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

NCT ID: NCT02771028

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2021-03-15

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.

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.

Conditions

Subjective Cognitive Complaints; Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Emotional Freedom Techniques

Intervention Type: BEHAVIORAL

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Emotional Freedom Techniques

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

AZ Klina

OTHER

Sponsor Role: collaborator

General Hospital Groeninge

OTHER

Sponsor Role: lead

Responsible Party

Dr. Philip Debruyne

Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip R Debruyne, MD, PhD, MSc, FRCP

Role: PRINCIPAL_INVESTIGATOR

AZ Groeninge

Locations

General Hospital Klina Brasschaat

Brasschaat, , Belgium

Brussels University Hospital

Brussels, , Belgium

General Hospital Groeninge

Kortrijk, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 34466793 (View on PubMed)

Other Identifiers

AZGS2016034

Identifier Type: -

Identifier Source: org_study_id