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

Cancer Clinical Trial

— EMOTICON  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771028
• Other study ID #: AZGS2016034
• Status: Completed
• Phase: N/A
• Start date: October 1, 2016
• Est. completion date: March 15, 2021

Study information

• Verified date: September 2022
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Subjective Cognitive Complaints

Intervention

Behavioral:
• Emotional Freedom Techniques

Locations

Country	Name	City	State
Belgium	General Hospital Klina Brasschaat	Brasschaat
Belgium	Brussels University Hospital	Brussels
Belgium	General Hospital Groeninge	Kortrijk

Sponsors (3)

Lead Sponsor	Collaborator
General Hospital Groeninge	AZ Klina, Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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