Clinical trial · Interventional
Targeting Fear of Cancer Recurrence in Cancer Survivors: Evaluation of Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies
Targeting Fear of Cancer Recurrence in Cancer Survivors: a Multicentre Randomized Controlled Trial to Evaluate Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 cancer treatment: internet-based emotional freedom techniques (iEFT) and internet-based mindfulness intervention (iMMI). The primary aim of this trial is to examine the efficacy of Internet-Based Emotional Freedom Techniques (iEFT) and Internet-Based Mindfulness Meditation Intervention (iMMI) to alleviate Fear of Cancer Recurrence (FCR) in cancer survivors, as determined through the Fear of Cancer Recurrence Inventory (FCRI) in cancer survivors. To translate a statistically significant effect on FCR into a clinically significant change, the investigators would need to detect a between-group difference in mean FCRI at T1 of 10 points using an independent samples t-test (two experimental groups are compared against a single wait-list control). When the application of iEFT and/or iMMI appears effective to reduce FCR, these self-help methods could be implemented in clinical settings. The use of these low cost interventions with a low threshold, by an internet-based approach, will facilitate a potential implementation in clinical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fear of Cancer Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Emotional Freedom Techniques | Behavioral | — | UNRESOLVED |
| Mindfulness Meditation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- internet-based Emotional Freedom Techniques (iEFT)
- description
- The first intervention entails emotional freedom techniques (EFT). EFT is a brief and easy to learn exposure therapy, originally developed to manage phobias and nowadays known to have many positive effects on both physiological and psychological aspects. Participants will apply EFT daily for the period of 6 weeks. During the trajectory, there is a first information session for participants (±20 minutes) and two follow-up sessions (±15 minutes). These sessions will be guided by the iEFT practitioner. This is an oncology health professional who has gone through a specific EFT training acknowledged by EFT International and is thus qualified and trained to conduct the trial.
- interventionNames
- Behavioral: Emotional Freedom Techniques
- type
- ACTIVE_COMPARATOR
- label
- internet-based mindfulness meditation intervention (iMMI)
- description
- The second intervention is a mindfulness meditation-based intervention focused on improving psychological, behavioural, and biological function in cancer survivors based on following sources: Mindfulness trainingsboek, Het achtweekse programma, stap voor stap (1), Mindfulness bij stress, burn-out en depressie, Een 8-weken-stappenplan voor hulpverleners (2), Mindfulness-based cognitive therapy for depression (3), Met radicale compassie naar de wereld kijken, De RAIN-methode (4). The mindfulness group intervention programme will be conducted once a week, for 2 hours during 6 weeks, by a trained mindfulness provider who will follow the study intervention protocol. Participants will apply mindfulness meditation daily for the period of 6 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- RESULTTack L, Lefebvre T, Lycke M, Langenaeken C, Fontaine C, Borms M, Hanssens M, Knops C, Meryck K, Boterberg T, Pottel H, Schofield P, Debruyne PR. A randomised wait-list controlled trial to evaluate Emotional Freedom Techniques for self-reported cancer-related cognitive impairment in cancer survivors (EMOTICON). EClinicalMedicine. 2021 Aug 19;39:101081. doi: 10.1016/j.eclinm.2021.101081. eCollection 2021 Sep. PMID 34466793