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

NCT06076616 | Completed

• 1 other identifier: 2022-097
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Lifestyle; Rehabilitation; Prehabilitation; Surgery

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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.

  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.

  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.

  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).

  From baseline to 6 months postoperatively

Secondary Outcomes (10)

• Likely changes in Health Related Quality of Life (HRQOL)

  Baseline, the day before surgery, 6 months postoperatively

• Likely changes in BMI

  Baseline, the day before surgery, 6 months postoperatively

• Likely changes in functional capacity (physical fitness)

  Baseline, the day before surgery, 6 months postoperatively

• Likely changes in the number of postoperative complications

  30 days after surgery

• Likely changes in smoking status

  Measured at baseline and 6 months postoperatively

Study Arms (2)

Prehabilitation/rehabilitation

EXPERIMENTAL

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

Behavioral: Prehabilitation and rehabilitation

Usual care

NO INTERVENTION

Patients in this arm follow usual care.

Interventions

Prehabilitation and rehabilitation BEHAVIORAL

A personalized lifestyle counseling programme.

Prehabilitation/rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Franciscus Gasthuis: lead

Study Sites (1)

Franciscus Gasthuis en Vlietland

Rotterdam, South Holland, 3045PM, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Preoperative Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care

Study Officials

• Taco Klem, MD,PHD

  Franciscus Gasthuis & Vlietland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A pilot study

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: October 11, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)