Patients assigned to intervention group receive an 8-week EFT-program

Patients assigned to control group are placed on a waitlist for a period of 8 weeks

Emotional Freedom Techniques

Philip R Debruyne, MD, PhD, MSc, FRCP

The aim of this study is to further validate the CDT as a screening tool for identifying elderly cancer patients in need of a more in-depth cognitive evaluation within comprehensive geriatric assessment (CGA) and to validate the pre-defined cut-off score of ≤ 4 according to the Freund scoring system. All geriatric patients that are diagnosed with cancer will be screened by the oncology clinical nurse specialists attached to the respective multi-disciplinary clinics with the VES-13 and G8 questionnaire. Patients that screen positive, will be offered referral to the multi-disciplinary onco-geriatric program where a member of the research team will implement a full geriatric evaluation under supervision of the medical oncologist and/or geriatrician who will then formulate recommendations and might suggest referral to other health care providers. Individual results and survival data of all the patients that have given their informed consent will be registered in a database.

In this trial the investigators aim to establish whether Emotional Freedom Techniques (EFT) can reduce cognitive complaints in cancer survivors. All consenting patients aged 18 years or above, who have been diagnosed with a solid tumour of hematologic malignancy and who have completed or are in the late phase of a chemotherapy, radiotherapy, anti-hormonal or targeted therapy treatment, can participate in this trial. Patients should suffer from subjective cognitive complaints based on a score of 43 or more on the Cognitive Failure Questionnaire (CFQ). These patients will be randomly assigned to either the control or intervention group. Patients in the intervention group will be scheduled to receive an 8-week EFT intervention program. Other patients will be placed on an 8-week wait list after which patients will also start the EFT program.

Emotional Freedom Techniques to Reduce Patient Reported Cognitive Complaints in Cancer Survivors

A Randomized Wait-list Controlled Trial on the Use of Emotional Freedom Techniques as an Intervention Strategy to Reduce Patient Reported Cognitive Complaints in Cancer Survivors on Behalf of the Belgian Society for Medical Oncology (BSMO)-Cancer Survivorship Taskforce

Score of \<43 on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome

Reduction in score on FACIT Fatigue scale ; Minimum value: 0; Maximum value: 52; Higher scores mean worse outcome

Reduction in the score on the Distress Thermometer ; Minimum value: 0; Maximum value: 10; Higher scores mean worse outcome

Reduction in score on Beck Depression Inventory II ; Minimum value: 0; Maximum value: 63; Higher scores mean worse outcome

Improvement of the scores on the Global Health scale, functional scale and symptom scale ; Minimum value: 30; Maximum value: 126; Higher scores mean better outcome

Improvement on the score on the EQ-5D-3L; Minimum value: -0.285; Maximum value: 1; Higher scores mean better outcome

Number of cancer survivors presenting with cognitive complaints as measured by Cognitive Failure Questionnaire

Interaction effect of age and score on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome; cut-off at score of 43 on the Cognitive Failure Questionnaire

Interaction effect of gender and score on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome; cut-off at score of 43 on the Cognitive Failure Questionnaire

Interaction effect of distress and score on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome; cut-off at score of 43 on the Cognitive Failure Questionnaire

Interaction effect of fatigue and score on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome; cut-off at score of 43 on the Cognitive Failure Questionnaire

Interaction effect of cancer type and score on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome; cut-off at score of 43 on the Cognitive Failure Questionnaire

Interaction effect of cancer stage and score on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome; cut-off at score of 43 on the Cognitive Failure Questionnaire

Interaction effect of treatment and score on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome; cut-off at score of 43 on the Cognitive Failure Questionnaire

Universitair Ziekenhuis Brussel

AZ Klina

General Hospital Groeninge

Medical Oncologist

Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

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.

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.

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).

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.

Mindfulness Meditation

Philip R Debruyne, MD, PhD

Laura Tack, MSc, PhD

Christine Langenaeken, MD

Tom Boterberg, MD, PhD

Thaïs Baert, MD, PhD

Philip R. Debruyne, MD

Laura Tack, PhD

Kevin Punie, MD, PhD

Heidi Van den Bulck, MD

Jeroen Mebis, MD, PhD

Christel Fontaine, MD

Florence Van Ryckeghem, MD

Caroline Lamot, MD

Katherine Vandenborre, MD

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.

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:

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.

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

At the moment, there is no plan to make individual participant data (IPD) available to other researchers. Moreover, data will be pseudonimyzed.

• Effect of iEFT and iMMI on chronic biological stress measure as hair cortisol concentration

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.

Efficacy of iEFT and iMMI to reduce FCR (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.

Efficacy of iEFT and iMMI to reduce psychological distress (Distress Thermometer). Distress thermometer has a minimum value of 0 and maximum value of 10, with a higher score pointing out to a worse outcome.

Efficacy of iEFT and iMMI to reduce psychological distress (38-item Problem list). The Distress Thermometer includes 36 problems answered with "no" or "yes" clustered into five domains: practical problems, family problems, emotional problems, spiritual problems, and physical problems.

Efficacy of iEFT and iMMI to enhance Quality of Life (EORTC QOL Cancer Survivorship Core Questionnaire (QLQ-SURV100), amended with items from the EORTC Core QOL questionnaire QLQ-C30). EORTC QLQ-SURV 100 has a minimum value of 100 and maximum value of 406, with a higher score pointing out to a better outcome. EORTC QLQ-C30 has a minimum value of 30 and maximum value of 126, with a higher score pointing out to a better outcome.

Efficacy of iEFT and iMMI to enhance health status (EuroQol EQ-5D-5L). The visual analogue scale of the EuroQol EQ-5D-5L has a minimum value of 0 and maximum value of 100, with a higher score pointing out to a better outcome.

To identify the continuous application of iEFT or iMMI, participants will need to answer the questionnaire about whether they cotinue the application of EFT or mindfulness meditation, and the frequency of application, post-intervention period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Emotional Freedom Techniques to Reduce Patient Reported Cognitive Complaints in Cancer Survivors	NCT02771028	Subjective Cogn... Cancer	Emotional Freed...	18 Years -	General Hospital Groeninge
Targeting Fear of Cancer Recurrence in Cancer Survivors: Evaluation of Internet-Based Emotional Freedom Techniques and Internet-Based Mindfulness Meditation as Intervention Strategies	NCT06175208	Fear of Cancer ...	Emotional Freed... Mindfulness Med...	18 Years -	General Hospital Groeninge
Emotional Freedom Techniques to Reduce Patient Reported Cognitive Complaints in Cancer Survivors	NCT02771028	Subjective Cogn... Cancer	Emotional Freed...	18 Years -	General Hospital Groeninge

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