12 months after surgery.
After randomisation, participants in the intervention group will be scheduled for an individual consultation with the physiotherapist, where the are advised to increase their Daily physical activiy level with an additional 30 minutes. The added physical activity is registered in an exercise diary daily.
All included participants will be asked to complete questionnaires at inclusion (I), 4 weeks (+/- 1 w) postoperatively (II) and 12 months (+/-1 month) postoperatively (III).
Data regarding patient characteristics, surgical details, postoperative events, complications according to Clavien - Dindo and additional treatment will be collected using eCRF: (I) 30 Days postoperatively, (II) 90 days postoperatively and (III) 12 months postoperatively. Data will also be retrieved from the Swedish National Breast Cancer Register, the Swedish Social Insurance Agency and the Swedish National Death Register.
Patrticipants who wish to be excluded from the study will be asked if already collected data may be analysed in the study.
The code for the study cohort will include personal identity as well as a study specific code. This is placed on a server, with limited access, at Sahlgrenska University Hospital. The database is placed on a server within the University of Gothenburg system accessible with username and code. The database includes only the study specific code for each participant. Data from questionnaires will be entered manually. Length of hospital stay will be acquired from the hospital registries and then entered manually into the database. Data from CRF (I-III) will be entered in the same database, as well as data retrieved from the Swedish National Breast Cancer Register, the National Death Register and Swedish Social Insurance Agency.
In all a high security standard with automatic back up of server data is present as well as firewalls against external violation. A data manager, employed by the SSORG unit will be responsible for the database.
The investigators plan to perform an interim analysis for the first 100 patients included, in order to make a more exact estimate of the power needed. An external monitoring committee will be appointed for the interim analysis, and the question to the committee will be limited to a recalculation of cohort size.The participants will be analysed according to randomisation (intention to treat-type of analysis).
- Conditions
- Breast Cancer
- Being tested
- Physical activity
- Keywords
- Breast cancer, physical exercise, recovery
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
Preoperative intervention - takes place from randomization until surgery (4 weeks +/-2 w):
- 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort.
Postoperative intervention - takes place from discharge from the hospital until 4 weeks postoperatively:
- 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort.
Participants randomized to intervention will receive a visit to a physiotherapist for personally adjusted information regarding the intervention, later followed up with a telephone call.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Individual consultation with a physiotherapist in order to increase the participants existing level of physical activity by adding 30minutes of physical activity daily, preoperatively and 4 weeks postoperatively. Receives: Behavioral: Physical activity |
| Control | No intervention | Participants randomized to the control group will not be advised to change their current level of physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported physical and psychological recovery
Measured using validated questions within a questionnaire
Measured: Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively
Sick leave
Data from the Swedish Social Insurance Agency (Försäkringskassan) on total number of days and the reasons (diagnosis) for any sick-leave episodes
Measured: 12 months postoperatively
Secondary outcomes (5)
Length of hospital stay
For each participant the number of days of hospital stay for the index surgery will be collected
Measured: 30 days postoperatively
Adverse events
Classified according to Clavien-Dindo
Measured: 90 days postoperatively
Re-operations and re-admittances
The number of participants with re-admittances to hospital and/or re-operations after the index surgery will be retrieved from hospital registration systems and analyzed
Measured: 12 months postoperatively
Mortality
Data retrieved from National Death Register, overall and cancer-specific mortality
Measured: 3 and 5 years postoperatively
Health economy
Analysis using modelling, focusing on the societal perspective and measuring the effects of regular physical exercise for resource consumption, measured in Swedish currency SEK.
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start27 Jan 2016
- Primary completion10 Mar 2019
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roger Olofsson Bagge, Sahlgrenska University Hospital
- Investigators
- Roger Olofsson Bagge, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560662
- Sponsor's protocol ID
- PhysSurg-B
- Acronym
- PhysSurg-B
- Status last verified
- Jan 2024
- First submitted
- 23 Sep 2015
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heiman J, Onerup A, Bock D, Haglind E, Olofsson Bagge R. The effect of nonsupervised physical activity before and after breast cancer surgery on quality of life: Results from a randomized controlled trial (PhysSURG-B). Scand J Surg. 2022 Dec;111(4):75-82. doi: 10.1177/14574969221123389. Epub 2022 Sep 15.
PubMed 36113110Heiman J, Onerup A, Wessman C, Haglind E, Olofsson Bagge R. Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial. Br J Surg. 2021 Jan 27;108(1):32-39. doi: 10.1093/bjs/znaa007.
