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

NCT06175208 | Enrolling By Invitation

• 1 other identifier: 23435_ REMOTE
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 11

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.

Conditions

Fear of Cancer Recurrence

Keywords

Fear of Cancer Recurrence; Emotional Freedom Techniques; Mindfulness Meditation; Cancer survivors; Psychosocial cancer-related symptoms

Outcome Measures

Primary Outcomes (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.

  6 weeks (T1)

Secondary Outcomes (6)

• Follow-up of Fear of Cancer Recurrence

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

• Psychological Distresss

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

• Psychological Distresss

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

• Fear of Cancer Recurrence

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

• Fear of Cancer Recurrence

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

Other Outcomes (1)

• Biomarker endpoint

  T0 (baseline), T1 (6 weeks), but this endpoint will be completed only when the primary objective would be positive at T1

Study Arms (3)

internet-based Emotional Freedom Techniques (iEFT)

EXPERIMENTAL

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.

Behavioral: Emotional Freedom Techniques

internet-based mindfulness meditation intervention (iMMI)

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness Meditation

Wait-list Control Group (WLC)

NO INTERVENTION

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).

Interventions

Emotional Freedom Techniques 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.

Also known as: iEFT

internet-based Emotional Freedom Techniques (iEFT)

Mindfulness Meditation 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.

Also known as: iMMI

internet-based mindfulness meditation intervention (iMMI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Groeninge: lead
• Kom Op Tegen Kanker: collaborator
• az Glorieux: collaborator
• AZ Klina: collaborator
• AZ Vesalius: collaborator
• Imeldaziekenhuis: collaborator
• Jessa Hospital: collaborator
• University Hospital, Antwerp: collaborator
• Universitair Ziekenhuis Brussel: collaborator
• University Hospital, Ghent: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• Vitaz: collaborator

Study Sites (11)

AZ Klina

Brasschaat, Antwerp, 2930, Belgium

Location

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

University Hospital Gent

Ghent, East-Flanders, 9000, Belgium

Location

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Kortrijk Cancer Centre, az groeninge

Kortrijk, West-Flanders, 8500, Belgium

Location

Imelda ziekenhuis

Bonheiden, 2820, Belgium

Location

Jessa ziekenhuis

Hasselt, 3500, Belgium

Location

University Hospital Brussels

Jette, 1090, Belgium

Location

AZ Glorieux

Ronse, 9600, Belgium

Location

VITAZ

Sint-Niklaas, 9100, Belgium

Location

AZ Vesalius

Tongeren, 3700, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34466793 RESULT

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Philip R Debruyne, MD, PhD

  Kortrijk Cancer Centre,General Hospital Groeninge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 18, 2023
• Study Start: July 3, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (11)