Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients
NCT ID: NCT04165460
Last Updated: 2025-05-28
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
NA
92 participants
INTERVENTIONAL
2020-03-02
2025-12-31
Brief Summary
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Detailed Description
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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.
Few evidences exist about psycho-social factors prevalence on gynecological cancer patients. The current available studies have grouped different types of gynecological cancer including breast, ovary, endometrium and vulva, but cervical cancer has been included only in a small proportion of those studies producing a certain degree of bias at the time of interpreting the results. Moreover, most of the studies has focused in breast and ovarian cancer patients. However, it has been proposed the existence of differences in psychological morbidity in women with cervical cancer, therefore is essential to focus our efforts in this particular population due to its high morbidity and mortality.
Hypothesis Patients with locally advanced and advanced cervical cancer receiving "A" psychological intervention will have a greater decrease in anxiety, depression, better coping responses, sexual satisfaction, therapeutic adherence and quality of life compared with the "B" psychological intervention.
The general aim of this study is to evaluate the effect of two cognitive-behavioral interventions on psycho-social factors and quality of life of cervical cancer patients with locally advanced and advanced disease.
Specific objectives:
1. To identify and to compare the degree of the psychosocial variables: anxiety, depression, coping responses, therapeutic adherence and sexual satisfaction at different evaluation phases (pre-intervention, post-intervention and follow-up) in cervical cancer patients.
2. To evaluate and to compare the health-related quality of life perceived at different evaluation phases (pre-intervention, post-intervention and follow-up) in cervical cancer patients.
Exploratory objectives:
1. To evaluate the degree of anxiety, depression, quality of life and the presence of Caregiver Burden Syndrome in primary caregivers before the psychological treatment given to cervical cancer patients.
2. To evaluate the association between psychological variables of the primary caregiver and the emotional distress and quality of life of their locally advanced and advanced cervical cancer patients.
METHODS
Study Design: This a prospective, experimental, longitudinal, open and randomized study
Study population: patients will be divided into two treatment groups ("A" and "B") for pre-intervention, post-intervention and a three months follow-up evaluation treated at the National Cancer Institute from Mexico.
Sample size:
According to the criteria of two proportions, a sample of 92 cervical cancer patients (two intervention groups) and their matched primary caregivers (92) was obtained.
Statistical analysis:
The processing and analysis of the database will be carried out with the SPSS version 22.0® package for Microsoft.
* Univariate analysis will be carried out to describe the study population. Descriptive statistics will be used to obtain measures of central tendency and dispersion, for continuous variables depending on their distribution, mean and standard deviation (parametric) or median and interquartile range (non-parametric) may be reported. For qualitative variables, the distribution of absolute and relative frequencies will be reported.
* Group homogeneity analysis: the general characteristics of the patients in both intervention groups will be evaluated to asses the balance and homogeneity. For quantitative variables t-Student of independent samples or U of Mann-Whitney will be used. For qualitative variables Chi-Square or Chi-Square trends will be used.
* To estimate the change in the variables of interest throughout the measurements in both intervention groups, ANOVA analysis of repeated measures or Friedmand will be carried out.
* To determine the clinical intra-subject changes, an analysis of individual replicates will be performed analyzing the pre-intervention, post-intervention and after three-month follow-up evaluation.
Procedure:
Patients affiliated to the MICAELA Program referred to the Psychooncology service will be considered as candidates for the study.
Informed consent obtention: after reading the Informed Consent, patients will be informed that their participation will consist on answering questionnaires for psychological assessment and psychological attention, if required. If the patient agree to participate, she will sign the Informed Consent document. A semi-structured interview will be applied to obtain socio-demographic and familiar psycho-pathological disorders history. Then, psychometric instruments will be applied.
Patients who are detected with distress or maladaptive coping will be randomized to one of the two interventions groups.
There will be scheduled ten weekly sessions of one hour approximately in with "A" Intervention or "B" Intervention will be applied according the group assigned by randomization. Then, patients will be scheduled for psychological treatment appointments and for evaluation after finishing treatment.
Ethical considerations:
Participants will be informed about details regarding the study, through the Informed Consent process. Patients that desire to participate will express their willingness with the sign of the Informed Consent document. Patients could leave the study at any time when desire.
The study will be conducted according to the ethical principles established in the documents adopted by the international community as declared at the Good Clinical Practices, the Nuremberg Code, the Declaration of Helsinki as well as the Guide of Good Clinical Practices of the Conference Harmonization International and anyone who represents the greatest protection for the individual.
According to the regulations of the General Health Law on Health Research, the second title on the Ethical Aspects of Research in Human Beings, Chapter I, Article 17, paragraph III, the proposed interventions on this study are considered as risk-free.
Protocol and Informed Consent have been approved by Institutional Research and the Ethics Committees.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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"A" Intervention
Psychoeducation, Relaxation, Cognitive Reestructuring and Problem Solving
Psychoeducation
Delivering systematic information about cancer, oncological treatment and efficient coping strategies.
Relaxation
Teaching the patient in diaphragmatic breathing retraining and passive relaxation with guided imagination.
Cognitive Restructuring
Teaching the patient to identify dysfunctional cognitions about cancer and oncological treatment that trigger maladaptive emotions and behavior. Then, focus in generating alternative thoughts through contrast with empirical reality based on the Beck Model.
Solving Problems
To generate alternative solutions to practical problems based on the model described by Nezu.
"B" Intervention
Psychoeducation, Relaxation
Psychoeducation
Delivering systematic information about cancer, oncological treatment and efficient coping strategies.
Relaxation
Teaching the patient in diaphragmatic breathing retraining and passive relaxation with guided imagination.
Interventions
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Psychoeducation
Delivering systematic information about cancer, oncological treatment and efficient coping strategies.
Relaxation
Teaching the patient in diaphragmatic breathing retraining and passive relaxation with guided imagination.
Cognitive Restructuring
Teaching the patient to identify dysfunctional cognitions about cancer and oncological treatment that trigger maladaptive emotions and behavior. Then, focus in generating alternative thoughts through contrast with empirical reality based on the Beck Model.
Solving Problems
To generate alternative solutions to practical problems based on the model described by Nezu.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Institute of Cancerología
OTHER_GOV
Responsible Party
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Lucely Cetina Pérez
Principal Investigator
Principal Investigators
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Jessica Salazar, MSc
Role: STUDY_CHAIR
National Cancer Institute from Mexico
Locations
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Instituto Nacional de Cancerologia
Mexico City, Tlalpan, Mexico
Countries
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References
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Related Links
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Other Identifiers
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INCAN
Identifier Type: OTHER
Identifier Source: secondary_id
019/026/ICI, CEI/1330/18
Identifier Type: -
Identifier Source: org_study_id
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