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ENROLLING BY INVITATION
NCT06175208
NA

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

Sponsor: General Hospital Groeninge

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

339

Start Date

2024-07-03

Completion Date

2028-10-30

Last Updated

2024-07-26

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

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.

Locations (11)

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