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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Subjective Cognitive Complaints
• Intervention / Treatment: Behavioral: Emotional Freedom Techniques

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brasschaat, Belgium, 2930
    • General Hospital Klina Brasschaat
  • Brussels, Belgium, 1090
    • Brussels University Hospital
  • Kortrijk, Belgium, 8500
    • General Hospital Groeninge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients should have reached a minimum age of 18 years at the time of enrolment
• Histologically confirmed diagnosis of a solid cancer or hematologic malignancy
• Patients should have received chemo- or radiotherapy, targeted therapy of hormonal treatment before enrollment (active treatment with anti-hormonal therapy or brachytherapy is allowed)
• Patients can be included in the latest phase of their chemotherapy, radiotherapy, anti-hormonal or targeted therapy treatment
• Patients should have been treated with curative intent or have an expected life expectancy of at least 5 years
• Patients must suffer from subjective cognitive complaints based on the Cognitive Failure Questionnaire (cut-off ≥ 43)
• Patients should be able to adequately communicate in Dutch or French
• Patients should present with a sufficient mental and physical functional status (according to investigator's judgment)

Exclusion Criteria:

• Patients who received a treatment with palliative intent
• Patients showing signs of mental deterioration
• Patients suffering from an organic brain syndrome
• Patients who are alcohol or drug dependent
• Patients with a major psychiatric or neurologic disorder that could potentially invalidate assessment; a prior or current diagnosis of a depressive, anxiety or adjustment disorder is allowed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Patients assigned to intervention group receive an 8-week EFT-program	Behavioral: Emotional Freedom Techniques
No Intervention: Control group; Patients assigned to control group are placed on a waitlist for a period of 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cognitive complaints measured by Cognitive Failure Questionnaire	Score of <43 on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome	Week 8, 16, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale	Reduction in score on FACIT Fatigue scale ; Minimum value: 0; Maximum value: 52; Higher scores mean worse outcome	Week 8, 16, 24
Change in psychological distress measured by Distress Thermometer	Reduction in the score on the Distress Thermometer ; Minimum value: 0; Maximum value: 10; Higher scores mean worse outcome	Week 8, 16, 24
Change in depressive symptoms measured by Beck Depression Inventory II	Reduction in score on Beck Depression Inventory II ; Minimum value: 0; Maximum value: 63; Higher scores mean worse outcome	Week 8, 16, 24
Change in quality of life measured by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30	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	Week 8, 16, 24
Chang in quality of life measured by EQ-5D-3L	Improvement on the score on the EQ-5D-3L; Minimum value: -0.285; Maximum value: 1; Higher scores mean better outcome	Week 8, 16, 24
Change in long-term quality of life measured by the EuroQol EQ-5D-3L	Improvement on the score on the EQ-5D-3L; Minimum value: -0.285; Maximum value: 1; Higher scores mean better outcome	6 months and 12 months
Number of cancer survivors presenting with cognitive complaints as measured by Cognitive Failure Questionnaire	Number of cancer survivors presenting with cognitive complaints as measured by Cognitive Failure Questionnaire	Week 8, 16, 24
Influence of age on cognitive complaints in cancer survivors	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	Week 8, 16, 24
Influence of gender on cognitive complaints in cancer survivors	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	Week 8, 16, 24
Influence of distress on cognitive complaints in cancer survivors as measured by Distress Thermometer	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	Week 8, 16, 24
Influence of fatigue (FACIT-Fatigue Scale) on cognitive complaints in cancer survivors	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	Week 8, 16, 24
Influence of cancer type on cognitive complaints in cancer survivors	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	Week 8, 16, 24
Influence of cancer stage on cognitive complaints in cancer survivors	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	Week 8, 16, 24
Influence of the received treatment on cognitive complaints in cancer survivors	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	Week 8, 16, 24

Collaborators and Investigators

• Sponsor: General Hospital Groeninge
• Collaborators: Universitair Ziekenhuis Brussel; AZ Klina
• Investigators: Principal Investigator: Philip R Debruyne, MD, PhD, MSc, FRCP, AZ Groeninge

Publications and helpful links

General Publications

• Tack L, Lefebvre T, Lycke M, Langenaeken C, Fontaine C, Borms M, Hanssens M, Knops C, Meryck K, Boterberg T, Pottel H, Schofield P, Debruyne PR. A randomised wait-list controlled trial to evaluate Emotional Freedom Techniques for self-reported cancer-related cognitive impairment in cancer survivors (EMOTICON). EClinicalMedicine. 2021 Aug 19;39:101081. doi: 10.1016/j.eclinm.2021.101081. eCollection 2021 Sep.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: April 21, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AZGS2016034