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

G

General Hospital Groeninge

Status

Completed

Conditions

Subjective Cognitive Complaints
Cancer

Treatments

Behavioral: Emotional Freedom Techniques

Study type

Interventional

Funder types

Other

Identifiers

NCT02771028
AZGS2016034

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 2 patient groups

Intervention group
Experimental group
Description:
Patients assigned to intervention group receive an 8-week EFT-program
Treatment:
Behavioral: Emotional Freedom Techniques
Control group
No Intervention group
Description:
Patients assigned to control group are placed on a waitlist for a period of 8 weeks

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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