Breast CancerPECANNCT06308029
Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
A study testing eHealth self-management support program and Face-to-face rehabilitation program in people with Breast Cancer, run by Universiteit Antwerpen at 2 sites in Belgium.
Trial summary
The scientific goals of the project are: 1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to: usual care (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- eHealth self-management support program and Face-to-face rehabilitation program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesBelgium
- Study dates
- 26 May 2024to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy);
- Be non-metastatic and have finished their primary treatment with a curative intent at least 3 months prior to study participation;
- Adjuvant hormonal therapy and immunotherapy form the exception to the rule are tolerated;
- Presence of self-reported persistent pain in the last 3 months that interferes with daily activities (yes/no)
Who cannot join
- Can not participate during the entire study period;
- Mentally or physically unable to participate in the study;
- Previous participation in a pain science education program.
- No acces to a digital device
- Do not speak/understand Dutch
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lore Dams, PhD contact
Belgium2 sites, 2 recruiting
- Recruiting
Universiteit Antwerpen
Antwerp
An De Groef, PhD, an.degroef@uantwerpen.be
Lore Dams, PhD, lore.dams@uantwerpen.be
- Recruiting
KU Leuven
Leuven
Nele Devoogdt, PhD, nele.devoogdt@kuleuven.be
An De Groef, PhD, an.degroef@kuleuven.be
About this study
The scientific goals of the project are:
- The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:
Read more
- usual care (i.e. superiority of the eHealth self-management support program) and
- a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) on pain-related disability (measured with the Pain Disability Index).
- The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:
- Other dimensions of pain
- Health-related quality of life
- Physical functioning, including physical activity levels
- Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence
- Participation in society, including return to work
- Healthcare-related costs for the patient and society
- The tertiary scientific objectives of this study are
- to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.
- To examine the implementation process, mechanisms of impact and contextual factors.
Read the detailed description
The current state-of-the art advocates for a biopsychosocial rehabilitation approach for persistent pain after breast cancer treatment. Within this approach pain science education is combined with promotion of an active lifestyle based on self-regulation techniques. The investigators argue for testing an innovative eHealth self-management support program for this purpose. The assumption is that this delivery mode reduces barriers to pain self-management support, by bringing timely support near to people, creating a safe environment as opposed to hospital settings, providing a multidimensional support model taking into account the biopsychosocial needs of patients, and lowering costs. This program can provide patients with the knowledge, proactive, cognitive and self-management skills to master their situation and journey towards less pain and pain-related disability and participation in normal life again. Therefore, the general aim of the proposed project is to investigate the effectiveness of an eHealth self-management support program for pain-related disability (I) in breast cancer survivors with persistent pain (P). The program makes use of an innovative chatbot format for delivering pain science education and motivating and monitoring physical activity. The eHealth program is automated using comprehensive decision-tree-based algorithms in order to promote pain self-management support. The primary scientific objective of the study is to determine the effectiveness of this eHealth self-management support program for persistent pain after breast cancer treatment compared to 1) usual care (i.e. superiority of the eHealth self-management support program) (C1) and 2) a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) (C2) on pain-related disability (O).
- Conditions
- Breast Cancer
- Being tested
- eHealth self-management support program, Face-to-face rehabilitation program
- Keywords
- eHealth, pain, active lifestyle, pain management, physiotherapy
- Medical subject headings
- Breast Neoplasms, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth self-management support programBehavioural
This web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle. The eHealth program will be accessible from any digital device (laptop, tablet, smartphone) after receiving a personal login code provided by the researcher. Participants go through the eHealth program independently at their own pace. It is recommended to do this in 8-12 weeks.
Face-to-face rehabilitation programBehavioural
The face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally and written. After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions. It is recommend to organise the in total 9 face-to-face sessions within a periode of 8-12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| eHealth self-management support program | Experimental | This web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle. Receives: Behavioral: eHealth self-management support program |
| Face-to-face rehabilitation program | Active comparator | The face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist (recruited and trained by the research team) to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally (explanation by the therapist) and written (information leaflet, summaries, pictures, metaphors and diagrams on computer and paper). After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions. Receives: Behavioral: Face-to-face rehabilitation program |
| Usual care group | No intervention | Usual care for breast cancer survivors with persistent pain consists of primarily a pharmacological approach and general advice to stay or become active. This information is given to the participant by means of a brochure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain-related disability
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain. The trial will be termed successful when superiority of the eHealth self-management to usual care and non-inferiority of the eHealth self-management program to face-to face rehabilitation program has been shown for the primary outcome at 6 months. Both tests will be based on the comparison of the mean value after correction for the baseline PDI (ANCOVA approach).
Measured: at 6 months follow-up
Secondary outcomes (24)
Pain related disability
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain
Measured: at 12 weeks and 12 months follow-up
Pain severity
Measured with a Visual Analogue Scale (0-100), a higher score indicates more severe pain.
Measured: at 12 weeks, 6 months and 12 months follow-up
Severity of neuropathic Pain
Measured with the Neuropathic Pain Symptom Inventory (0-100), a higher score indicates more severe pain.
Measured: at 12 weeks, 6 months and 12 months follow-up
Medication use
self-composed questionnaire
Measured: at 12 weeks, 6 months and 12 months follow-up
Pain location
Margolis Pain Diagram
Measured: at 12 weeks, 6 months and 12 months follow-up
Knowledge of neurophysiology of pain
measured with the Neurophysiology of Pain Test
Measured: at 6 weeks
Physical Activity pattern
measured with the Patterns of Activity Measure - Pain (short form). It measures 3 pain-related activity patterns: avoidance, overdoing, and pacing. Potential scores on each of the 3 POAM-P scales can range from 0 to 20. Higher scores in any pattern indicate more of the measured construct.
Measured: at 12 weeks, 6 months and 12 months follow-up
Physical functioning
measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Fatigue
measured with the Patient-Reported Outcomes Measurement Information System( PROMIS)-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Sleep disturbance
measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Pain Beliefs
Measured with the Survey of Pain Attitudes (SOPA)-short form. It contains seven subscales including 30 items in total with a 5-item Likert scale. Each domain of the SOPA is expressed as a score compared to the average of a group (T-score).
Measured: at 6 weeks, 12 weeks, 6 months and 12 months follow-up
Pain-related worrying
Measured with the Pain Catastrophizing Scale. Thirteen items are scored on a 5-item Likert scale ranging from "not" to "always". The total score ranges from 0 to 52, where higher scores are associated with higher levels of catastrophizing.
Measured: at 12 weeks, 6 months and 12 months follow-up
Vigilance and interpretation of physical sensations
Measured with the Bodily Threat Monitoring Scale. This is a new 19-item self-report measure that captures the tendency to monitor and interpret bodily sensations as symptomatic of something being wrong with one's body. Scores range from 0 to 76, with higher scores indicating greater bodily threat monitoring.
Measured: at 12 weeks, 6 months and 12 months follow-up
Depression
measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 Profile v2.01.Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Anxiety
measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Determinants for physical activity
measured with the Determinants of Physical Activity Questionnaire. Each item was assessed using a 7-point scale for all determinants of physical activity. Lower scores indicate low exercisers, while high scores indicate high exercisers.
Measured: at 12 weeks, 6 months and 12 months follow-up
Participation
measured with the PROMIS-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Well-being
measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. Each domain of the PROMIS is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Social Support
measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-57 Profile v2.01. Each domain of the PROMIS-57 is expressed as a score compared to the average of a group (T-score). A T-score is a standardized score. The average score in a population is assigned the value 50. The standard deviation becomes equated to 10 points.
Measured: at 12 weeks, 6 months and 12 months follow-up
Return to work rate
measured with a self-composed questionnaire
Measured: at 12 weeks, 6 months and 12 months follow-up
Medical costs of medical consumption
measured with the Medical Consumption Questionnaire. The costs of medical consumption are calculated by measuring the volumes of care multiplied by the cost price per unit of care.
Measured: at 12 weeks, 6 months and 12 months follow-up
Indirect costs related to disease outside health care
measured with the Productivity Cost Questionnaire. To calculate the costs of production losses, volumes are multiplied with unit costs.
Measured: at 12 weeks, 6 months and 12 months follow-up
Health-related quality of life
measured with the EuroQol-5Dimensions-5Levels (EQ-5D-5L) questionnaire. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Standard EQ-5D-5L value sets are available for different regions. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.
Measured: at 12 weeks, 6 months and 12 months follow-up
Patient Global Impression of Change
measured with the Patient Global Impression of Change (PGIC). PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: at 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start26 May 2024
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic randomized, multi-centric, three-arm controlled trial
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, University Ghent, KU Leuven, University Hospital, Antwerp
- Responsible party
- Principal investigator, An De Groef, Universiteit Antwerpen
- Investigators
- An De Groef, PhD, Principal investigator, Universiteit AntwerpenNele Devoogdt, PhD, Principal investigator, KU LeuvenGeert Crombez, PhD, Principal investigator, UGent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308029
- Sponsor's protocol ID
- Edge003203
- Other IDs
- T001122N, s68058
- Acronym
- PECAN
- Status last verified
- Jun 2025
- First submitted
- 6 Mar 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data are not openly available and are available from the principal investigator upon reasonable request.
