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Fear of Cancer RecurrenceREMOTENCT06175208

Targeting Fear of Cancer Recurrence in Cancer Survivors: Evaluation of Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies

A study testing Emotional Freedom Techniques and Mindfulness Meditation in people with Fear of Cancer Recurrence, run by General Hospital Groeninge at 11 sites in Belgium.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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 cancer treatment: internet-based emotional freedom techniques (iEFT) and internet-based mindfulness intervention (iMMI). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fear of Cancer Recurrence
What is being tested?
Emotional Freedom Techniques and Mindfulness Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
339 participants
Where
11 sitesBelgium
Study dates
3 Jul 2024to 30 Oct 2028
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 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

Belgium11 sites

  • Imelda ziekenhuis

    Bonheiden, 2820

  • AZ Klina

    Brasschaat, Antwerp, 2930

  • University Hospital Antwerp

    Edegem, Antwerp, 2650

  • University Hospital Gent

    Ghent, East-Flanders, 9000

  • Jessa ziekenhuis

    Hasselt, 3500

  • University Hospital Brussels

    Jette, 1090

  • Kortrijk Cancer Centre, az groeninge

    Kortrijk, West-Flanders, 8500

  • University Hospital Leuven

    Leuven, Vlaams-Brabant, 3000

  • AZ Glorieux

    Ronse, 9600

  • VITAZ

    Sint-Niklaas, 9100

  • AZ Vesalius

    Tongeren, 3700

Other trials in Belgium

About this study

Official title: 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

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.

Read the 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 research showed that Fear of Cancer Recurrence (FCR) is one of the most common psychological burdens faced by 39%-97% of cancer survivors. In this phase III randomized multicentre trial, patients will be allocated to either the iEFT group, iMMI group or wait-list control (WLC) group for a study trajectory of 6 weeks. 339 cancer survivors, between 6 months and 5 years since diagnosis, and who have completed their primary cancer treatment (i.e. surgery, radiation, and/or chemotherapy) will be enrolled and randomized 1:1:1 to one of the two intervention groups or the WLC group. Participants will complete evaluation questionnaires at baseline (T0), after 6 weeks (T1) and 12 weeks (T2) of intervention or waiting list, and 24 weeks (T3). A biomarker endpoint includes the measurement of chronic biologic stress in hair cortisol concentration. Therefore, optional hair collection may take place before (T0) and after the 6-week intervention (T1). Primary objective is to evaluate the feasibility and efficacy of iEFT and iMMI as an intervention strategy to reduce FCR in cancer survivors. The investigators hypothesize that an intervention with iEFT or iMMI will be superior compared to the WLC group at T1. Secondary objectives include the following:

Being tested
Emotional Freedom Techniques, Mindfulness Meditation
Keywords
Fear of Cancer Recurrence, Emotional Freedom Techniques, Mindfulness Meditation, Cancer survivors, Psychosocial cancer-related symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Freedom TechniquesBehavioural

    Also called iEFT

    Every participant may be randomized to either the iEFT, iMMI, or WLC group. All patients will be randomised to one of the three groups and be involved in a 6-week trajectory.

  • Mindfulness MeditationBehavioural

    Also called iMMI

    Every participant may be randomized to either the iEFT, iMMI, or WLC group. All patients will be randomised to one of the three groups and be involved in a 6-week trajectory.

Study groups in NCT06175208
Study groupRoleWhat they receive
internet-based Emotional Freedom Techniques (iEFT)ExperimentalThe 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.
Receives: Behavioral: Emotional Freedom Techniques
internet-based mindfulness meditation intervention (iMMI)Active comparatorThe 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.
Receives: Behavioral: Mindfulness Meditation
Wait-list Control Group (WLC)No interventionThe third arm of the study refers to the wait-list control (WLC) group with delayed intervention offered to the participants after they have completed parallel outcome assessments alongside the participants receiving the two interventions iEFT and iMMI, but not until the end of data collection (i.e. 6 weeks after the post-intervention assessment T1 for the cohort). Patients included in the WLC group can optionally join either the iEFT or iMMI group according to their preference, after 12 weeks (T2).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fear of Cancer Recurrence

    The primary endpoint will be reached after the first period of performing iEFT or iMMI during 6 weeks or be at the waiting list for 6 weeks (T1) where we will look at the efficacy of iEFT and iMMI to alleviate of Fear of Cancer Recurrence (FCR) based on the Fear of Cancer Recurrence Inventory (FCRI). FCRI has a minimum value of 0 and maximum value of 168, with a higher score pointing out to a worse outcome.

