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NCT Number: NCT02771028

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

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.

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Key information

Conditions

Subjective Cognitive Complaints Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital Klina Brasschaat, Brasschaat, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotional Freedom Techniques

Behavioral

Primary outcomes

  1. Change in cognitive complaints measured by Cognitive Failure Questionnaire

    Time frame: Week 8, 16, 24

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

Secondary outcomes

  1. Change in fatigue measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale

    Time frame: Week 8, 16, 24

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

  2. Change in psychological distress measured by Distress Thermometer

    Time frame: Week 8, 16, 24

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

  3. Change in depressive symptoms measured by Beck Depression Inventory II

    Time frame: Week 8, 16, 24

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

  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

    Time frame: Week 8, 16, 24

    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

  5. Chang in quality of life measured by EQ-5D-3L

    Time frame: Week 8, 16, 24

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

  6. Change in long-term quality of life measured by the EuroQol EQ-5D-3L

    Time frame: 6 months and 12 months

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

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

    Time frame: Week 8, 16, 24

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

  8. Influence of age on cognitive complaints in cancer survivors

    Time frame: Week 8, 16, 24

    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

  9. Influence of gender on cognitive complaints in cancer survivors

    Time frame: Week 8, 16, 24

    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

  10. Influence of distress on cognitive complaints in cancer survivors as measured by Distress Thermometer

    Time frame: Week 8, 16, 24

    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

  11. Influence of fatigue (FACIT-Fatigue Scale) on cognitive complaints in cancer survivors

    Time frame: Week 8, 16, 24

    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

  12. Influence of cancer type on cognitive complaints in cancer survivors

    Time frame: Week 8, 16, 24

    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

  13. Influence of cancer stage on cognitive complaints in cancer survivors

    Time frame: Week 8, 16, 24

    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

  14. Influence of the received treatment on cognitive complaints in cancer survivors

    Time frame: Week 8, 16, 24

    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

Sponsors and collaborators

Lead sponsor

General Hospital Groeninge

Other

Collaborators

  • AZ Klina
  • Universitair Ziekenhuis Brussel

Registry information

Official study 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

Acronym: EMOTICON

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
May 12, 2016
Registry last updated
Sep 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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