The objectives of the BREHAB pilot study include both process and research objectives. Analysis of the process objectives will enable the feasibility of a larger RCT to be assessed. They focus on the feasibility of prehabilitation and rehabilitation…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pilot study parameters
- 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 and data entered into an excel spreadsheet. We define a success
criterion of 40% of the total number of participants invited to be recruited to
the research evaluation.
- 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.
- 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.
- 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 and entered into an excel spreadsheet.
- 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.
- To investigate likely changes in the primary outcome measure HRQOL measured
with the EORTC-QLQ-30 questionnaire at six months after surgery.
- To investigate likely changes in the secondary outcome measures:
- BMI (kg/cm2) measured at baseline, the day before surgery and at six months
after surgery.
- Functional capacity measured using the 6-minute walking test (6MWT) at
baseline, one day before surgery and at six months after surgery.
- The number of postoperative complications after 30 days measured with the
Comprehensive Complication Index (CCI).
- Smoking status measured at baseline and at six months after surgery.
- Mean score of the different BREAST-Q scales.The questionnaire will be
administered at enrolment and at six months after surgery.
- Mean scores of quality of life by means of the EORTC-BR23 questionnaire,
which will be administered at enrolment and six months after
surgery.
- Mean scores of the different EORTC-QLQ-30 scales which will be administered
at enrolment
and six months after surgery.
Other study parameters:
o Patient age
o Tumor characteristics (ER, PR, HER2NEU receptors, size, BR grade,TNM
classification)
o Type of surgery
o Type of (neo)adjuvant systemic treatment
o Type of radiotherapy
o Type of targeted therapy
o Professional status
o Exercise habits
Secondary outcome
Not applicable
Background summary
Breast cancer is the most common malignancy in women; one in seven women will
develop breast cancer in her lifetime. The diagnosis and treatment of breast
cancer, of which surgery is the cornerstone, have a severe impact on both
physical and mental well-being. Most patients experience a variety of
complaints, such as fatigue, pain, weight gain or loss, anxiety and/or
depressive symptoms, which have a major impact on HRQOL. Moreover, impact of
these complaints is variable.
The benefits of lifestyle interventions, especially multimodal ones, have been
demonstrated by several studies. Diet, exercise and psychological counselling
have positive effects on weight, fatigue, fitness, quality of life and
perioperative outcomes such as post-operative complications and length of
hospitalisation. Multimodal interventions seem to be the most effective.
However, existing rehabilitation and prehabilitation programmes generally
investigate the impact of one specific intervention in relation to one or a few
specific outcomes. This knowledge is often insufficient to create a
personalized treatment plan, given that rehabilitation needs are complex
because patients exhibit a wide range of symptoms with varying impact, and
thereby have specific needs and goals that vary across individuals. Therefore,
a systematic approach to provide individualized rehabilitation is warranted.
Research direction
Standard of care for patients with breast cancer is surgery and (neo)adjuvant
treatment (radiotherapy, chemotherapy, immunotherapy, anti-hormonal therapy).
To decrease the morbidity related to diagnosis and treatment of breast cancer,
an intervention should, in our opinion, be individualized and patient-friendly
in order to achieve better quality of life and satisfaction and a better
prognosis than standard of care. The personalized approach of lifestyle
coaching is ideally suited to the individual needs of patients with breast
cancer.
A pilot study can be used to evaluate the feasibility of recruitment,
assessment procedures, retention, safety and implementation aspects of
lifestyle coaching as an intervention. Inclusion of a control group allows for
a more realistic examination of recruitment, and estimation of effect sizes and
quality of life. A pilot study is also designed to investigate the possible
effects of lifestyle coaching that may be worth following up in a subsequent
larger study. If lifestyle coaching proves to be safe and feasible, and the
methodology (after eventual modifications) is repeatable on a larger scale, the
next step will be to perform a randomised controlled trial to demonstrate the
effectiveness of lifestyle coaching.
Objective of the study: Klik voor meer informatie
The objectives of the BREHAB pilot study include both process and
research objectives. Analysis of the process objectives will enable the
feasibility of a larger RCT to be assessed. They focus on the feasibility of
prehabilitation and rehabilitation through lifestyle coaching, the
acceptability of the intervention and the ability to both recruit and retain
participants in the research evaluation.
This pilot study serves as preparation for a future randomised controlled
trial. Endpoints of the pilot study are: recruitment rate, attendance rate,
adherence, withdrawals, overall satisfaction, evidence of selection bias and
likely changes in primary and secondary outcome measures (HRQOL, BMI, fysical
fitness, complications, smoking status, different domains of the BREAST-Q and
EORTC-BR23 questionnaire and other domains of the EORTC-QLQ-30 questionnaire)
Study objective
The objectives of the BREHAB pilot study include both process and research
objectives. Analysis of the process objectives will enable the feasibility of a
larger RCT to be assessed. They focus on the feasibility of prehabilitation and
rehabilitation through lifestyle coaching, the acceptability of the
intervention and the ability to both recruit and retain participants in the
research evaluation.
This pilot study serves as preparation for a future randomised controlled
trial. Endpoints of the pilot study are: recruitment rate, attendance rate,
adherence, withdrawals, overall satisfaction, evidence of selection bias and
likely changes in primary and secondary outcome measures (HRQOL, BMI, fysical
fitness, complications, smoking status, different domains of the BREAST-Q and
EORTC-BR23 questionnaire and other domains of the EORTC-QLQ-30 questionnaire)
Study design
This study is designed as an open label pilot trial with two arms: an
intervention group and a control group. The interventional arm will receive
lifestyle coaching. The control arm will receive usual care according to the
Dutch breast cancer guideline.
A pilot study is an essential first step in investigating a new intervention. A
pilot study can be used to evaluate the feasibility of recruitment, assessment
procedures, retention, safety and implementation of lifestyle coaching as an
intervention. Inclusion of a control group allows for a more realistic
examination of recruitment and randomization. It is also designed to search for
possible effects of lifestyle coaching that may be worth following up in a
subsequent larger study. If lifestyle coaching proves to be safe and feasible,
and the methodology (after eventual modifications) is repeatable on a larger
scale, the next step will be to perform a randomised controlled trial to
demonstrate the effect of lifestyle coaching.
The study population consists of adult women undergoing surgery for breast
cancer. All eligible patients will consecutively be included and randomised.
Participant*s involvement in the trial is 7 months for patients who do not
undergo neo-adjuvant treatment or 9 months for patients who do undergo
neo-adjuvant treatment. Analysis of clinical outcomes will be undertaken at the
six months follow-up point after surgery for all patients.
Intervention
The intervention consists of prehabilitation and rehabilitation through an
individualised lifestyle coaching programme, starting from diagnosis up to 6
months postoperatively.
Lifestyle coaching will be performed by a lifestyle coach certified by the
official Dutch association of lifestyle coaches (in Dutch: BLCN:
Beroepsvereniging Leefstijlcoaches Nederland). In addition, the lifestyle coach
has advanced experience in the treatment of patients with breast cancer.
Lifestyle coaching will be conducted in a private consulting room or in home
environment, according to the patients preference.
The aim of lifestyle coaching is to outline all aspects of lifestyle (such as
nutrition, exercise, smoking, alcohol consumption, stress and sleep) and
determine which aspects can be improved for the patient. The patient is guided
in making her own choices without imposing choices.
Study burden and risks
Additional interventions that will be performed comprise the investigational
treatment (within 1-2 week[s] after diagnosis), which includes lifestyle
coaching. Potential burden and risks: discomfort, physical injuries (low risk)
or barriers due to physical exercise.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82852.100.22 |