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Emotional Freedom Techniques as an Intervention Strategy to Reduce Patient Reported Cognitive Complaints in Cancer Survivors (EMOTICON)

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ClinicalTrials.gov Identifier: NCT02771028
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
Universitair Ziekenhuis Brussel
AZ Klina
Information provided by (Responsible Party):
Dr. Philip Debruyne, General Hospital Groeninge

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Subjective Cognitive Complaints Cancer Behavioral: Emotional Freedom Techniques Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Reduction of cognitive complaints measured by Cognitive Failure Questionnaire [ Time Frame: Week 8, 16, 24 ]

Secondary Outcome Measures :
  1. Reduction in psychological distress measured by Distress Thermometer [ Time Frame: Week 8, 16, 24 ]
  2. Reduction in fatigue measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale [ Time Frame: Week 8, 16, 24 ]
  3. Influence on 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 ]
  4. Influence on quality of life measured by EQ-5D [ Time Frame: Week 8, 16, 24 ]
  5. Influence on longterm quality of life measured by the EuroQol (EQ)-5D [ Time Frame: 6 months and 12 months ]
  6. Number of cancer survivors presenting with cognitive complaints as measured by Cognitive Failure Questionnaire [ Time Frame: Week 8, 16, 24 ]
  7. Influence of age on cognitive complaints in cancer survivors [ Time Frame: Week 8, 16, 24 ]
  8. Influence of gender on cognitive complaints in cancer survivors [ Time Frame: Week 8, 16, 24 ]
  9. Influence of distress on cognitive complaints in cancer survivors as measured by Distress Thermometer [ Time Frame: Week 8, 16, 24 ]
  10. Influence of fatigue (FACIT-Fatigue Scale) on cognitive complaints in cancer survivors [ Time Frame: Week 8, 16, 24 ]
  11. Influence of cancer type on cognitive complaints in cancer survivors [ Time Frame: Week 8, 16, 24 ]
  12. Influence of cancer stage on cognitive complaints in cancer survivors [ Time Frame: Week 8, 16, 24 ]
  13. Influence of the received treatment on cognitive complaints in cancer survivors [ Time Frame: Week 8, 16, 24 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02771028


Contacts
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Contact: Philip Debruyne, MD, PhD, FRCP 0032 56 63 39 00 philip.debruyne@azgroeninge.be

Locations
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Belgium
General Hospital Klina Brasschaat Recruiting
Brasschaat, Belgium, 2930
Contact: Langenaeken Christine, MD         
Principal Investigator: Langenaeken Christine, MD         
Brussels University Hospital Recruiting
Brussels, Belgium, 1090
Contact: Christel Fontaine, MD         
Principal Investigator: Christel Fontaine, MD         
General Hospital Groeninge Recruiting
Kortrijk, Belgium, 8500
Contact: Philip Debruyne, MD, PhD, FRCP         
Sponsors and Collaborators
General Hospital Groeninge
Universitair Ziekenhuis Brussel
AZ Klina

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Responsible Party: Dr. Philip Debruyne, Medical Oncologist, General Hospital Groeninge
ClinicalTrials.gov Identifier: NCT02771028     History of Changes
Other Study ID Numbers: AZGS2016034
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019