Breast CancerBC-PREHABNCT05782504
Patient-centered Breast Cancer Teleprehabilitation
A study testing Patient-centered teleprehabilitation in people with Breast Cancer and Breast Neoplasms, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Surgery
- What is being tested?
- Patient-centered teleprehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesBelgium
- Study dates
- 30 Jan 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Scheduled for primary breast surgery because of stage I-III breast cancer
- Able to speak and read Dutch fluently
Who cannot join
- Stage IV breast cancer
- A medical contra-indication for physical activity
- Not being able to access a computer or mobile device at home
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Eric de Jonge, Dr.
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1020
Jo Nijs, Prof. Dr.
About this study
Official title: Patient-centered Teleprehabilitation for Women With Breast Cancer: a Feasibility Study
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Neoplasms, Surgery
- Being tested
- Patient-centered teleprehabilitation
- Keywords
- Prehabilitation, Teleprehabilitation, Breast cancer surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered teleprehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient-centered teleprehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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).
Measured: 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
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.
Measured: 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
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start30 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal, single-arm, mixed-methods
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Ziekenhuis Oost-Limburg, Hasselt University, Kom Op Tegen Kanker
- Responsible party
- Sponsor
- Investigators
- Jo Nijs, Prof. Dr, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782504
- Sponsor's protocol ID
- KOTK/2022/12550
- Acronym
- BC-PREHAB
- Status last verified
- Jan 2023
- First submitted
- 8 Feb 2023
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Teleprehabilitation for Women With Breast Cancer: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05782504
- Acronym / sponsor ID
- BC-PREHAB / KOTK/2022/12550
- Conditions
- Breast Cancer, Breast Neoplasms, Surgery
- Keywords
- Prehabilitation, Teleprehabilitation, Breast cancer surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, Ziekenhuis Oost-Limburg, Hasselt University, Kom Op Tegen Kanker
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal, single-arm, mixed-methods
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Behavioral: Patient-centered teleprehabilitation4 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Scheduled for primary breast surgery because of stage I-III breast cancer
- Able to speak and read Dutch fluently
Key exclusion criteria (3 listed)
- Stage IV breast cancer
- A medical contra-indication for physical activity
- Not being able to access a computer or mobile device at home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-centered teleprehabilitationEducation 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. | Behavioural | Treatment arm |
Primary outcome
Participation rate
Time frame: 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.
Patient satisfaction with the teleprehabilitation intervention (feeling of contentment with the intervention)
Time frame: 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.
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: 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.
Adherence to treatment (compliance rate)
Time frame: 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
Time frame: 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.
7 secondary outcomes
Fatigue (feeling of tiredness or lack of energy)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Self-efficacy (self-beliefs to cope with a variety of difficult demands in life)
Time frame: 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
Healthcare and medication use during the study period
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Nijs, Prof. Dr principal investigator
Vrije Universiteit Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centered teleprehabilitation in people with Breast Cancer and Breast Neoplasms, run by Universitair Ziekenhuis Brussel at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenza Mostaqim, Dra. (+3224774503, Kenza.Mostaqim@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate (time frame: one day before the start of the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.