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

January 25, 2024 updated by: Roger Olofsson Bagge, Vastra Gotaland Region

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Inclusion, 4 weeks (+/- 1 week) and 12 months (+/- 1 month) postoperatively
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
12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 30 days postoperatively
For each participant the number of days of hospital stay for the index surgery will be collected
30 days postoperatively
Adverse events
Time Frame: 90 days postoperatively
Classified according to Clavien-Dindo
90 days postoperatively
Re-operations and re-admittances
Time Frame: 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
12 months postoperatively
Mortality
Time Frame: 3 and 5 years postoperatively
Data retrieved from National Death Register, overall and cancer-specific mortality
3 and 5 years postoperatively
Health economy
Time Frame: 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.
12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

Scandinavian Surgical Outcomes Research Group

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2016

Primary Completion (Actual)

March 10, 2019

Study Completion (Actual)

February 11, 2020

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimated)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhysSurg-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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