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
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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