Viewing Study NCT05782504


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Ignite Modification Date: 2025-12-25 @ 7:04 PM
Study NCT ID: NCT05782504
Status: UNKNOWN
Last Update Posted: 2023-03-23
First Post: 2023-02-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Patient-centered Breast Cancer Teleprehabilitation
Sponsor: Universitair Ziekenhuis Brussel
Organization:

Study Overview

Official Title: Patient-centered Teleprehabilitation for Women With Breast Cancer: a Feasibility Study
Status: UNKNOWN
Status Verified Date: 2023-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BC-PREHAB
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: