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

NCT06175208 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 339

Last updated 2024-07-26

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kom Op Tegen Kanker

    collaborator OTHER
  • az Glorieux

    collaborator UNKNOWN
  • AZ Klina

    collaborator OTHER
  • AZ Vesalius

    collaborator OTHER
  • Imeldaziekenhuis

    collaborator OTHER
  • Jessa Hospital

    collaborator OTHER
  • University Hospital, Antwerp

    collaborator OTHER
  • Universitair Ziekenhuis Brussel

    collaborator OTHER
  • University Hospital, Ghent

    collaborator OTHER
  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER
  • Vitaz

    collaborator OTHER
  • General Hospital Groeninge

    lead OTHER

Principal Investigators

  • Philip R Debruyne, MD, PhD · Kortrijk Cancer Centre,General Hospital Groeninge

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2028-08-01
Completion
2028-10-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06175208 on ClinicalTrials.gov