Breast CancerBREHABNCT06076616
Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study
A study testing Prehabilitation and rehabilitation in people with Breast Cancer and Lifestyle, run by Franciscus Gasthuis at 1 site in Netherlands.
Trial summary
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Lifestyle, Rehabilitation
- What is being tested?
- Prehabilitation and rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2022to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman with a confirmed breast cancer diagnosis
- Planned surgical treatment of breast cancer
- Age 18 years or older
- Provision of written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Franciscus Gasthuis en Vlietland
Rotterdam, South Holland, 3045PM
About this study
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.
- Conditions
- Breast Cancer, Lifestyle, Rehabilitation, Prehabilitation, Surgery
- Being tested
- Prehabilitation and rehabilitation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation and rehabilitationBehavioural
A personalized lifestyle counseling programme.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation/rehabilitation | Experimental | Patients in this arm follow a lifestyle counseling programme starting from diagnosis up to 6 months postoperatively. Receives: Behavioral: Prehabilitation and rehabilitation |
| Usual care | No intervention | Patients in this arm follow usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From baseline to 6 months postoperatively
Secondary outcomes (10)
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.
Measured: Baseline, the day before surgery, 6 months postoperatively
Likely changes in BMI
Body Mass Index
Measured: Baseline, the day before surgery, 6 months postoperatively
Likely changes in functional capacity (physical fitness)
Measured using the 6 minute walking test (6MWT)
Measured: 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)
Measured: 30 days after surgery
Likely changes in smoking status
Smoking status (yes/no) as assessed by the primary investigator
Measured: Measured at baseline and 6 months postoperatively
Likely changes in postoperative functional recovery
Measured the day after surgery with the MILAS and DEMMI questionnaires
Measured: The day after surgery
Likely changes in mean score of the different BREAST-Q scales
Measured using the BREAST-Q questionnaire
Measured: 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
Measured: 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
Measured: 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
Measured: The questionnaire will be administered at enrolment and at six months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taco Klem, MD,PHD, Principal investigator, Franciscus Gasthuis & Vlietland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076616
- Sponsor's protocol ID
- 2022-097
- Acronym
- BREHAB
- Status last verified
- May 2024
- First submitted
- 6 Dec 2022
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT06076616
- Acronym / sponsor ID
- BREHAB / 2022-097
- Conditions
- Breast Cancer, Lifestyle, Rehabilitation, Prehabilitation, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prehabilitation and rehabilitation through personalized lifestyle counseling in patients with breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pilot study
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation/rehabilitation | Experimental | Behavioral: Prehabilitation and rehabilitationPatients in this arm follow a lifestyle counseling programme starting from diagnosis up to 6 months postoperatively. |
| Usual care | No intervention | –Patients in this arm follow usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Woman with a confirmed breast cancer diagnosis
- Planned surgical treatment of breast cancer
- Age 18 years or older
- Provision of written informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation and rehabilitationA personalized lifestyle counseling programme. | Behavioural | Prehabilitation/rehabilitation |
Primary outcome
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.
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
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.
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.
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.
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).
10 secondary outcomes
Likely changes in Health Related Quality of Life (HRQOL)
Time frame: Baseline, the day before surgery, 6 months postoperatively
Likely changes in BMI
Time frame: 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
Likely changes in the number of postoperative complications
Time frame: 30 days after surgery
Likely changes in smoking status
Time frame: Measured at baseline and 6 months postoperatively
Likely changes in postoperative functional recovery
Time frame: 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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity
Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taco Klem, MD,PHD principal investigator
Franciscus Gasthuis & Vlietland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation and rehabilitation in people with Breast Cancer and Lifestyle, run by Franciscus Gasthuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment/consent rate (time frame: From baseline to 6 months postoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.