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Subjective Cognitive ComplaintsEMOTICONNCT02771028

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

A study testing Emotional Freedom Techniques in people with Subjective Cognitive Complaints and Cancer, run by General Hospital Groeninge at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Subjective Cognitive Complaints, Cancer
What is being tested?
Emotional Freedom Techniques
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
3 sitesBelgium
Study dates
1 Oct 2016to 15 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • General Hospital Klina Brasschaat

    Brasschaat, 2930

  • Brussels University Hospital

    Brussels, 1090

  • General Hospital Groeninge

    Kortrijk, 8500

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Emotional Freedom Techniques
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emotional Freedom TechniquesBehavioural

Study groups in NCT02771028
Study groupRoleWhat they receive
Intervention groupExperimentalPatients assigned to intervention group receive an 8-week EFT-program
Receives: Behavioral: Emotional Freedom Techniques
Control groupNo interventionPatients assigned to control group are placed on a waitlist for a period of 8 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 8, 16, 24

Secondary outcomes (14)

  1. 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

    Measured: Week 8, 16, 24

  2. 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

    Measured: Week 8, 16, 24

  3. 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

    Measured: Week 8, 16, 24

  4. 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

    Measured: Week 8, 16, 24

  5. 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

    Measured: Week 8, 16, 24

  6. 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

    Measured: 6 months and 12 months

  7. 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

    Measured: Week 8, 16, 24

  8. 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

    Measured: Week 8, 16, 24

  9. 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

    Measured: Week 8, 16, 24

  10. 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

    Measured: Week 8, 16, 24

  11. 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

    Measured: Week 8, 16, 24

  12. 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

    Measured: Week 8, 16, 24

  13. 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

    Measured: Week 8, 16, 24

  14. 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

    Measured: Week 8, 16, 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2016 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion15 Mar 2020
  4. Study completion15 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771028
Sponsor's protocol ID
AZGS2016034
Acronym
EMOTICON
Status last verified
Sep 2022
First submitted
21 Apr 2016
Last updated
9 Sep 2022
Results posted
No

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.

    PubMed 34466793

Questions about this trial

What is this clinical trial studying?

A study testing Emotional Freedom Techniques in people with Subjective Cognitive Complaints and Cancer, run by General Hospital Groeninge at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive complaints measured by Cognitive Failure Questionnaire (time frame: Week 8, 16, 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02771028, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.

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