Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study (BREHAB)

May 14, 2024 updated by: Franciscus Gasthuis
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3045PM
        • Franciscus Gasthuis en Vlietland

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Woman with a confirmed breast cancer diagnosis
  2. Planned surgical treatment of breast cancer
  3. Age 18 years or older
  4. Provision of written informed consent

Exclusion criteria

  1. Severe mental retardation, which limits the ability to follow instructions independently
  2. Severe psychiatric problems, which limits the ability to follow instructions independently
  3. Legal incapacity
  4. Language barrier: If we cannot find a lifestyle coach who speaks the patient's language, unfortunately we cannot offer the lifestyle coaching in its entirety, and this option will be omitted for the patient.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prehabilitation/rehabilitation
Patients in this arm follow a lifestyle counseling programme starting from diagnosis up to 6 months postoperatively.
Behavioral: Prehabilitation and rehabilitation
A personalized lifestyle counseling programme.
No Intervention: Usual care
Patients in this arm follow usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment/consent rate
Time Frame: From baseline to 6 months postoperatively
To estimate patient recruitment/consent rate to the prehabilitation/rehabilitation group Enrolment logs will be recorded for all patients who meet the eligibility criteria. Reasons for non-participation will be recorded. We define a success criterion of 40% of the total number of participants invited to be recruited to the pilot study.
From baseline to 6 months postoperatively
Attendance rate
Time Frame: From baseline to 6 months postoperatively
To estimate patient attendance, measured by the number of sessions attended out of 10. Reasons for non-attendance will be collected and withdrawals tracked. We will consider an attendance rate of 80% satisfactory
From baseline to 6 months postoperatively
Patient adherence
Time Frame: From baseline to 6 months postoperatively
To estimate patient adherence monitored with the aid of the wearables. Adherence is defined as at least 150 min of moderate intensity exercise and at least two strength training sessions per week. Exercise instructions are based on the Health Council's exercise guidelines. We will consider an adherence of 70% as satisfactory.
From baseline to 6 months postoperatively
Withdrawals
Time Frame: From baseline to 6 months postoperatively
To estimate the number of withdrawals, defined as the proportion of patients who quit the intervention before reaching the primary endpoint (HRQOL at six months after surgery). Information about the reasons for withdrawal will be collected.
From baseline to 6 months postoperatively
Patient satisfaction
Time Frame: From baseline to 6 months postoperatively
To estimate patient satisfaction with the programme assessed during three interviews: at four weeks, at three months after surgery and at the end of the study. Satisfaction is defined as: satisfaction with the lifestyle coach, satisfaction with the duration of the intervention, satisfaction with the physical training programme. Patients will be given room for their own input to improve the intervention.
From baseline to 6 months postoperatively
Selection bias
Time Frame: From baseline to 6 months postoperatively
To explore any evidence of selection bias in participants recruited into the study (assessed through participant characteristics at baseline).
From baseline to 6 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Likely changes in Health Related Quality of Life (HRQOL)
Time Frame: Baseline, the day before surgery, 6 months postoperatively
To investigate likely changes in the primary outcome measure HRQOL measured with the EORTC-QLQ-30 questionnaire at six months after surgery.
Baseline, the day before surgery, 6 months postoperatively
Likely changes in BMI
Time Frame: Baseline, the day before surgery, 6 months postoperatively
Body Mass Index
Baseline, the day before surgery, 6 months postoperatively
Likely changes in functional capacity (physical fitness)
Time Frame: Baseline, the day before surgery, 6 months postoperatively
Measured using the 6 minute walking test (6MWT)
Baseline, the day before surgery, 6 months postoperatively
Likely changes in the number of postoperative complications
Time Frame: 30 days after surgery
Complications within 30 days after surgery, measured with the Comprehensive Complication Index (CCI)
30 days after surgery
Likely changes in smoking status
Time Frame: Measured at baseline and 6 months postoperatively
Smoking status (yes/no) as assessed by the primary investigator
Measured at baseline and 6 months postoperatively
Likely changes in postoperative functional recovery
Time Frame: The day after surgery
Measured the day after surgery with the MILAS and DEMMI questionnaires
The day after surgery
Likely changes in mean score of the different BREAST-Q scales
Time Frame: The questionnaire will be administered at enrolment and at six months after surgery.
Measured using the BREAST-Q questionnaire
The questionnaire will be administered at enrolment and at six months after surgery.
Likely changes in mean score of quality of life by means of the EORTC-BR23 questionnaire
Time Frame: The questionnaire will be administered at enrolment and at six months after surgery.
Measured using the EORTC-BR23 questionnaire
The questionnaire will be administered at enrolment and at six months after surgery.
Likely changes in mean score of the different EORTC-QLQ-30 scales which will be administered at enrolment and six months after surgery.
Time Frame: The questionnaire will be administered at enrolment and at six months after surgery.
Measured using the EORTC-QLQ-30 questionnaire
The questionnaire will be administered at enrolment and at six months after surgery.
Likely changes in mean score of the EQ5D-5L questionnaire
Time Frame: The questionnaire will be administered at enrolment and at six months after surgery.
Measured using the EQ-5D-5L questionnaire
The questionnaire will be administered at enrolment and at six months after surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Franciscus Gasthuis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Taco Klem, MD,PHD, Franciscus Gasthuis & Vlietland

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-097

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings