Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment

NCT06308029 | Recruiting DMC

• 3 other identifiers: Edge003203T001122Ns68058
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

The scientific goals of the project are:

• 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.

Conditions

Breast Cancer

Keywords

eHealth; pain; active lifestyle; pain management; physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  at 6 months follow-up

Secondary Outcomes (24)

• Pain related disability

  at 12 weeks and 12 months follow-up

• Pain severity

  at 12 weeks, 6 months and 12 months follow-up

• Severity of neuropathic Pain

  at 12 weeks, 6 months and 12 months follow-up

• Medication use

  at 12 weeks, 6 months and 12 months follow-up

• Pain location

  at 12 weeks, 6 months and 12 months follow-up

Study Arms (3)

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.

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.

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.

Interventions

eHealth self-management support program BEHAVIORAL

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.

eHealth self-management support program

Face-to-face rehabilitation program BEHAVIORAL

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.

Face-to-face rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• University Ghent: collaborator
• KU Leuven: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (2)

Universiteit Antwerpen

Antwerp, Belgium

RECRUITING

KU Leuven

Leuven, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 40846340 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pain; Agnosia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• An De Groef, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• Nele Devoogdt, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Geert Crombez, PhD

  UGent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

An De Groef, PhD

CONTACT

003216342171; an.degroef@uantwerpen.be

Lore Dams, PhD

CONTACT

lore.dams@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pragmatic randomized, multi-centric, three-arm controlled trial

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: May 26, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: on request
• Access Criteria: on request

Locations

BE (2)