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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 6
- 主要终点
- Change in cognitive complaints measured by Cognitive Failure Questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Change in cognitive complaints measured by Cognitive Failure Questionnaire
时间窗: Week 8, 16, 24
Score of \<43 on the Cognitive Failure Questionnaire ; Minimum value: 0; Maximum value: 100; Higher scores mean worse outcome
次要结局
- 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)
- Influence of age on cognitive complaints in cancer survivors(Week 8, 16, 24)
- Influence of gender on cognitive complaints in cancer survivors(Week 8, 16, 24)
- Change in fatigue measured by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale(Week 8, 16, 24)
- Influence of cancer stage on cognitive complaints in cancer survivors(Week 8, 16, 24)
- Influence of the received treatment on cognitive complaints in cancer survivors(Week 8, 16, 24)
- Change in psychological distress measured by Distress Thermometer(Week 8, 16, 24)
- Change in long-term quality of life measured by the EuroQol EQ-5D-3L(6 months and 12 months)
- Influence of distress on cognitive complaints in cancer survivors as measured by Distress Thermometer(Week 8, 16, 24)
- Influence of fatigue (FACIT-Fatigue Scale) on cognitive complaints in cancer survivors(Week 8, 16, 24)
- Influence of cancer type on cognitive complaints in cancer survivors(Week 8, 16, 24)
- Number of cancer survivors presenting with cognitive complaints as measured by Cognitive Failure Questionnaire(Week 8, 16, 24)
研究者
Dr. Philip Debruyne
Medical Oncologist
General Hospital Groeninge