PubMed 33640941
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhysSurg-B : Physical Activity in Relation to Surgical Operations, a Prospective Open-label Randomized Controlled Multicenter Study of the Effect of Physical Activity on Recovery After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02560662
- Acronym / sponsor ID
- PhysSurg-B / PhysSurg-B
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, physical exercise, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 27 Jan 2016 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether a training program with intensified physical exercise prior to and after surgery for breast cancer enhances postoperative recovery.
Detailed description
This study is designed as a randomised, controlled, non-blinded multicenter trial with two parallell study groups, intervention and control. The primary endpoint of recovery is measured within 12 months after surgery.
After randomisation, participants in the intervention group will be scheduled for an individual consultation with the physiotherapist, where the are advised to increase their Daily physical activiy level with an additional 30 minutes. The added physical activity is registered in an exercise diary daily.
All included participants will be asked to complete questionnaires at inclusion (I), 4 weeks (+/- 1 w) postoperatively (II) and 12 months (+/-1 month) postoperatively (III).
Data regarding patient characteristics, surgical details, postoperative events, complications according to Clavien - Dindo and additional treatment will be collected using eCRF: (I) 30 Days postoperatively, (II) 90 days postoperatively and (III) 12 months postoperatively. Data will also be retrieved from the Swedish National Breast Cancer Register, the Swedish Social Insurance Agency and the Swedish National Death Register.
Patrticipants who wish to be excluded from the study will be asked if already collected data may be analysed in the study.
The code for the study cohort will include personal identity as well as a study specific code. This is placed on a server, with limited access, at Sahlgrenska University Hospital. The database is placed on a server within the University of Gothenburg system accessible with username and code. The database includes only the study specific code for each participant. Data from questionnaires will be entered manually. Length of hospital stay will be acquired from the hospital registries and then entered manually into the database. Data from CRF (I-III) will be entered in the same database, as well as data retrieved from the Swedish National Breast Cancer Register, the National Death Register and Swedish Social Insurance Agency.
In all a high security standard with automatic back up of server data is present as well as firewalls against external violation. A data manager, employed by the SSORG unit will be responsible for the database.
The investigators plan to perform an interim analysis for the first 100 patients included, in order to make a more exact estimate of the power needed. An external monitoring committee will be appointed for the interim analysis, and the question to the committee will be limited to a recalculation of cohort size.The participants will be analysed according to randomisation (intention to treat-type of analysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityIndividual consultation with a physiotherapist in order to increase the participants existing level of physical activity by adding 30minutes of physical activity daily, preoperatively and 4 weeks postoperatively. |
| Control | No intervention | –Participants randomized to the control group will not be advised to change their current level of physical activity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All female patients at the participating hospital scheduled for breast cancer surgery will be asked to participate.
Key exclusion criteria (6 listed)
- Inability to understand given information.
- Inability to perform the intervention, as assessed by the person performing inclusion.
- Withdrawal of informed consent.
- Male sex.
- Stage IV breast cancer at diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityPreoperative intervention - takes place from randomization until surgery (4 weeks +/-2 w): • 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort. Postoperative intervention - takes place from discharge from the hospital until 4 weeks postoperatively: • 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort. Participants randomized to intervention will receive a visit to a physiotherapist for personally adjusted information regarding the intervention, later followed up with a telephone call. | Behavioural | Physical activity |
Primary outcome
Change in self-reported physical and psychological recovery
Time frame: Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively
Measured using validated questions within a questionnaire
Sick leave
Time frame: 12 months postoperatively
Data from the Swedish Social Insurance Agency (Försäkringskassan) on total number of days and the reasons (diagnosis) for any sick-leave episodes
5 secondary outcomes
Length of hospital stay
Time frame: 30 days postoperatively
Adverse events
Time frame: 90 days postoperatively
Re-operations and re-admittances
Time frame: 12 months postoperatively
Mortality
Time frame: 3 and 5 years postoperatively
Health economy
Time frame: 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Derived from this study: PubMed 36113110Heiman J, Onerup A, Bock D, Haglind E, Olofsson Bagge R. The effect of nonsupervised physical activity before and after breast cancer surgery on quality of life: Results from a randomized controlled trial (PhysSURG-B). Scand J Surg. 2022 Dec;111(4):75-82. doi: 10.1177/14574969221123389. Epub 2022 Sep 15.
- Derived from this study: PubMed 33640941Heiman J, Onerup A, Wessman C, Haglind E, Olofsson Bagge R. Recovery after breast cancer surgery following recommended pre and postoperative physical activity: (PhysSURG-B) randomized clinical trial. Br J Surg. 2021 Jan 27;108(1):32-39. doi: 10.1093/bjs/znaa007.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Olofsson Bagge, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported physical and psychological recovery (time frame: Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02560662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.