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Trial Title:
Patient-centered Breast Cancer Teleprehabilitation
NCT ID:
NCT05782504
Condition:
Breast Cancer
Breast Neoplasms
Surgery
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Prehabilitation
Teleprehabilitation
Breast cancer surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Longitudinal, single-arm, mixed-methods
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient-centered teleprehabilitation
Description:
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.
Arm group label:
Treatment arm
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitair Ziekenhuis Brussel
Address:
City:
Jette
Zip:
1020
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Jo Nijs, Prof. Dr.
Facility:
Name:
Ziekenhuis Oost-Limburg
Address:
City:
Genk
Zip:
3600
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Eric de Jonge, Dr.
Start date:
January 30, 2023
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Universitair Ziekenhuis Brussel
Agency class:
Other
Collaborator:
Agency:
Vrije Universiteit Brussel
Agency class:
Other
Collaborator:
Agency:
Ziekenhuis Oost-Limburg
Agency class:
Other
Collaborator:
Agency:
Hasselt University
Agency class:
Other
Collaborator:
Agency:
Kom Op Tegen Kanker
Agency class:
Other
Source:
Universitair Ziekenhuis Brussel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05782504
