Clinical trial NCT04165460: Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients
Official title: Effect of Two Cognitive-Behavioral Interventions on Psychosocial Factors and Quality of Life of Cervical Cancer Patients With Locally-advanced and Advanced Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Cancer
Psychological Distress
Coping Skills
Keywords: Cervical cancer
Quality of life
Coping
Distress
Anxiety
Depression
Therapeutic adherence
Sexual Satisfaction
Lead sponsor: National Institute of Cancerología
Sponsor class: OTHER_GOV
First posted: 2019-11-18
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Anxiety and Depression
timeFrame: Six months
measure: Change in coping style
timeFrame: Six months
measure: Change in general quality of life for cancer patients: EORTC QLQ-C30 v3, in spanish
timeFrame: Six months
measure: Change in quality of life for cervical cancer patients: EORTC QLQ-CX 24
timeFrame: Six months
measure: Changes in sexual satisfaction in women treated for cervical cancer
timeFrame: Six months
measure: Changes in the Factors related to therapeutic adherence
timeFrame: Six months
Secondary outcomes:
measure: Physiological changes in blood pressure
timeFrame: Two months
measure: Physiological changes in temperature
timeFrame: Two months
measure: Physiological changes in heart rate
timeFrame: Two months
measure: Physiological changes in breathing rate
timeFrame: Two months
measure: Maladaptive thoughts changes
timeFrame: During each Cognitive Reestructuring training session
measure: Correlation of anxiety, depression, caregiver burden syndrome and quality of life
timeFrame: at pretest
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
state: Tlalpan
Study officials:
affiliation: National Cancer Institute from Mexico
name: Jessica Salazar, MSc
role: STUDY_CHAIR
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