Patient-centered Breast Cancer Teleprehabilitation

Breast Cancer Clinical Trial

— BC-PREHAB  

Official title:

Patient-centered Teleprehabilitation for Women With Breast Cancer: a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782504
• Other study ID #: KOTK/2022/12550
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2023
• Source: Universitair Ziekenhuis Brussel
• Contact: Kenza Mostaqim, Dra.
• Phone: +3224774503
• Email: Kenza.Mostaqim[@]vub.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Surgery

Intervention

Behavioral:
• Patient-centered teleprehabilitation
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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (5)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	Hasselt University, Kom Op Tegen Kanker, Vrije Universiteit Brussel, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Fatigue (feeling of tiredness or lack of energy)	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.	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
Secondary	Pain (uncomfortable sensations in the body)	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).	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
Secondary	Quality of Life (the degree to which an individual is healthy, comfortable, and able to participate in or enjoy life events)	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.	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
Secondary	Subjective level of physical activity	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.	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
Secondary	The feeling of perceived injustice	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).	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
Secondary	Self-efficacy (self-beliefs to cope with a variety of difficult demands in life)	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.	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
Secondary	Healthcare and medication use during the study period	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).	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