Prehabilitation and Rehabilitation in Breast Cancer Surgery Patients - a Pilot Study - Clinical Trial for Breast Cancer | NCT06076616

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Prehabilitation and rehabilitation

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Franciscus Gasthuis en VlietlandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prehabilitation/rehabilitation

Usual care

Arm Description

Patients in this arm follow a lifestyle counseling programme starting from diagnosis up to 6 months postoperatively.

Patients in this arm follow usual care.

Outcomes

Primary Outcome Measures

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.

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

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.

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.

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.

Selection bias

To explore any evidence of selection bias in participants recruited into the study (assessed through participant characteristics at baseline).

Secondary Outcome Measures

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.

Likely changes in BMI

Body Mass Index

Likely changes in functional capacity (physical fitness)

Measured using the 6 minute walking test (6MWT)

Likely changes in the number of postoperative complications

Complications within 30 days after surgery, measured with the Comprehensive Complication Index (CCI)

Likely changes in smoking status

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

Likely changes in postoperative functional recovery

Measured the day after surgery with the MILAS and DEMMI questionnaires

Likely changes in mean score of the different BREAST-Q scales

Measured using the BREAST-Q questionnaire

Likely changes in mean score of quality of life by means of the EORTC-BR23 questionnaire

Measured using the EORTC-BR23 questionnaire

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

Likely changes in mean score of the EQ5D-5L questionnaire

Measured using the EQ-5D-5L questionnaire

Full Information

NCT ID

NCT06076616

First Posted

December 6, 2022

Last Updated

October 3, 2023

Sponsor

Franciscus Gasthuis

1. Study Identification

Unique Protocol Identification Number

NCT06076616

Brief Title

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

Acronym

BREHAB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Franciscus Gasthuis

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Lifestyle, Rehabilitation, Prehabilitation, Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A pilot study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prehabilitation/rehabilitation

Arm Type

Experimental

Arm Description

Patients in this arm follow a lifestyle counseling programme starting from diagnosis up to 6 months postoperatively.

Arm Title

Usual care

Arm Type

No Intervention

Arm Description

Patients in this arm follow usual care.

Intervention Type

Behavioral

Intervention Name(s)

Prehabilitation and rehabilitation

Intervention Description

A personalized lifestyle counseling programme.

Primary Outcome Measure Information:

Title

Recruitment/consent rate

Description

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.

Time Frame