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

Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Surgery; Rehabilitation; Lifestyle; Prehabilitation
• Intervention / Treatment: Behavioral: Prehabilitation and rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Recruitment/consent rate	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Likely changes in Health Related Quality of Life (HRQOL)	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	Body Mass Index	Baseline, the day before surgery, 6 months postoperatively
Likely changes in functional capacity (physical fitness)	Measured using the 6 minute walking test (6MWT)	Baseline, the day before surgery, 6 months postoperatively
Likely changes in the number of postoperative complications	Complications within 30 days after surgery, measured with the Comprehensive Complication Index (CCI)	30 days after surgery
Likely changes in smoking status	Smoking status (yes/no) as assessed by the primary investigator	Measured at baseline and 6 months postoperatively
Likely changes in postoperative functional recovery	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	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	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.	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	Measured using the EQ-5D-5L questionnaire	The questionnaire will be administered at enrolment and at six months after surgery.

Collaborators and Investigators

• Sponsor: Franciscus Gasthuis
• Investigators: Principal Investigator: Taco Klem, MD,PHD, Franciscus Gasthuis & Vlietland

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID 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