Status:
ACTIVE_NOT_RECRUITING
PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborating Sponsors:
Vrije Universiteit Brussel
Kom Op Tegen Kanker
Conditions:
Breast Neoplasms
Survivorship
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Breast cancer is the most frequently diagnosed cancer in women worldwide. An important portion of the breast cancer survivors will face chronic pain complaints. These pain complaints do not only impac...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- In order to be eligible, participants have to fulfil the definition for survivorship introduced by the European Organisation of Research and Treatment of Cancer (EORTC) Survivorship Task Force, in which a cancer survivor is: 'any person who has been diagnosed with cancer, has completed his or her primary treatment (with the exception of maintenance therapy) and has no evidence of active disease'. Therefore, participants need to:
- Be women aged 18 years or older.
- Be in complete remission and should have finished their primary treatment with a curative intent at least 3 months prior to study participation. Adjuvant hormonal therapy and immunotherapy are tolerated.
- Report a pain severity of at least 3/10 on the Brief Pain Inventory.
- Be able to speak and read Dutch in order to give informed consent and to complete the assessment tools.
- Show evidence of perceived injustice, defined as a score of 17 or higher on the Injustice Experience Questionnaire (IEQ).
- Exclusion Criteria
- Participants will be excluded if they:
- Are diagnosed with new neoplasms or metastases.
- Have not reached the stable level of a chronic disease and/or which is causing pain complaints (e.g. fibromyalgia, rheumatoid arthritis…).
- Are suffering from severe psychological or psychiatric diseases.
- Are suffering from dementia or cognitive impairment (unable to understand the test instructions and/or a result of ≤11, corresponding with MMSE ≤23, on the Six-item Cognitive Impairment Test (6-item CIT) is a short questionnaire containing 6 items.
- Recently started a new therapy which has not yet resulted in a stable level and might interference with one of the treatments.
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04730154
Start Date
April 1 2021
End Date
December 1 2025
Last Update
April 2 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
AZ Rivierenland
Bornem, Antwerpen, Belgium, 2880
2
Vrije Universiteit Brussel
Jette, Brussels Capital, Belgium, 1090
3
Universiteit Hasselt - campus Diepenbeek
Diepenbeek, Limburg, Belgium, 3590
4
Imeldaziekenhuis
Bonheiden, Vlaams-Brabant, Belgium, 2820