PhysSurg-B : Physical Activity in Relation to Surgical Operations - Breast Cancer

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT02560662

Collaborator

Scandinavian Surgical Outcomes Research Group (Other)

400

Enrollment

Location

Arms

48.5

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Physical activity	N/A

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

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 27, 2016

Actual Primary Completion Date :

Mar 10, 2019

Actual Study Completion Date :

Feb 11, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Physical activity 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.	Behavioral: Physical activity 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.
No Intervention: Control Participants randomized to the control group will not be advised to change their current level of physical activity.

Arm

Intervention/Treatment

Experimental: Physical activity

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.

Behavioral: Physical activity

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.

No Intervention: Control

Participants randomized to the control group will not be advised to change their current level of physical activity.

Outcome Measures

Primary Outcome Measures

Change in self-reported physical and psychological recovery [Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively]
Measured using validated questions within a questionnaire
Sick leave [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

Secondary Outcome Measures

Length of hospital stay [30 days postoperatively]
For each participant the number of days of hospital stay for the index surgery will be collected
Adverse events [90 days postoperatively]
Classified according to Clavien-Dindo
Re-operations and re-admittances [12 months postoperatively]
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
Mortality [3 and 5 years postoperatively]
Data retrieved from National Death Register, overall and cancer-specific mortality
Health economy [12 months postoperatively]
Analysis using modelling, focusing on the societal perspective and measuring the effects of regular physical exercise for resource consumption, measured in Swedish currency SEK.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sahlgrenska University Hospital	Gothenburg		Sweden	413 45

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden
Scandinavian Surgical Outcomes Research Group

Investigators

Principal Investigator: Roger Olofsson Bagge, MD, PhD, Sahlgrenska University Hospital, Sweden

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Roger Olofsson Bagge, MD, PhD, MD, PhD, Sahlgrenska University Hospital, Sweden

ClinicalTrials.gov Identifier:

NCT02560662

Other Study ID Numbers:

PhysSurg-B

First Posted:

Sep 25, 2015

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Roger Olofsson Bagge, MD, PhD, MD, PhD, Sahlgrenska University Hospital, Sweden

Breast cancer, physical exercise, recovery

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Oct 22, 2020