Publications
De Groef A, Dams L, Moseley GL, Heathcote LC, Wiles LK, Catley M, Vogelzang A, Hibbert P, Morlion B, Van Overbeke M, Tack E, Van Dijck S, Devoogdt N, Gursen C, De Paepe AL, Mertens M, van Olmen J, Willem L, Tjalma W, Nevelsteen I, Neven P, Vanhoudt R, Wildemeersch D, De Backere F, Fieuws S, Crombez G, Meeus M. Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer survivors with persistent pain: the PECAN trial. BMJ Open. 2025 Aug 22;15(8):e099241. doi: 10.1136/bmjopen-2025-099241.
PubMed 40846340
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT06308029
- Acronym / sponsor ID
- PECAN / Edge003203
- Conditions
- Breast Cancer
- Keywords
- eHealth, pain, active lifestyle, pain management, physiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, University Ghent, KU Leuven, University Hospital, Antwerp
- Study start
- 26 May 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 13 Mar 2024 (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.
The scientific goals of the project are:
- The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:
- usual care (i.e. superiority of the eHealth self-management support program) and
- a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) on pain-related disability (measured with the Pain Disability Index).
- The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:
- Other dimensions of pain
- Health-related quality of life
- Physical functioning, including physical activity levels
- Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence
- Participation in society, including return to work
- Healthcare-related costs for the patient and society
- The tertiary scientific objectives of this study are
- to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.
- To examine the implementation process, mechanisms of impact and contextual factors.
Detailed description
The current state-of-the art advocates for a biopsychosocial rehabilitation approach for persistent pain after breast cancer treatment. Within this approach pain science education is combined with promotion of an active lifestyle based on self-regulation techniques. The investigators argue for testing an innovative eHealth self-management support program for this purpose. The assumption is that this delivery mode reduces barriers to pain self-management support, by bringing timely support near to people, creating a safe environment as opposed to hospital settings, providing a multidimensional support model taking into account the biopsychosocial needs of patients, and lowering costs. This program can provide patients with the knowledge, proactive, cognitive and self-management skills to master their situation and journey towards less pain and pain-related disability and participation in normal life again. Therefore, the general aim of the proposed project is to investigate the effectiveness of an eHealth self-management support program for pain-related disability (I) in breast cancer survivors with persistent pain (P). The program makes use of an innovative chatbot format for delivering pain science education and motivating and monitoring physical activity. The eHealth program is automated using comprehensive decision-tree-based algorithms in order to promote pain self-management support. The primary scientific objective of the study is to determine the effectiveness of this eHealth self-management support program for persistent pain after breast cancer treatment compared to 1) usual care (i.e. superiority of the eHealth self-management support program) (C1) and 2) a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) (C2) on pain-related disability (O).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pragmatic randomized, multi-centric, three-arm controlled trial
| Arm | Type | Receives |
|---|---|---|
| eHealth self-management support program | Experimental | Behavioral: eHealth self-management support programThis web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle. |
| Face-to-face rehabilitation program | Active comparator | Behavioral: Face-to-face rehabilitation programThe face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist (recruited and trained by the research team) to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally (explanation by the therapist) and written (information leaflet, summaries, pictures, metaphors and diagrams on computer and paper). After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions. |
| Usual care group | No intervention | –Usual care for breast cancer survivors with persistent pain consists of primarily a pharmacological approach and general advice to stay or become active. This information is given to the participant by means of a brochure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy);
- Be non-metastatic and have finished their primary treatment with a curative intent at least 3 months prior to study participation;
- Adjuvant hormonal therapy and immunotherapy form the exception to the rule are tolerated;
- Presence of self-reported persistent pain in the last 3 months that interferes with daily activities (yes/no)
Key exclusion criteria (5 listed)
- Can not participate during the entire study period;
- Mentally or physically unable to participate in the study;
- Previous participation in a pain science education program.
