Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04165460
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-31
First Post:
2019-10-07
Brief Title:
Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients
Sponsor:
National Institute of Cancerología
Organization:
National Institute of Cancerología
Study Overview
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
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens health More than 83000 women were diagnosed with cervical cancer and 36000 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 220 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
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 220 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| INCAN | OTHER | Instituto Nacional de Cancerología | None |