Patient-centered Breast Cancer Teleprehabilitation

NCT05782504 | Unknown DMC

• 1 other identifier: KOTK/2022/12550
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Breast Neoplasms; Surgery

Keywords

Prehabilitation; Teleprehabilitation; Breast cancer surgery

Outcome Measures

Primary Outcomes (5)

• Participation rate

  This will be calculated as the ratio of the number of patients participating in the study to the number of patients eligible for study participation. Along with that, the participation rate for each of the secondary outcome measures (see further) at each of the time points (baseline and follow-up) will be recorded.

  one day before the start of the intervention

• Patient satisfaction with the teleprehabilitation intervention (feeling of contentment with the intervention)

  This will be assessed using a questionnaire ending with an open question ('To what extent is this what you needed? Please explain your answer') and the possibility to suggest alternative treatment content. Patient satisfaction with teleprehabilitation will also be assessed using in-depth interviews with all study participants.

  within one week after completion of the intervention

• Incidence of treatment-emergent adverse events (safety and tolerability)

  To examine the safety of the intervention, participants will be asked whether they experienced any side effects or unexpected events associated with the intervention after each treatment session.

  within one week after completion of the intervention

• Adherence to treatment (compliance rate)

  The compliance rate for the teleprehabilitation sessions will be calculated as the ratio of the number of followed treatment sessions versus the number of planned treatment sessions. Next to the supervised sessions, patients will also have sessions without direct supervision that they will have to carry out themselves at home (i.e., exercise sessions, relaxation exercises, and reading the information leaflet). Patients will be asked to record these unsupervised therapy sessions in a personal logbook. The compliance with these home exercise sessions is calculated as the ratio between the number of sessions performed and the number of sessions prescribed.

  within one week after completion of the intervention

• Feasibility of teleprehabilitation in the clinical setting by means of focus group discussions with stakeholders

  The feasibility of the patient-centered teleprehabilitation intervention in the clinical setting will be investigated using focus group discussions with all the involved care providers.

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Fatigue (feeling of tiredness or lack of energy)

  one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery

• Pain (uncomfortable sensations in the body)

  one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery

• Quality of Life (the degree to which an individual is healthy, comfortable, and able to participate in or enjoy life events)

  one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery

• Subjective level of physical activity

  one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery

• The feeling of perceived injustice

  one day before the start of the intervention, one week after completion of the intervention, 30 days after breast surgery, 6 months after breast surgery

Study Arms (1)

Treatment arm

EXPERIMENTAL

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.

Behavioral: Patient-centered teleprehabilitation

Interventions

Patient-centered teleprehabilitation 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.

Treatment arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator
• Ziekenhuis Oost-Limburg: collaborator
• Hasselt University: collaborator
• Kom Op Tegen Kanker: collaborator

Study Sites (2)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1020, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jo Nijs, Prof. Dr

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kenza Mostaqim, Dra.

CONTACT

+3224774503; Kenza.Mostaqim@vub.be

Eva Huysmans, Dr.

CONTACT

+3224774503; Eva.Huysmans@vub.be

Study Design

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

Model Details: Longitudinal, single-arm, mixed-methods

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 23, 2023
• Study Start: January 30, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)