Clinical trial NCT02771028: Emotional Freedom Techniques to Reduce Patient Reported Cognitive Complaints in Cancer Survivors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Complaints
Cancer
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
Collaborators: name: Universitair Ziekenhuis Brussel
name: AZ Klina
First posted: 2016-05-12
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in cognitive complaints measured by Cognitive Failure Questionnaire
timeFrame: Week 8, 16, 24
Secondary outcomes:
measure: Change in fatigue measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale
timeFrame: Week 8, 16, 24
measure: Change in psychological distress measured by Distress Thermometer
timeFrame: Week 8, 16, 24
measure: Change in depressive symptoms measured by Beck Depression Inventory II
timeFrame: Week 8, 16, 24
measure: Change in quality of life measured by the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30
timeFrame: Week 8, 16, 24
measure: Chang in quality of life measured by EQ-5D-3L
timeFrame: Week 8, 16, 24
measure: Change in long-term quality of life measured by the EuroQol EQ-5D-3L
timeFrame: 6 months and 12 months
measure: Number of cancer survivors presenting with cognitive complaints as measured by Cognitive Failure Questionnaire
timeFrame: Week 8, 16, 24
measure: Influence of age on cognitive complaints in cancer survivors
timeFrame: Week 8, 16, 24
measure: Influence of gender on cognitive complaints in cancer survivors
timeFrame: Week 8, 16, 24
measure: Influence of distress on cognitive complaints in cancer survivors as measured by Distress Thermometer
timeFrame: Week 8, 16, 24
measure: Influence of fatigue (FACIT-Fatigue Scale) on cognitive complaints in cancer survivors
timeFrame: Week 8, 16, 24
measure: Influence of cancer type on cognitive complaints in cancer survivors
timeFrame: Week 8, 16, 24
measure: Influence of cancer stage on cognitive complaints in cancer survivors
timeFrame: Week 8, 16, 24
measure: Influence of the received treatment on cognitive complaints in cancer survivors
timeFrame: Week 8, 16, 24
Other outcomes:
Locations:
city: Brasschaat
country: Belgium
facility: General Hospital Klina Brasschaat
city: Brussels
country: Belgium
facility: Brussels University Hospital
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge
Study officials:
affiliation: AZ Groeninge
name: Philip R Debruyne, MD, PhD, MSc, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.