Clinical trial NCT02560662: PhysSurg-B : Physical Activity in Relation to Surgical Operations - Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer, physical exercise, recovery
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2015-09-25
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* All female patients at the participating hospital scheduled for breast cancer surgery will be asked to participate.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in self-reported physical and psychological recovery
timeFrame: Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively
measure: Sick leave
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 30 days postoperatively
measure: Adverse events
timeFrame: 90 days postoperatively
measure: Re-operations and re-admittances
timeFrame: 12 months postoperatively
measure: Mortality
timeFrame: 3 and 5 years postoperatively
measure: Health economy
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska University Hospital
name: Roger Olofsson Bagge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Heiman 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.