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

NCT ID: NCT06175208

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2028-10-30

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 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.

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:

Conditions

Fear of Cancer Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

internet-based Emotional Freedom Techniques (iEFT)

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.

Group Type: EXPERIMENTAL

Emotional Freedom Techniques

Intervention Type: BEHAVIORAL

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.

internet-based mindfulness meditation intervention (iMMI)

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.

Group Type: ACTIVE_COMPARATOR

Mindfulness Meditation

Intervention Type: BEHAVIORAL

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.

Wait-list Control Group (WLC)

The 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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Emotional Freedom Techniques

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.

Intervention Type: BEHAVIORAL

Mindfulness Meditation

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

iEFT; iMMI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

az Glorieux

UNKNOWN

Sponsor Role: collaborator

AZ Klina

OTHER

Sponsor Role: collaborator

AZ Vesalius

OTHER

Sponsor Role: collaborator

Imeldaziekenhuis

OTHER

Sponsor Role: collaborator

Jessa Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Vitaz

OTHER

Sponsor Role: collaborator

General Hospital Groeninge

OTHER

Sponsor Role: lead

Responsible Party

Dr. Philip Debruyne

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip R Debruyne, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kortrijk Cancer Centre,General Hospital Groeninge

Locations

AZ Klina

Brasschaat, Antwerp, Belgium

University Hospital Antwerp

Edegem, Antwerp, Belgium

University Hospital Gent

Ghent, East-Flanders, Belgium

University Hospital Leuven

Leuven, Vlaams-Brabant, Belgium

Kortrijk Cancer Centre, az groeninge

Kortrijk, West-Flanders, Belgium

Imelda ziekenhuis

Bonheiden, , Belgium

Jessa ziekenhuis

Hasselt, , Belgium

University Hospital Brussels

Jette, , Belgium

AZ Glorieux

Ronse, , Belgium

VITAZ

Sint-Niklaas, , Belgium

AZ Vesalius

Tongeren, , Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 34466793 (View on PubMed)

Other Identifiers

23435_ REMOTE

Identifier Type: -

Identifier Source: org_study_id