Status:
ENROLLING_BY_INVITATION
Targeting Fear of Cancer Recurrence in Cancer Survivors: Evaluation of Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies
Lead Sponsor:
General Hospital Groeninge
Collaborating Sponsors:
Kom Op Tegen Kanker
az Glorieux
Conditions:
Fear of Cancer Recurrence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this trial, the investigators introduce two internet-based psychological methods to meet the currently unmet medical need to cope with Fear of Cancer Recurrence (FCR) beyond the acute phase of canc...
Detailed Description
Despite our adequate medical care and financial support systems, the mental wellbeing and quality of life after cancer diagnosis and treatment is often poorly addressed in clinical settings. Previous ...
Eligibility Criteria
Inclusion
- Patients should have reached a minimum age of 18 years at the time of enrolment
- Patients should have a histologically confirmed diagnosis of a solid cancer or haematologic malignancy
- Patients should have completed surgery, chemotherapy, radiation therapy, immunotherapy, hormone therapy, targeted drug therapy or a combination of these at least 2 months ago and no longer than 5 years ago at the time of enrolment
- Patients should have an expected life expectancy of at least 5 years
- Patients are disease-free at the time of enrolment, as defined by the absence of somatic disease activity parameters
- Patients can be included in a stable phase of their immunotherapy (e.g. adjuvant use of checkpoint inhibitors for melanoma), hormonal therapy (e.g. for breast and prostate cancer), targeted drug therapy (e.g. trastuzumab and pertuzumab for breast cancer; stable dose of PARP inhibitors for ovarian cancer; retuximab for lymphoma), or a combination of these
- Patients must suffer from high FCR based on the Cancer Worry Scale (cut-off ≥ 14)
- Patients should be able to adequately communicate in Dutch
- Patients should present with a sufficient mental and physical functional status (according to investigator's judgment and first baseline assessment) for completing the questionnaires and neuropsychological assessment
- Patients under current treatment for a depression or anxiety disorder are allowed to enrol provided their depression or anxiety disorder is stable
Exclusion
- Patients who received a treatment with palliative intent
- Patients showing signs of mental deterioration
- Patients suffering from organic brain syndrome (concussion without neurological symptoms and negative imaging is allowed)
- Patients who are alcohol or drug dependent
- Patients with another serious or chronic medical, neurologic or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in either of the intervention programmes or from the measurement of intervention outcomes; a prior diagnosis of a depressive, anxiety or adjustment disorder is allowed
- Patients who cannot commit to the intervention schedule; obstacles such as surgery or long-term hospitalisation, change of residence or work, … can have an emotional and practical impact which makes these patients not eligible for participation.
- Patients who actively practice EFT or mindfulness(based) meditation
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT06175208
Start Date
July 3 2024
End Date
October 30 2028
Last Update
July 26 2024
Active Locations (11)
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1
AZ Klina
Brasschaat, Antwerp, Belgium, 2930
2
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
3
University Hospital Gent
Ghent, East-Flanders, Belgium, 9000
4
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000