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

NCT ID: NCT06076616

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-01-01

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer Lifestyle Rehabilitation Prehabilitation Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prehabilitation/rehabilitation

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

Group Type EXPERIMENTAL

Prehabilitation and rehabilitation

Intervention Type BEHAVIORAL

A personalized lifestyle counseling programme.

Usual care

Patients in this arm follow usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prehabilitation and rehabilitation

A personalized lifestyle counseling programme.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Franciscus Gasthuis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taco Klem, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Franciscus Gasthuis & Vlietland

Locations

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Franciscus Gasthuis en Vlietland

Rotterdam, South Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2022-097

Identifier Type: -

Identifier Source: org_study_id

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