Patient-centered Breast Cancer Teleprehabilitation
- Conditions
- Breast NeoplasmsBreast CancerSurgery
- Interventions
- Behavioral: Patient-centered teleprehabilitation
- Registration Number
- NCT05782504
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 50
- Aged 18 years or older
- Scheduled for primary breast surgery because of stage I-III breast cancer
- Able to speak and read Dutch fluently
- Stage IV breast cancer
- A medical contra-indication for physical activity
- Not being able to access a computer or mobile device at home
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm Patient-centered teleprehabilitation 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.
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (safety and tolerability) within one week after completion of the intervention 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.
Patient satisfaction with the teleprehabilitation intervention (feeling of contentment with the intervention) within one week after completion of 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.
Adherence to treatment (compliance rate) within one week after completion of the intervention 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.
Feasibility of teleprehabilitation in the clinical setting by means of focus group discussions with stakeholders through study completion, an average of 1 year 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.
Participation rate one day before the start of the intervention 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.
- Secondary Outcome Measures
Name Time Method Healthcare and medication use during the study period 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 healthcare and medication use during the study period, including the use of co-interventions, will be registered with a modified version of the Medical Consumption Questionnaire. This is a generic instrument for measuring the patients' total medical consumption, including additional diagnostics, healthcare visits, hospitalization, physiotherapy, medication, and aids (prescribed by the general practitioner or purchased by the patients themselves).
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 The Brief Pain Inventory (BPI) is a 14-item questionnaire developed by the World Health Organization Collaborating Centre for Symptom Evaluation in Cancer Care to assess the worst pain, pain severity, and pain interference in cancer patients over the past week reported on a scale of 0 to 10. Pain interference is measured as the average of the 7 interference items, such as walking, mood, and sleep. The BPI is the most common, reliable, and valid outcome measure to assess pain in cancer patients (Cronbach's a and test-retest reliability score \> 0.80).
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 Physical activity of the participants will be assessed with the short form of the International Physical Activity Questionnaire (IPAQ-SF), which subjectively assesses physical activity over the past 7 days. The Dutch version of the IPAQ shows good reliability and validity.
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 For measuring the feeling of perceived injustice, the Injustice Experience Questionnaire (IEQ) will be used. Participants have to rate the frequency of 12 different statements on a 5-point Likert scale ranging from 0 (not at all) to 4 (all the time), giving a total score that ranges from 0 to 48. The Dutch version of the IEQ is valid and has good (test-retest) reliability (ICC = 0.86-0.87).
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 Fatigue is one of the most debilitating symptoms in patients with breast cancer and is the most commonly included cancer-related symptom in core outcome sets for cancer research. For measuring fatigue, the general fatigue subscale of the Multidimensional Fatigue Inventory (MFI-20), a 20-item self-report instrument, will be used. The Dutch MFI-20 is a valid tool to assess cancer-related fatigue in breast cancer patients receiving oncological treatment. This scale has a score from 20 to 100: higher scores indicate a higher level of fatigue.
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 The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) is a 30-item cancer-specific questionnaire developed for the assessment of the quality of life in cancer patients. The EORTC QLQ-C30 is the most commonly used patient-reported outcome in breast cancer studies, has been translated and validated in over 100 languages, and shows acceptable psychometric properties. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Self-efficacy (self-beliefs to cope with a variety of difficult demands in life) 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 General Self-Efficacy Scale is a short 10-item scale for assessing optimistic self-beliefs to cope with a variety of difficult demands in life (such as cancer and its treatment), which is widely used, translated, and validated in many languages. This scale has a score from 0 to 90: a higher number on this scale means higher self-efficacy.
Trial Locations
- Locations (2)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Belgium
Universitair Ziekenhuis Brussel
🇧🇪Jette, Brussels, Belgium