Clinical trial NCT05782504: Patient-centered Breast Cancer Teleprehabilitation
Official title: Patient-centered Teleprehabilitation for Women With Breast Cancer: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Breast Neoplasms
Surgery
Keywords: Prehabilitation
Teleprehabilitation
Breast cancer surgery
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Ziekenhuis Oost-Limburg
name: Hasselt University
name: Kom Op Tegen Kanker
First posted: 2023-03-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal, single-arm, mixed-methods
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Participation rate
timeFrame: one day before the start of the intervention
measure: Patient satisfaction with the teleprehabilitation intervention (feeling of contentment with the intervention)
timeFrame: within one week after completion of the intervention
measure: Incidence of treatment-emergent adverse events (safety and tolerability)
timeFrame: within one week after completion of the intervention
measure: Adherence to treatment (compliance rate)
timeFrame: within one week after completion of the intervention
measure: Feasibility of teleprehabilitation in the clinical setting by means of focus group discussions with stakeholders
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Fatigue (feeling of tiredness or lack of energy)
timeFrame: 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
measure: Pain (uncomfortable sensations in the body)
timeFrame: 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
measure: Quality of Life (the degree to which an individual is healthy, comfortable, and able to participate in or enjoy life events)
timeFrame: 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
measure: Subjective level of physical activity
timeFrame: 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
measure: The feeling of perceived injustice
timeFrame: 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
measure: Self-efficacy (self-beliefs to cope with a variety of difficult demands in life)
timeFrame: 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
measure: Healthcare and medication use during the study period
timeFrame: 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
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, Prof. Dr
role: PRINCIPAL_INVESTIGATOR
References: