Effect of Two Cognitive-Behavioral Interventions on Psychosocial Factors and Quality of Life of Cervical Cancer Patients With Locally-advanced and Advanced Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change in coping style
研究概览
简要总结
Cancer represents the second cause of death in general population worldwide and according to statistics, it is expected to increase in the next 20 years. Cervical cancer is the fourth cause of morbidity and mortality among women around the world. Late diagnosis and treatment indices several emotional reactions in patients leading to psychological disorders with an impact in quality of life. Anxiety and depression are the most frequent emotional reactions in cancer patients, which may vary depending on psychosocial factors such as coping and family support, mostly provided by the primary caregiver. Despite the high psychological morbidity in cancer patients, it is estimated that, among those patients needing psychological support, only 10% receive such interventions. A growing interest on psychological interventions in oncology has increased in the last 40 years, however, scarce investigations have been performed, especially in cervical cancer patients. The Cognitive-Behavioral Therapy has proven to be beneficial in general cancer population decreasing the psychological symptoms and improving the quality of life. Thus, the aim of this study is to evaluate the effect of two Cognitive-Behavioral psychological interventions on anxiety, depression, coping, therapeutic adherence, sexual satisfaction and quality of life of cervical cancer patients with locally-advanced and advanced disease attended at the National Cancer Institute from Mexico. Psychological intervention will be provided during ten weekly sessions including psychoeducation, relaxation, cognitive restructuring and problem solving with a pretest, posttest performed one week after intervention, and finally a follow up after three months after finishing the psychological intervention.
详细描述
Cervical cancer is the fourth cause of morbidity and mortality worldwide, being one of the most important threats to women's health. More than 83,000 women were diagnosed with cervical cancer and 36,000 died in the Region of the Americas in 2012. This phenomenon will increase by 45% for 2030.
During the natural history of Cervical cancer, and as a consequence of therapeutic approaches, a certain proportion of the patients may have emotional reactions leading to psychological disorders, as severe as those disease complications, which also deteriorate their quality of life. The most frequent reactions are anxiety and depression. These may vary depending on different psychosocial factors, including coping and social support, mostly provided by the Primary Caregiver, who has a fundamental role in hospital and home care, helping on therapeutic adherence.
Therapeutic adherence is essential in order to obtain optimal results of the given oncological treatment, representing a mediating variable with important implications for survival, disease progression and in the improving of quality of life.
Response to treatment has been widely evaluated by tumor size, OS and DFS. Nevertheless, in the past tree decades the evaluation of Quality of Life has risen as an indicator of therapeutic response. Quality of life is an indicator that measures the general well-being of the patients according to the overall effects of the oncological treatments. Scientific evidence reports that cervical cancer survivors may have a worst quality of life as well as other physical and emotional symptoms than those observed in other cancer populations. Hence, it is necessary to focus on psychological interventions aimed to improve the quality of life and to decrease the psychological morbidity in cervical cancer patients.
During the last four decades a special interest in psychosocial interventions in oncology population has risen, establishing that Cognitive-Behavioral Therapy is beneficial in the reduction of physical and emotional symptoms of patients, promoting the adaptive coping and improving the quality of life.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PATIENTS:
- •Affiliated to the MICAELA (Modelo Integral para el Cáncer Cervicouterino Localmente Avanzado y Avanzado) program
- •Ability to understand the study and to provide signed informed consent
- •Diagnosed with locally advanced and advanced cervical cancer
- •Patients newly diagnosed or with recurrence about to start treatment
- •Patients with moderate or severe anxiety, and/or depression symptoms or maladaptive coping
- •PRIMARY CAREGIVERS:
- •Relatives, acquaintance or friends reported to be the principal caregiver of the patient
- •Relatives, acquaintance or friends who do not perceived economic remuneration for taking care of the patient
排除标准
- •PATIENTS:
- •Patients with psychological or psychiatric treatment or who received previous mental-health treatment.
- •Patients with any alteration of the Central Nervous System
- •Patients with moderated or severe cognitive impairment
- •Patients under palliative care or in terminal phase
- •PRIMARY CAREGIVERS
- •Caregivers with severe hearing and/or visual problems
- •Caregivers with a professional or technical training in patient care
- •Elimination criteria Patients referred to palliative care
结局指标
主要结局
Change in coping style
时间窗: Six months
Change in the Brief COPE-17 Inventory subescales scores The Brief COPE Inventory (COPE-17). Is a brief version of the COPE Inventory (Carver, et al., 1989). It has 17 items measured in a 0-3 point Likert scale, to evaluate coping strategies, that are grouped in seven subescales (planning, self-distraction, humor, seeking for social support, substance use, emotional-religious-spiritual support and self-blame). COPE-17 determines two primary coping styles either as approach coping or avoidant coping. It was adapted and validated in Mexico on a breast cancer population (Ornelas, et al., 2013), obtaining an internal alpha consistency of 0.70 either for the general scale and for each subescale. Avoidant Coping is characterized by the subscales of self-distraction, substance use and self-blame. Approach Coping is characterized by the subscales of planning and seeking for social support. Humor and Emotional-Religious-spiritual are neither Approach nor Avoidance coping.
Change in Anxiety and Depression
时间窗: Six months
Change in Hospital Anxiety and Depression Scale total score and in the two Subescales The Hospital Anxiety and Depression Scale (HADS-M) for Mexican patients. HADS was especially designed to detect anxiety and depression states of patients with chronic diseases. HADS-M is a HADS-modified version that has been validated in an oncological sample of patients in Mexican population. HADS-M comprises 12 items measured in a 0-3-point Likert scale, divided into two subescales, one for depression and one for anxiety. The validated version in Mexico has an internal consistency of alpha= 0.86 for global scale, and 0.79 for depression and 0.80 for anxiety subscales. Compared to other instruments, it has sensitivity to detect therapeutic changes associated to psychological interventions. The subscales score is categorized in without (0-5), low (6-8), moderate (9-11), and severe (12 or more) anxiety or depression.
Change in general quality of life for cancer patients: EORTC QLQ-C30 v3, in spanish
时间窗: Six months
Change in quality of life summary score of The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The EORTC QLQ-C30 questionnaire evaluates the quality of life in oncological population, is composed of both multi-item and single-item measures. It has 30 items, including nine scales: five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, pain and nausea / vomiting) and one global health status/QoL scale. Six single items are also included (Dyspnea, Insomnia, Appetite loss, Constipation, Diarrhea and Financial difficulties). A high score for all functional and global health/QoL scales represents a high/healthy level of functioning/high QoL, whereas a high score for a symptom scale/item represents a high level of symptoms/problems. The QLQ-C30 was validated in mexican population, obtaining a Crombach's coefficient of 0.7 (Oñate-Ocaña, et al, 2009).
Changes in sexual satisfaction in women treated for cervical cancer
时间窗: Six months
Changes in Screening Questionnaire aimed to identify sexual satisfaction in women treated for cervical cancer Screening questionnaire aimed at identifying sexual satisfaction in women treated for cervical cancer. To explore sexual activity and cognitive distortions about sexuality during and after oncological treatment, with 20 questions in a dichotomous yes/no response. It was developed for this study as part of the semi-structured screening interview in order to determine the cognitions that generate emotional distress and affectation in the quality of life.
Change in quality of life for cervical cancer patients: EORTC QLQ-CX 24
时间窗: Six months
Change in quality of life summary score and subescales using The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Cervical Cancer Module (EORTC QLQ-CX24). The EORTC QLQ-CX24 is the supplementary module of the QLQ-C30 aimed to evaluate quality of life of cervical cancer patients. It consists of 24 items divided in three multi-item scales to assess symptoms experience (gastrointestinal and genitourinary), body image and sexual/vaginal functioning, and six single items to assess lymphedema, peripheral neuropathy, menopausal symptoms, sexual worry, sexual activity and sexual enjoyment. The last five questions are answered only by patients with an active sex life. Higher scores are equivalent to worse or more symptoms, except for items 49 and 54 (higher score indicates better quality of life). The responses are in a 4-point Likert scale. There is a Spanish version used in Mexican population that was provided by EORTC to use in this study.
Changes in the Factors related to therapeutic adherence
时间窗: Six months
Changes in the Factors related to therapeutic adherence in cancer patients Scale subscales scores Scale to assess factors related to therapeutic adherence in cancer patients (Urzúa et al., 2012). This scale consists in 20 items measured in a 1-4 point likert scale, it evaluates three factors that may affect the therapeutic adherence of patients to oncological treatment. It has three subescales: a) Expectations and personal tools to face the disease, b) Beliefs about the treatment and c) Perceived effects of the treatment. It was developed especially for oncological population with an internal consistency of alpha=0.96 in the global scale and 0.9, 0.93 and 0.91 for the three subscales.
次要结局
- Physiological changes in temperature(Two months)
- Physiological changes in blood pressure(Two months)
- Physiological changes in heart rate(Two months)
- Maladaptive thoughts changes(During each Cognitive Reestructuring training session)
- Physiological changes in breathing rate(Two months)
- Correlation of anxiety, depression, caregiver burden syndrome and quality of life(at pretest)
研究者
Lucely Cetina Pérez
Principal Investigator
National Institute of Cancerología