- No acces to a digital device
- Do not speak/understand Dutch
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 |
|---|---|---|
| eHealth self-management support programThis web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle. The eHealth program will be accessible from any digital device (laptop, tablet, smartphone) after receiving a personal login code provided by the researcher. Participants go through the eHealth program independently at their own pace. It is recommended to do this in 8-12 weeks. | Behavioural | eHealth self-management support program |
| Face-to-face rehabilitation programThe face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally and written. After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions. It is recommend to organise the in total 9 face-to-face sessions within a periode of 8-12 weeks. | Behavioural | Face-to-face rehabilitation program |
Primary outcome
Pain-related disability
Time frame: at 6 months follow-up
Measured with Pain Disability Index, an instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. Scores between 0 and 70. The higher the score the greater the person's disability due to pain. The trial will be termed successful when superiority of the eHealth self-management to usual care and non-inferiority of the eHealth self-management program to face-to face rehabilitation program has been shown for the primary outcome at 6 months. Both tests will be based on the comparison of the mean value after correction for the baseline PDI (ANCOVA approach).
24 secondary outcomes
Pain related disability
Time frame: at 12 weeks and 12 months follow-up
Pain severity
Time frame: at 12 weeks, 6 months and 12 months follow-up
Severity of neuropathic Pain
Time frame: at 12 weeks, 6 months and 12 months follow-up
Medication use
Time frame: at 12 weeks, 6 months and 12 months follow-up
Pain location
Time frame: at 12 weeks, 6 months and 12 months follow-up
Knowledge of neurophysiology of pain
Time frame: at 6 weeks
Physical Activity pattern
Time frame: at 12 weeks, 6 months and 12 months follow-up
Physical functioning
Time frame: at 12 weeks, 6 months and 12 months follow-up
Fatigue
Time frame: at 12 weeks, 6 months and 12 months follow-up
Sleep disturbance
Time frame: at 12 weeks, 6 months and 12 months follow-up
Pain Beliefs
Time frame: at 6 weeks, 12 weeks, 6 months and 12 months follow-up
Pain-related worrying
Time frame: at 12 weeks, 6 months and 12 months follow-up
Vigilance and interpretation of physical sensations
Time frame: at 12 weeks, 6 months and 12 months follow-up
Depression
Time frame: at 12 weeks, 6 months and 12 months follow-up
Anxiety
Time frame: at 12 weeks, 6 months and 12 months follow-up
Determinants for physical activity
Time frame: at 12 weeks, 6 months and 12 months follow-up
Participation
Time frame: at 12 weeks, 6 months and 12 months follow-up
Well-being
Time frame: at 12 weeks, 6 months and 12 months follow-up
Social Support
Time frame: at 12 weeks, 6 months and 12 months follow-up
Return to work rate
Time frame: at 12 weeks, 6 months and 12 months follow-up
Medical costs of medical consumption
Time frame: at 12 weeks, 6 months and 12 months follow-up
Indirect costs related to disease outside health care
Time frame: at 12 weeks, 6 months and 12 months follow-up
Health-related quality of life
Time frame: at 12 weeks, 6 months and 12 months follow-up
Patient Global Impression of Change
Time frame: at 12 weeks follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Derived from this study: PubMed 40846340De Groef A, Dams L, Moseley GL, Heathcote LC, Wiles LK, Catley M, Vogelzang A, Hibbert P, Morlion B, Van Overbeke M, Tack E, Van Dijck S, Devoogdt N, Gursen C, De Paepe AL, Mertens M, van Olmen J, Willem L, Tjalma W, Nevelsteen I, Neven P, Vanhoudt R, Wildemeersch D, De Backere F, Fieuws S, Crombez G, Meeus M. Study protocol for a pragmatic randomised controlled trial in Belgian primary care and hospital settings on the effectiveness of an eHealth self-management support programme consisting of pain education and coaching of activity needs in breast cancer survivors with persistent pain: the PECAN trial. BMJ Open. 2025 Aug 22;15(8):e099241. doi: 10.1136/bmjopen-2025-099241.
- Individual participant dataSharing planned: Yes. The data are not openly available and are available from the principal investigator upon reasonable request.
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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.
Lore Dams, PhD contact
An De Groef, PhD principal investigator
Universiteit Antwerpen
Nele Devoogdt, PhD principal investigator
KU Leuven
Geert Crombez, PhD principal investigator
UGent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth self-management support program and Face-to-face rehabilitation program in people with Breast Cancer, run by Universiteit Antwerpen 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact An De Groef, PhD (003216342171, an.degroef@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-related disability (time frame: at 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06308029, which also lists 1 linked publication.
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 26 Jun 2025.