Clinical trial NCT06076616: Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study
Official title: Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lifestyle
Rehabilitation
Prehabilitation
Surgery
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot study
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment/consent rate
timeFrame: From baseline to 6 months postoperatively
measure: Attendance rate
timeFrame: From baseline to 6 months postoperatively
measure: Patient adherence
timeFrame: From baseline to 6 months postoperatively
measure: Withdrawals
timeFrame: From baseline to 6 months postoperatively
measure: Patient satisfaction
timeFrame: From baseline to 6 months postoperatively
measure: Selection bias
timeFrame: From baseline to 6 months postoperatively
Secondary outcomes:
measure: Likely changes in Health Related Quality of Life (HRQOL)
timeFrame: Baseline, the day before surgery, 6 months postoperatively
measure: Likely changes in BMI
timeFrame: Baseline, the day before surgery, 6 months postoperatively
measure: Likely changes in functional capacity (physical fitness)
timeFrame: Baseline, the day before surgery, 6 months postoperatively
measure: Likely changes in the number of postoperative complications
timeFrame: 30 days after surgery
measure: Likely changes in smoking status
timeFrame: Measured at baseline and 6 months postoperatively
measure: Likely changes in postoperative functional recovery
timeFrame: The day after surgery
measure: Likely changes in mean score of the different BREAST-Q scales
timeFrame: The questionnaire will be administered at enrolment and at six months after surgery.
measure: Likely changes in mean score of quality of life by means of the EORTC-BR23 questionnaire
timeFrame: The questionnaire will be administered at enrolment and at six months after surgery.
measure: Likely changes in mean score of the different EORTC-QLQ-30 scales which will be administered at enrolment and six months after surgery.
timeFrame: The questionnaire will be administered at enrolment and at six months after surgery.
measure: Likely changes in mean score of the EQ5D-5L questionnaire
timeFrame: The questionnaire will be administered at enrolment and at six months after surgery.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis en Vlietland
state: Zuid-Holland
Study officials:
affiliation: Franciscus Gasthuis & Vlietland
name: Taco Klem, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: