Skip to main content
OpenTrials
Completed

NCT Number: NCT06076616

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Lifestyle Neoplasms Neoplasms by Site Prehabilitation Rehabilitation Skin Diseases Skin and Connective Tissue Diseases Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Franciscus Gasthuis en Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Woman with a confirmed breast cancer diagnosis
  • Planned surgical treatment of breast cancer
  • Age 18 years or older
  • Provision of written informed consent

Exclusion criteria

  • Severe mental retardation, which limits the ability to follow instructions independently
  • Severe psychiatric problems, which limits the ability to follow instructions independently
  • Legal incapacity
  • 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.

Treatment and study plan

Prehabilitation and rehabilitation

Behavioral

A personalized lifestyle counseling programme.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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).

Secondary outcomes

  1. 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.

  2. Likely changes in BMI

    Time frame: Baseline, the day before surgery, 6 months postoperatively

    Body Mass Index

  3. 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)

  4. 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)

  5. Likely changes in smoking status

    Time frame: Measured at baseline and 6 months postoperatively

    Smoking status (yes/no) as assessed by the primary investigator

  6. Likely changes in postoperative functional recovery

    Time frame: The day after surgery

    Measured the day after surgery with the MILAS and DEMMI questionnaires

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Franciscus Gasthuis

Other

Registry information

Acronym: BREHAB

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 11, 2023
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.