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

NCT02771028 | Completed

• 1 other identifier: AZGS2016034
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Subjective Cognitive Complaints; Cancer

Outcome Measures

Primary Outcomes (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

  Week 8, 16, 24

Secondary Outcomes (14)

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

  Week 8, 16, 24

• Change in psychological distress measured by Distress Thermometer

  Week 8, 16, 24

• Change in depressive symptoms measured by Beck Depression Inventory II

  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

  Week 8, 16, 24

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

  Week 8, 16, 24

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients assigned to intervention group receive an 8-week EFT-program

Behavioral: Emotional Freedom Techniques

Control group

NO INTERVENTION

Patients assigned to control group are placed on a waitlist for a period of 8 weeks

Interventions

Emotional Freedom Techniques BEHAVIORAL

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Groeninge: lead
• Universitair Ziekenhuis Brussel: collaborator
• AZ Klina: collaborator

Study Sites (3)

General Hospital Klina Brasschaat

Brasschaat, 2930, Belgium

Location

Brussels University Hospital

Brussels, 1090, Belgium

Location

General Hospital Groeninge

Kortrijk, 8500, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34466793 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Philip R Debruyne, MD, PhD, MSc, FRCP

  AZ Groeninge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: May 12, 2016
• Study Start: October 1, 2016
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2021
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

BE (3)