    Measured: 6 weeks (T1)

Secondary outcomes (6)

  1. Follow-up of Fear of Cancer Recurrence

    Efficacy of iEFT and iMMI to reduce FCR (Fear of Cancer Recurrence Inventory; FCRI). FCRI has a minimum value of 0 and maximum value of 168, with a higher score pointing out to a worse outcome.

    Measured: T0 (baseline), T1 (6 weeks), T2 (12 weeks) and T3 (24 weeks)

  2. Psychological Distresss

    Efficacy of iEFT and iMMI to reduce psychological distress (Distress Thermometer). Distress thermometer has a minimum value of 0 and maximum value of 10, with a higher score pointing out to a worse outcome.

    Measured: T0 (baseline), T1 (6 weeks), T2 (12 weeks) and T3 (24 weeks)

  3. Psychological Distresss

    Efficacy of iEFT and iMMI to reduce psychological distress (38-item Problem list). The Distress Thermometer includes 36 problems answered with "no" or "yes" clustered into five domains: practical problems, family problems, emotional problems, spiritual problems, and physical problems.

    Measured: T0 (baseline), T1 (6 weeks), T2 (12 weeks) and T3 (24 weeks)

  4. Fear of Cancer Recurrence

    Efficacy of iEFT and iMMI to enhance Quality of Life (EORTC QOL Cancer Survivorship Core Questionnaire (QLQ-SURV100), amended with items from the EORTC Core QOL questionnaire QLQ-C30). EORTC QLQ-SURV 100 has a minimum value of 100 and maximum value of 406, with a higher score pointing out to a better outcome. EORTC QLQ-C30 has a minimum value of 30 and maximum value of 126, with a higher score pointing out to a better outcome.

    Measured: T0 (baseline), T1 (6 weeks), T2 (12 weeks) and T3 (24 weeks)

  5. Fear of Cancer Recurrence

    Efficacy of iEFT and iMMI to enhance health status (EuroQol EQ-5D-5L). The visual analogue scale of the EuroQol EQ-5D-5L has a minimum value of 0 and maximum value of 100, with a higher score pointing out to a better outcome.

    Measured: T0 (baseline), T1 (6 weeks), T2 (12 weeks) and T3 (24 weeks)

  6. Number of participants continuing the intervention after T1

    To identify the continuous application of iEFT or iMMI, participants will need to answer the questionnaire about whether they cotinue the application of EFT or mindfulness meditation, and the frequency of application, post-intervention period.

    Measured: T2 (12 weeks) and T3 (24 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2023
  2. Study start3 Jul 2024
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multi-site, randomized, three arm trial that will evaluate the efficacy of two distinct types of group interventions to target fear of cancer recurrence (FCR) in cancer survivors. The first intervention entails emotional freedom techniques (EFT). The other intervention is mindfulness meditation. The third group is the wait-list control group.
Masking
None (open label)
Enrolment
339 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06175208
Sponsor's protocol ID
23435_ REMOTE
Acronym
REMOTE
Status last verified
Jul 2024
First submitted
21 Nov 2023
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At the moment, there is no plan to make individual participant data (IPD) available to other researchers. Moreover, data will be pseudonimyzed.

Publications

  • Tack 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.

    PubMed 34466793

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Freedom Techniques and Mindfulness Meditation in people with Fear of Cancer Recurrence, run by General Hospital Groeninge at 11 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 10 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear of Cancer Recurrence (time frame: 6 weeks (T1)). 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 NCT06175208, 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 Jul 2024.

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