Patient-centered Breast Cancer Teleprehabilitation

NCT ID: NCT05782504

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2024-08-31

Brief Summary

Surgery, the cornerstone of most cancer treatments, is associated with considerable postoperative complications. Adjusting patients' health behavior before surgery may have beneficial effects on postoperative outcomes.

Women (n=50) who will undergo breast surgery because of stage I-III breast cancer are eligible. All participants will receive multimodal patient-centered teleprehabilitation comprising of motivational interviewing, education, exercise therapy, and stress management.

Detailed Description

Feasibility, participation rate, patient satisfaction, intervention safety, and treatment adherence will be monitored as primary outcomes. Fatigue, pain, quality of life (QoL), physical activity levels, perceived injustice, self-efficacy, and healthcare use are secondary outcomes and will be assessed by self-reported questionnaires at baseline, 0-, 2-, and 6 months post-intervention.

Proof of concept for using telecommunication and exercise therapy in prehabilitation prior to breast cancer surgery is available. We expect the proposed intervention to be feasible and effective at reducing fatigue, pain, perceived injustice, and healthcare use, and at improving treatment adherence, QoL, physical activity levels, and self-efficacy.

Effective prehabilitation interventions can reduce the long-term symptoms that arise/persist beyond treatment completion, improving patients' QoL. By using telecommunication technologies, socio-economic barriers can be reduced, making care accessible to all.

Conditions

Breast Cancer; Breast Neoplasms; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

4 treatment sessions, each lasting 60 minutes, within a 4-week perioperative period, with 2 preoperative (in the last 2 weeks before surgery) and 2 postoperative (in the first 2 weeks after surgery) sessions.

Group Type: EXPERIMENTAL

Patient-centered teleprehabilitation

Intervention Type: BEHAVIORAL

Education about the consequences of stress and low physical activity levels with examples of how improving stress tolerance and physical activity can influence QoL and oncological treatment outcomes.

Exercise therapy based on shared-decision making and using a patient-centered approach. The goal will be to strive for 150-220 min. of moderate physical activity/week, including a home exercise program (at least 1 session/week) of 30-45 min. moderate aerobic exercise, 20 min. of strength training and 10 min. cool down. The latter is guided by Physitrack software.

Stress management, including questioning personal stress experiences and perceptions, relevant stressors, and stress coping strategies. Next, 3 different relaxation strategies will be explained. Also, cognitive-emotional approaches to stress management and identification of uplifts will be introduced.

Motivational interviewing will be used during the whole intervention.

Interventions

Patient-centered teleprehabilitation

Education about the consequences of stress and low physical activity levels with examples of how improving stress tolerance and physical activity can influence QoL and oncological treatment outcomes.

Exercise therapy based on shared-decision making and using a patient-centered approach. The goal will be to strive for 150-220 min. of moderate physical activity/week, including a home exercise program (at least 1 session/week) of 30-45 min. moderate aerobic exercise, 20 min. of strength training and 10 min. cool down. The latter is guided by Physitrack software.

Stress management, including questioning personal stress experiences and perceptions, relevant stressors, and stress coping strategies. Next, 3 different relaxation strategies will be explained. Also, cognitive-emotional approaches to stress management and identification of uplifts will be introduced.

Motivational interviewing will be used during the whole intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 18 years or older
• Scheduled for primary breast surgery because of stage I-III breast cancer
• Able to speak and read Dutch fluently

Exclusion Criteria

• Stage IV breast cancer
• A medical contra-indication for physical activity
• Not being able to access a computer or mobile device at home

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: collaborator

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Nijs, Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Kenza Mostaqim, Dra.

Role: CONTACT

Kenza.Mostaqim@vub.be

+3224774503

Eva Huysmans, Dr.

Role: CONTACT

Eva.Huysmans@vub.be

+3224774503

Facility Contacts

Jo Nijs, Prof. Dr.

Role: primary

Eric de Jonge, Dr.

Role: primary

Other Identifiers

KOTK/2022/12550

Identifier Type: -

Identifier Source: org_study_id