NCT06175208

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 339 (estimated)
• Sponsor: General Hospital Groeninge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-03
• Primary completion: 2028-08-01
• Completion: 2028-10-30
• First posted: 2023-12-18
• Last updated: 2024-07-26

Locations

11 sites across 1 country: Belgium