Effect of Two Cognitive-Behavioral Interventions on Cervical Cancer Patients

NCT04165460 | Enrolling By Invitation

• 2 other identifiers: 019/026/ICI, CEI/1330/18INCAN
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Psychological Distress; Coping Skills

Keywords

Cervical cancer; Quality of life; Coping; Distress; Anxiety; Depression; Therapeutic adherence; Sexual Satisfaction

Outcome Measures

Primary Outcomes (6)

• Change in Anxiety and Depression

  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.

  Six months

• Change in coping style

  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.

  Six months

• Change in general quality of life for cancer patients: EORTC QLQ-C30 v3, in spanish

  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).

  Six months

• Change in quality of life for cervical cancer patients: EORTC QLQ-CX 24

  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.

  Six months

• Changes in sexual satisfaction in women treated for cervical cancer

  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.

  Six months

• Changes in the Factors related to therapeutic adherence

  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.

  Six months

Secondary Outcomes (6)

• Physiological changes in blood pressure

  Two months

• Physiological changes in temperature

  Two months

• Physiological changes in heart rate

  Two months

• Physiological changes in breathing rate

  Two months

• Maladaptive thoughts changes

  During each Cognitive Reestructuring training session

Study Arms (2)

"A" Intervention

EXPERIMENTAL

Psychoeducation, Relaxation, Cognitive Reestructuring and Problem Solving

Other: Psychoeducation; Other: Relaxation; Other: Cognitive Restructuring; Other: Solving Problems

"B" Intervention

ACTIVE COMPARATOR

Psychoeducation, Relaxation

Other: Psychoeducation; Other: Relaxation

Interventions

Psychoeducation OTHER

Delivering systematic information about cancer, oncological treatment and efficient coping strategies.

"A" Intervention; "B" Intervention

Relaxation OTHER

Teaching the patient in diaphragmatic breathing retraining and passive relaxation with guided imagination.

"A" Intervention; "B" Intervention

Cognitive Restructuring OTHER

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.

"A" Intervention

Solving Problems OTHER

To generate alternative solutions to practical problems based on the model described by Nezu.

"A" Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cancerología: lead

Study Sites (1)

Instituto Nacional de Cancerologia

Mexico City, Tlalpan, 14080, Mexico

Location

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MeSH Terms

Conditions

Uterine Cervical Neoplasms; Anxiety Disorders; Depression; Treatment Adherence and Compliance; Orgasm

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Health Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica Salazar, MSc

  National Cancer Institute from Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: November 18, 2019
• Study Start: March 2, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)